Description

Who We Are

BioMarins Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarins cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients.

The CMC Project Manager role is critical for coordination-based responsibilities in support of BioMarins product portfolio within Technical Operations (TOPS) and within the CMC integration department.  The CMC PM Provides Project Management Support to enable successful program execution and ensures alignment across partner team leads in partnership with the CMC Team Lead.Under minimal supervision this position supports cross-functional partnerships across BioMarin to ensure the availability of our portfolio of products to external partners, customers and patients.  You will support cross functional alignment on product and portfolio strategies and their execution and will serve as a key point of contact for collaborations with CMC team colleagues. You will serve as a subject matter expert and strategic partner to educate on how we operationalize a strategy and support leadership decision making and develop solutions to complex problems.

RESPONSIBILITIES AND LEARNING OPPORTUNITIES

• The CMC PM Provides Project Management Support to enable successful program execution and ensures alignment across partner team leads, in partnership with the CMC Team Lead.
• Responsible for driving, deploying, and maintaining the CMC Strategic plan in alignment with Product strategy and in partnership with CMC Team members.
• Responsible for maintaining program management and portfolio deliverables in partnership with CMC Team members (e.g maintaining risk registers and decision logs)
• Effectively manage team meetings, including the scheduling of meetings, the preparation of agendas, the development of meeting minutes, and following up on action items.
• Responsible for preparing CMC Team communication materials to communicate project progress to stakeholders, supervisors, site leadership, and various governance forums as needed e.g., status reports, milestones reporting for diverse leadership groups etc.
• Responsible for facilitating dialogue as well as collation and maintenance of materials for CMC stage gate reviews
• Responsible for working with team members to create and maintain project plans and timelines, highlighting key areas of risks such as resource or budget gaps, dependencies, and target dates
• Responsible for identifying and communicating dependencies and cross-project synergies to leverage efficiencies and ensure consistencies and standardization where appropriate within CMC team
• Identify project issues such as resource, technical or scheduling constraints and drives resolution of these issues with the CMC Team and with external stakeholders by developing program-level risk assessments, summarized options, and proposed solutions with impact statements
• Promote a culture of collaboration, cooperation, execution excellence, effective communication, and cross-functional problem-solving to enable a high-performing team.
• Tracks program timelines elements to ensure that functional deliverables are completed on time and according to relevant quality standards.
• Support identifying cross-project synergies to leverage efficiencies and ensure consistencies where appropriate.
• Contributes to best practices and improvements.
• Supports training and roll out of portfolio standard and guidance.
• Manages projects supporting continuous improvements of best program management practices.  

QUALIFICATIONS AND EXPERIENCE

• Minimum of 4-8 years total relevant experience (including industry, project management, or private/government institution), with at least 2-4 years in a project management role
• Minimum Bachelors degree in scientific/technical discipline
• Demonstrated ability to organize and update a complex schedule, experience with project management software such as Microsoft project, P6 Primavera or other
• Ability to understand the big picture and focus on execution details
• Experience in early-stage CMC development is a plus
• Proven track record in a fast-paced, challenging, and complex matrixed team environment
• High degree of demonstrated learning agility
• Action-oriented with strong follow through
• Strong interpersonal skills; fluent and able to influence others in spoken and written English
• Strong risk management analysis and project management skills
• Strong computer skills, MS Office, MS Word, MS PowerPoint, MS-Project is preferred.
• Highly developed interpersonal skills with the proven ability to function effectively and tactfully with multiple departments and personnel, able to gain consensus and commitment

Nice to Have Skills/Experience:

• Understanding of biotech or drug product development and of multi-project planning and coordination is required.
• Experience with CMC activities for development programs (Clinical stage) a plus
• Exposure to portfolio management a plus
• Lean-DMAIC expertise, Green belt or higher certification.
• Strong regulatory and GMP acumen, specifically ICH8-12.
• PMP Certification

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law.

In the U.S., the salary range for this position is $ 104,000 to $ 156,000 per year, which factors in various geographic regions. The base pay actually offered will take into account internal equity and also may vary depending on the candidate's geographic region, job-related knowledge, skills, and experience among other factors. A discretionary bonus and/or long-term incentive units may be provided as part of the compensation package, in addition to the full range of medical, financial, and/or other benefits, dependent on the level and position offered.

Description

Manager, Learning Community

BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options. BioMarin will continue to focus on advancing therapies that are the first or best of their kind.

BioMarins Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists, and support staff build and maintain BioMarins cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients. Come join our team and make a meaningful impact on patients lives.

What we're looking for

Effective training programs are critical in a regulated manufacturing business and this position plays an essential role in ensuring employees continue to buildskills that will enable them tobe successful andcontinue their professional development.

This is a dynamic position that requires a high degree of professional and collaborative interaction and an innovative spirit.TheLearning Community Manager will be accountable for helpingfacilitate andbuild a community of engaged learners at BioMarin.

Tasked with the design, development, and delivery of professional development opportunities, key objectives of the role include:

Develop and implement scalable learning-professional "community" through the development of programs and resources to facilitate continuous learning.

Partner with key departments/ key stakeholders and provide support for employee capabilitybuildinginitiatives.

Build a learning organization which attracts top talent as a place to come and grow through best-in-class, unique and memorable experiencesranging from on-boarding through development.

Design, manage, and implement technical training, onboarding,learning and development programs and projects.

Programme ownership includesNovato site New Hire Orientation, New Hire Training, Train the Trainer, andvarious form of knowledge sharing forums includingLunch & Learn sessions.

Maintain working knowledge of best practices and cutting-edgetechnologies and processes in organizational effectiveness to determine new approaches to emerging training requirements.

Collaborate and support internal L&D team to drive and influence people development/L&D process improvements that impact results.

Skills you will need

Experience and skills were looking forinclude;

• 5-10 years experiencein a regulated industry with a postgraduate and or working qualification in learning and development, technical training, or relevant discipline (organizational development, psychology, business, instructional design).
• Good knowledge of technical training curriculum and design processes and development of skills qualification is essential.
• The ideal candidatewould be skilled in the use of instructional design principles and training programs such as Articulate Storyline 360, Camtasia, Vimeo.
• Exceptional interpersonal, communication and relationship building skills with the ability to be assertive, diplomatic, and tactful with a diverse population group.
• Demonstrated ability to work independently and as part of a team in a fast-paced and changing work environment.
• Exceptional organizational skills and attention to detail.
• Strong project management capabilities ability to manage multiple projects, engage stakeholders throughout the process and meet deadlines.
• Team player focused on understanding the needs of all stakeholders.
• Takes direction well, can work independently while having the confidence to seek guidance and direction as needed.
• Solution-oriented and able to uncover pathways to efficiency through strong analytical and problem-solving skills.
• Strong leadership skills and ability to influence others and lead across the business.

Work Environment

This position will be based at the Novato campus.

Schedule

Monday - Friday 8:00AM 5:00PM

Hybrid role: fully onsite 1 week per month during New Hire Orientation, subsequent weeks 2-3 days in the office and 1-2 days remote (This is subject to change based on need.)

 We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law. 

In the U.S., the salary range for this position is $ 116,800 to $ 175,200 per year, which factors in various geographic regions. The base pay actually offered will take into account internal equity and also may vary depending on the candidate's geographic region, job-related knowledge, skills, and experience among other factors. A discretionary bonus and/or long-term incentive units may be provided as part of the compensation package, in addition to the full range of medical, financial, and/or other benefits, dependent on the level and position offered.

Description

Who We Are

BioMarins Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarins cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients.

Come join our team and make a meaningful impact on patients lives. 

SUMMARY

Manufacturing Science and Technology (MSAT) at BioMarin is the technical partner for clinical and commercial operations and actively supports manufacturing processes throughout the product lifecycle. We are an inclusive, high-performing, highly motivated, and collaborative group looking for an innovative and passionate individual with strong cell culture skills and an engineering background to become an integral part of our upstream team. You will join a team of scientists and research associates working to resolve manufacturing challenges, evaluating new technologies, and facilitating continuous process improvement to ensure robustness for our biologics and adeno associated virus (AAV) viral vector production process.

The selected candidate will be a highly motivated individual, who has strong cell culture skills and familiar with large scale cell culture operations. Applicants who have experience with troubleshooting bioprocesses and are familiar with chemical engineering principles (e.g. mass balances, reactor design, mass/heat transfer, etc.) are preferred. Majority of the work will be lab based involving mammalian cell culture, lab-scale bioreactor operations and execution of analytical methods. The individual will develop experimental studies to troubleshoot and better understand BioMarins commercial cell culture and fermentation processes. This individual must have strong communication skills, as they will be involved in projects that involve presenting data to collaborators and will assist in writing memos, protocols and reports.

The ideal candidate is a self-starter, who focuses on transparent and honest communication, is dependable, cares intensely about helping others, and is comfortable making decisions while dealing with uncertainty.

RESPONSIBILITIES

• You will assist in the design and execution of studies to enable continuous process improvements of BioMarin's commercial manufacturing processes.
• Working with other researchers and scientists in the team, you will operate bench scale bioreactors and automated, high throughput bioreactor systems (ambr15 and ambr250) for routine commercial manufacturing support. 
• You will perform analytical assays (HPLC, ELISA, ddPCR) related to experimental studies. 
• You will support investigations that help us understand and resolve complex manufacturing issues and assess their potential impact to product quality.
• You will evaluate raw materials for use in commercial manufacturing processes for our enzyme replacement therapies and gene therapies.
• You will have opportunities to evaluate novel technologies that will support future commercial manufacturing processes.
• As a researcher, you will document experimental data, interpret results and support data analysis. You will also assist in writing memorandums, protocols and reports.

DESIRED EXPERIENCE

• Bench scale or commercial scale cell culture experience including mammalian fed batch or perfusion processes, bacterial fermentation is desired. 
• Knowledge of viral vector production and/or related analytical assays (ELISA, ddPCR) is a plus.
• Experience with troubleshooting of cell culture processes.
• Accurate documentation of experimental work, data analysis and results.
• Demonstrated record of strong communication skills.

EDUCATION

 B.S. in Chemical/Biochemical/Biomedical Engineering or related disciplines. Candidates with Associate's degree and 2+ years of manufacturing experience are also encouraged to apply. 

SUPERVISOR RESPONSIBILITY

 None.

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law.

In the U.S., the salary range for this position is $ 65,600 to $ 98,400 per year, which factors in various geographic regions. The base pay actually offered will take into account internal equity and also may vary depending on the candidate's geographic region, job-related knowledge, skills, and experience among other factors. A discretionary bonus and/or long-term incentive units may be provided as part of the compensation package, in addition to the full range of medical, financial, and/or other benefits, dependent on the level and position offered.

Description

Who We Are

BioMarins Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarins cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients.

Novato Site is seeking a manufacturing execution system (MES) Implementation Lead to oversee MES deployment and integration into the Novato site. You will be part of Novato Business Operations, an organization that drives operational excellence, productivity efforts, learning and development, and technical operations. In the role of Implementation Lead, your main function is to partner with a core team to design, develop, implement, and create sustainment strategies to deploy MES software. This will help optimize manufacturing processes, reduce errors, and increase efficiency, by integrating production operations with business systems. This is a multi-year journey that will require close collaboration with other major software deployments such as SAP and DeltaV.

You will coordinate project deliverables, be accountable for change management activities, and provide regular updates to site leadership and governance counsels. You will provide direct guidance to contract employee and full-time employees while managing to a schedule, managing risks and escalating issues as they arise.

You will leverage work performed to implement MES at the BioMarin Shanbally, Ireland site while iterating upon the model for the Novato operational landscape. This work includes the creation of electronic batch records, electronic logbooks, equipment selection, and GMP equipment/systems integration for the commercial manufacturing areas in Novato and manufacturing support functions. Travel to Shanbally, Ireland may be requested to support information sharing and alignment across the sites. 

Leader Attributes:

• Demonstrated resilience & agility
• Big Picture mindset
• Understanding of the Novato Manufacturing operational landscape
• Builds trust and respect with colleagues
• Confident decision maker using incomplete information
• Holds others accountable to commitments made
• Desire to learn more about the business
• Builds positive relationships to move the work & business forward

Skills Needed:

• Technical knowledge and experience to integrate operational processes with business systems.
• Must have a strong understanding of Manufacturing processes and practices.
• Must have a combination of technical and soft skills to effectively collaborate with cross-functional teams and drive continuous improvement in manufacturing operations.
• Must stay up to date with emerging trends in MES technologies.
• Must ensure documented processes and procedures are in place for all activities to meet quality and compliance standards. Experience with GMP regulations.
• Ensure MES system is in compliance with industry-specific regulations, such as FDA guidelines and GMP requirements, BioMarin corporate policy and procedures, and local procedures to maintain product quality and safety.
• Must have Strong Problem-solving skills (Lean Six Sigma Certification a plus).
• Must have Excellent communication skills.

Additional Preferences:

• Deep knowledge and experience with MES platforms such as PAS-X
• Expertise with related technologies and standards, and data historians.
• Understanding of cybersecurity concepts and best practices related to MES technologies.
• Understanding of regulatory requirements in GMP (Good Manufacturing Practice), such as FDA regulations for pharmaceutical manufacturing.
• Adaptability and flexibility to work in a fast-paced, dynamic environment and manage multiple tasks simultaneously.
• Experience with Computer System Validations.
• Experience with technical mentoring and developing technical team members.

Minimum Requirements:

• Minimum of 10+ years of experience working in Manufacturing and with business systems such as MES

Education Requirements:

• Bachelors degree in Software Engineering, Computer Science, Computer Engineering, Life Sciences, or a related field

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law.

In the U.S., the salary range for this position is $ 144,000 to $ 216,000 per year, which factors in various geographic regions. The base pay actually offered will take into account internal equity and also may vary depending on the candidate's geographic region, job-related knowledge, skills, and experience among other factors. A discretionary bonus and/or long-term incentive units may be provided as part of the compensation package, in addition to the full range of medical, financial, and/or other benefits, dependent on the level and position offered.

Description

Who We Are

For more than two decades, going our own way has led to countless breakthroughs, bettering the lives of those suffering from rare genetic disease. In 1997 we were founded to make a big difference in small patient populations. Now we seek to make an even greater impact by applying the same science-driven, patient-forward approach that propelled our last 25 years of drug development to larger genetic disorders, as well as genetic subsets of more common conditions. Through our unparalleled expertise in genetics and molecular biology, we will continue to develop targeted therapies that address the root cause of the conditions we seek to treat. Applying our knowledge to make a transformative impact is not just a calling, but an obligation to those who will benefit most. The end goal has always been better lives and now we can reach more.

And the more people we reach, the more our impact can grow. We transform lives through genetic discovery.

Our Culture

Our desire to make a positive impact on our patients extends to our employees and BioMarin is committed to fostering an inclusive environment where every person feels seen, valued, and heard so employees can thrive in all areas of their lives, in and outside of work. We seek to provide an open, flexible, and friendly work environment to empower people and to provide them with the ability to develop their long-term careers. Ultimately, we want to be an organization where people enjoy coming to work and take pride in our efforts to help patients.

BioMarins Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarins cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients. Come join our team and make a meaningful impact on patients lives.

Associate, Critical Reagent and Reference Standard Inventory Management

The core function of this role is to support and maintain the centralized program management of reference standards and critical reagents used in the testing and release of clinical and commercial products. 

The role is responsible for all activities related to monitoring material consumption rates, material inventory levels and all qualification/requalification tasks required to support reference standards and critical reagents supply.

The Critical Reagent and Reference Standard Inventory Management Associate reports to the Associate Manager in Quality Control Analytical Technologies.

RESPONSIBILITIES

Detailed responsibilities include but are not limited to the following:

• Monitors and supports the integrated inventory management process.
• Participate in the reference standard qualification document lifecycle authoring, review, approval, etc.
• Responsible for critical reagent and reference standard preparation, qualification testing coordination and release for use.
• Participate in projects to meet timelines to ensure on-time delivery of results and establish priorities for final reports.
• Initiate and assist with quality investigations, incident reports and the implementation of Corrective Actions and Preventative Actions related to the Critical Reagent and Reference Standard Inventory Management.
• Provide support to the department leadership with the implementation of new systems and continuous improvement efforts.
• Participate in the generation of new ideas to create efficiencies and improve processes; willingly supports new ideas and process enhancements.
• Maintain product quality by establishing and applying quality standards.
• Assist with regulatory and internal inspections, as needed.

Core Competencies:

• Ownership and Accountability  Takes accountability for actions, drives results, and able to learn from mistakes. Delivers on promises, goals, and expectations. Makes quality decisions and resolves problems with minimal delay as appropriate. Asks what can I do to help?
• Communication - Ability to communicate effectively up and down, at all levels of the organization, present complex and/or new ideas with clarity and simplicity.  Ability to draft and deliver clear and concise procedures or business process documents.
• Planning - Proficient planning and prioritization skills with the ability to multitask and adapt.  Able to synthesize large amounts of information.  Able to deliver results despite shifting environment.
• Analytical Problem Solving  Ability to identify problems, define problem statement clearly and accurately and apply structured and disciplined methodology to identify data-driven root causes.  Innovative and effective in solution development, risk mitigation, and execution.
• Customer focus - Partners with customers, looks ahead to predict future customer needs. Manages expectations.

 EXPERIENCE

Required Skills:

• Minimum 4 years of experience in a Quality/Compliance/Regulatory setting
• Knowledge of cGMPs and equivalent industry regulations
• Experience with technical oversight of Deviations and CAPAs
• Proficiency with computer systems Microsoft Office Suite
• Proficiency with TrackWise or QMS, LIMS, EDMS, and Office365 preferred

EDUCATION

BS in a technical science field

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law.

In the U.S., the salary range for this position is $ 72,000 to $ 108,000 per year, which factors in various geographic regions. The base pay actually offered will take into account internal equity and also may vary depending on the candidate's geographic region, job-related knowledge, skills, and experience among other factors. A discretionary bonus and/or long-term incentive units may be provided as part of the compensation package, in addition to the full range of medical, financial, and/or other benefits, dependent on the level and position offered.

Description

Who We Are

For nearly three decades, going our own way has led to countless breakthroughs, bettering the lives of those suffering from rare genetic disease. In 1997 we were founded to make a significant difference in small patient populations. Now we seek to make an even greater impact by applying the same science-driven, patient-forward approach that propelled our last 25 years of drug development to larger genetic disorders, as well as genetic subsets of more common conditions. Through our unparalleled expertise in genetics and molecular biology, we will continue to develop targeted therapies that address the root cause of the conditions we seek to treat. Applying our knowledge to make a transformative impact is not just a calling, but an obligation to those who will benefit most. The end goal has always been better lives and now we can reach more.

And the more people we reach, the more our impact can grow. We transform lives through genetic discovery.

Our Culture

Our desire to make a positive impact on our patients extends to our employees and BioMarin is committed to fostering an inclusive environment where every person feels seen, valued, and heard so employees can thrive in all areas of their lives, in and outside of work. We seek to provide an open, flexible, and friendly work environment to empower people and to provide them with the ability to develop their long-term careers. We want to be an organization where people enjoy coming to work and take pride in our efforts to help patients.

BioMarins Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists, and support staff build and maintain BioMarins innovative manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients. Come join our team and make a meaningful impact on patients lives.

JOB SUMMARY:

The Executive Director of Global Quality Assurance will provide strategic quality systems and quality compliance leadership in the GMP, GCP and GDP areas within scope and will be responsible for the integrated Quality Management System (QMS) across TOPS, including Technical Development, Global Operations & Supply, in support of the product lifecycle. This position will also be accountable for the performance of the Global Quality Assurance processes providing strategic direction and guidance to the reporting functions, and assuring end-to-end harmonization of quality processes, where needed. The person in this role is also responsible for providing QMS governance and controls, to ensure the global organization operates in compliance with our quality system and mitigates identified compliance and quality risks throughout the product life cycle for the products developed and manufactured at or on behalf of BioMarin.

The Executive Director of Global Quality Assurance plays an integral role in fostering a culture of quality, through the effective implementation of the QMS, ensuring that effectiveness and efficiency, from a performance perspective, is managed and continuously improved to sustain compliance with current and evolving global health authority requirements and regulations, and in keeping with external industry trends inclusive of Corporate GXP Compliance audits, Health Authority inspections and KPI measurements.

Reporting to the SVP, Chief Quality Officer, the Executive Director of Global Quality Assurance is responsible for the Global Quality Management System and oversight, Quality Risk Management (QRM), Annual Product Review, Global Document Management, Global Quality Issue Management (GIM), Product Complaints, Product Recall, Data Integrity Quality Oversight, and Supplier Quality Management. This position involves working closely with all quality functions and partners across TOPS (Technical Development, Engineering, Manufacturing Operations, MSAT, Supply Chain) as well as groups outside of TOPS (Regulatory Affairs, GXP Compliance, and Commercial) and will be a member of the Global Quality Leadership Team (QLT).

This position requires a broad range of knowledge and experience with quality assurance, quality systems and regulatory compliance, understanding the international regulatory landscape for the manufacturing, packaging and distribution of API, DS and DP for all modalities within the BioMarin TOPS network. The leader must possess executive leadership qualities, business acumen and technical expertise in the areas of responsibility.

RESPONSIBILITIES:

• Provide leadership, vision, and direction to the Global Quality Assurance Organization to ensure it contributes to becoming a World Class Quality Organization and to achieve the TOPS Strategy and Corporate objectives.
• Establish and maintain risk-based and fit-for-purpose global quality management (QMS) system ensuring effective implementation, which is managed and continuously improved to sustain compliance with current and evolving global health authority requirements and regulations effectively and efficiently.
• Lead Quality Management Review activities and oversee trending of key GMP quality management system performance metrics. Report and escalate compliance issues to management.
• Collaborate with global and site stakeholders to identify, define, and implement opportunities for improved QMS Process Workflows
• Develop, implement, and communicate quality policies, standards, and procedures to ensure consistency across the network and alignment with global processes.
• Mature the Quality Risk Management (QRM) program. Collaborate with key stakeholders within TOPS in QRM knowledge management, definition of roles and responsibilities and overall integration of QRM.
• Assess GMP and regulatory compliance risk areas and develop and implement risk mitigation measures in conjunction with the accountable parties.
• Oversees and leads quality and compliance risk management initiatives to minimize risk and potential impact of quality and/or non-compliance events
• Provide leadership and direction regarding supplier quality management strategy and systems to ensure the suppliers meet appropriate regulatory requirements and standards set by BioMarin (does not include CMOs/CDMO/s or Contract Labs)
• Provide leadership for data integrity initiatives and Quality digital technology roadmap implementation
• Provide leadership in global issue management (GIM) including product complaints and product recall process management and reporting.
• Establish and maintain process and systems in support to product launch readiness compliant with marketing authorizations, established specifications management, and quality approval requirements in compliance with regulations and other applicable standards.
• Explore innovative approaches to facilitate efficiency in the day-to-day operations and quality improvement projects
• Lead and mentor a team of Quality professionals to navigate and lead in a matrix organization.
• Develop and manage department budgets and long-range plans for the team.

EXPERIENCE:

• 15+ years of experience with Biotechnology, Pharmaceutical, Medical Device or other highly regulated industry
• Extensive knowledge and experience in GMP, GCP and GDP global regulations, principles, concepts, practices, and standards.
• Prior experience and broad range of knowledge in Quality, Compliance, or a combination of experience such as Manufacturing, Quality, and Regulatory required. In-depth knowledge in international regulatory landscape preferred
• Experience in Computer System Validation, Analytical Methods development/transfer, Quality Systems, Product Quality complaint, combination Products/Device Quality desirable
• 10+ years of prior management level experience with demonstrated ability to develop and mentor staff, and have managed a global organization involving diverse cultures and employees
• Demonstrated ability to work effectively in a matrix environment and drive results through influence as well as direct management
• In-depth experience in managing teams, and in providing coaching, development and mentoring to employees
• Excellent interpersonal and communication skills and ability to influence diverse stakeholders and drive accountability and decision-making cross functionally
• Demonstrated ability to partner with other functional group to achieve business objectives

EDUCATION:

• BA/BS/Ph. D in life sciences or related field
• Advanced degree desirable, but not required

OTHER:

• Ability to travel up to 20% as required
• Strong preference for candidates local to Novato, CA.  But open to a fully remote arrangement.

We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law.

In the U.S., the salary range for this position is $ 232,000 to $ 348,000 per year, which factors in various geographic regions. The base pay actually offered will take into account internal equity and also may vary depending on the candidate's geographic region, job-related knowledge, skills, and experience among other factors. A discretionary bonus and/or long-term incentive units may be provided as part of the compensation package, in addition to the full range of medical, financial, and/or other benefits, dependent on the level and position offered.

Description

Who We Are

From research and discovery to post-market clinical development, our WWRD engine involves all bench and clinical research and the associated groups that support those endeavors. Our teams work on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with genetic diseases.

THIS ROLE IS HYBRID AND REQUIRES WORKING IN SAN RAFAEL A MINIMUM OF 2 DAYS PER WEEK

 BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating, and have few, if any, treatment options. BioMarin aims to improve life and health outcomes for people with rare diseases by advocating the use of innovative BioMarin therapeutics, advancing the standard of care, and providing personalized support and services globally.

The BioMarin Global Study Operations function is tasked with providing strategic direction on the feasibility, design, and conduct of clinical studies and drives the delivery of high-quality data to support the registration and approval of clinical development assets. The function achieves this through the development and operationalization of Clinical Development Plans, study planning and delivery, cross-functional leadership of Study Execution Teams, operational trial expertise, and vendor management and oversight.

Role Summary:

The Study Specialist I (SS I) responsible to complete tasks related to the administrative support of study teams and department members and efforts. The SS I is not allocated as a resource to any specific study or program. Administrative tasks and activities may be requested by a line manager, study team member, or GSO department staff. Assignments may include contributing to or supporting teams as an ad-hoc or SWAT resource and in some cases may require line manager approval depending on level of effort and/or duration.

Activities and responsibilities may include:

• BOARD Quarterly MVR GSO Compliance and other metrics
• SRDO Program Roster updates and maintenance
• GSO Department Website maintenance
  • Knowledge Manager; responsible for maintaining the department website, GSO Dept Teams locations, and reconciling/filing between Teams and the GSO SharePoint Content Center
• The below tasks may also be included when unsupported by study staff and/or CRO:
• eTMF and SharePoint/Teams documents; may include upload, correction, review, and reporting
• Clerical assistance to arrange internal/external meetings and teleconferences
• Process documents for DocuSign signatures (e.g., facilitate and/or support IP package review/signatures, ICF signatures)
• Assist with tracking and review of Clinical Trial Insurance requirements, expiry dates, insurance renewal, certificate distribution, and archival
• Support mass communications via email or mailings

Skills:

• Relevant administrative experience including detail oriented, collaborative, positive attitude, ability to prioritize, proactive, and good follow up skills,
• Proficient in MS Suite; Excel, Word, Outlook, Zoom, and Teams

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law.

In the U.S, the salary range for this position is $ 31 to $ 50 per hour. The base pay actually offered will take into account internal equity, and may also vary depending on candidates geographic region, job-related knowledge, skills, and experience amongst other factors.

In the U.S., the salary range for this position is $ 31 to $ 50 per year, which factors in various geographic regions. The base pay actually offered will take into account internal equity and also may vary depending on the candidate's geographic region, job-related knowledge, skills, and experience among other factors. A discretionary bonus and/or long-term incentive units may be provided as part of the compensation package, in addition to the full range of medical, financial, and/or other benefits, dependent on the level and position offered.

Description

Who We Are

From research and discovery to post-market clinical development, our WWRD engine involves all bench and clinical research and the associated groups that support those endeavors. Our teams work on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with genetic diseases.

BioMarins Experimental Medicine is a group of physician-scientists that support pipeline advancement and growth of the clinical portfolio.  As an Early Clinical Development function, our group of physician-scientists link research initiatives and technical assessments of external innovation to areas of development based on fundamental understanding of genetics, molecular mechanisms, disease phenotypes, and medical need in specific patient populations. We seek a neurology trained physician-scientist to support the early clinical development of a broad portfolio of programs in neurogenetic diseases. 

RESPONSIBILITIES:

• Support neurogenetic programs within Experimental Medicine as a primary early clinical lead
• Help design and conduct early clinical studies, from natural history through treatment proof-of-mechanism clinical trials
• Author translational and pre-treatment plans based on research results
• Interrogate natural history and disease progression of therapeutic indication to plan a development strategy encompassing biomarkers, endpoints, and target patient population
• Serve as subject matter expertise of genetically driven neurologic disease by keeping current with literature, meetings, and disease pipeline
• Work collaboratively with research and clinical groups to advance programs
• Help generate development plans, draft product characterization, first-in-human and proof of concept trial strategy, draft clinical development plans
• Early clinical representative in investigative new drug (IND) filing team
• Represent Early Clinical Development in scientific advisory and academic meetings
• Identify high value therapeutic targets for neurogenetic indications and contribute clinical expertise to groups involved in disease mapping and pipeline strategy
• Work with Research, Innovation Accelerator and Business Development to facilitate clinical diligence of new development opportunities
• Participate in scientific advisory boards convened by BioMarin to support the research initiatives in neurogenetics

QUALIFICATIONS:

• MD or MD/PhD required
• Strong record of academic, basic and/or translational research productivity
• Solid foundation and interest in mechanisms of neurogenetic diseases
• Board certified or eligible in adult or pediatric neurology
• Interest and curiosity in development challenges
• Effective and impactful in cross-functional team structure
• Excellent communication skills, with a desire to develop strong internal and external collaborations

PLEASE NOTE: Absent a Medical or Religious reason that prohibits vaccinations, all our incoming employees must be vaccinated for COVID-19.

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law.

In the U.S., the salary range for this position is $ 184,000 to $ 276,000 per year, which factors in various geographic regions. The base pay actually offered will take into account internal equity and also may vary depending on the candidate's geographic region, job-related knowledge, skills, and experience among other factors. A discretionary bonus and/or long-term incentive units may be provided as part of the compensation package, in addition to the full range of medical, financial, and/or other benefits, dependent on the level and position offered.

Description

Who We Are

BioMarins Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarins cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients.

Director, Capital Projects PM

BioMarin leads the biotechnology industry in delivering therapies for chronic and degenerative
genetic conditions that reduce patients' quality of life and shorten life spans. We target diseases
that lack effective therapies and affect relatively small numbers of patients, many of whom are
children. BioMarin will continue to focus on advancing therapies that are the first or best of their
kind and make a big difference in improving patients' lives.

SUMMARY

Manage all aspects of various GMP and or non-GMP capital projects within the Technical
Operations Organization (TOPs). The Director Capital Projects PM, within the Capital Projects
Management (CPM) Group, will be responsible for the planning, design, execution,
commissioning, qualification, and close out phases of various capital projects. The Director will
be accountable for scope, schedule and budget of assigned projects and possibly other non-GMP
projects. The Director will provide financial reporting & projections, management
communication, capital expenditure portfolio updates, etc. for the various managed projects.

RESPONSIBILITIES
Manage the scope, deliverables, schedule, project team, and budget for TOPs capital
expenditure (CapEx) projects.
Prepares and updates project status and cost reports within Oracle Primavera for the use
of numerous BMRN departments.
Build and oversee various cross functional teams.
Executes a capital project plan that is in compliance with company standards, applicable
codes, and regulations.
Evaluates, prepares, & submits CapEx project intake forms for project submission and
review by executive management.
Assist CPM Portfolio Manager with project information and data collection on assigned
projects.
Participate with the generation of project cost accrual information, in service dates,
financial long range planning, & other financial and planning exercises.
Coordinate/support QA Validation group for GMP projects with design documents and
protocol review/execution.
Proactively look for and recommend improvements for site processes and procedures.
Represent the CPM Group with good communication and presentation skills.
Ensure safety measures are appropriately addressed on all projects.

EDUCATION
BS engineering degree from an accredited university or equivalent experience.

EXPERIENCE
Minimum of 12 years + of experience in pharmaceutical industry and related capital
project management.
Experience working in cGMP biotech environment.
Demonstrate ability to execute projects on time and on budget.
Ability to manage multiple disciplined technical staff.
Proficiency with standard office software applications, including MS Word, MS Excel,
MS Project, MS Power Point, MS Access.
Strong organization, interpersonal, oral and written communication skills.
Strong leadership skills
Ability to balance competing interests such as, project and corporate goals
Outgoing with the ability to resolve issues and manage tasks to completion
Must have excellent verbal and written communication skills, excellent conflict
resolution and people interface skills.
Experience with Oracle Primavera (P6, OPPM, etc.) a plus
PMI certification a plus

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law.

In the U.S., the salary range for this position is $ 172,000 to $ 258,000 per year, which factors in various geographic regions. The base pay actually offered will take into account internal equity and also may vary depending on the candidate's geographic region, job-related knowledge, skills, and experience among other factors. A discretionary bonus and/or long-term incentive units may be provided as part of the compensation package, in addition to the full range of medical, financial, and/or other benefits, dependent on the level and position offered.

Description

Who We Are

It takes a village, and at BioMarin our corporate groups are the people behind our success. Groups such as IT, Finance, Legal, Global Compliance & Ethics, and our People Team provide foundational support of all areas of operation at BioMarin.

International Contract Associate, Legal Department

The Contract Management team of the International Legal Department has responsibility for the management of contracts for the departments and regional teams in the companys organisation located in Europe, Asia Pacific, Latin America and Middle East. The purpose of this position of Contract Associate, based in Dublin, is to support the management of the day-to-day contracting requirements of all the Legal departments internal clients and ensure the smooth and swift delivery of contracts to them.  It will also involve liaison with BioMarins Legal Department located in the United States.

We are a high-performing, team-based organization, where colleagues are flexible, multi-skilled and empowered to make decisions.   A high level of initiative, energy and motivation are key role requirements, as well as organisational skills.

RESPONSIBILITIES

• Draft, prepare and organise all assigned contracts in the legal system and work closely with colleagues to turn around and deliver support and contracts to the relevant internal stakeholders.
• Support the development, implementation and maintenance of legal policies, advice and training.
• Assist with the implementation and running of the legal IT systems, processes and ensure training provided to clients where necessary.
• Assist with drafting and organisation of corporate documents.
• Maintain current understanding of laws and regulations, industry trends and changes applicable to pharmaceutical/biotechnology compliance in the EUMEA region.
• Coordinate project management of various legal-related activities and initiatives.
• Other ad hoc duties as may be reasonably required by the business.

EDUCATION

• Have qualified with an Honours Degree at a minimum. Law degree a plus.

EXPERIENCE

• A minimum of 3 years legal in-house experience. Experience at a pharmaceutical/biotechnology organization strongly preferred. Law firm experience a plus.
• Demonstrated knowledge and understanding of the pressures on in-house legal departments and use of IT systems to process and organise contracts.
• Demonstrated knowledge and understanding of the legal and regulatory framework affecting the pharmaceutical/biotechnology industry in Europe.
• A sound knowledge of Irish law as it relates to contracts and companies.
• Demonstrated effectiveness operating in complex organizational and regulatory environments.
• Excellent written, oral and presentation skills.
• A high level of administrative skills excellent knowledge of all Microsoft office applications
• Proven ability to work with all levels of organizations.
• Strong problem-solving skills.
• Strong customer service focus, excellent organizational skills and proven time management skills.
• Very strong interpersonal and communication skills and a strong ability to work in a team environment.
• Demonstrated ability to partner effectively with others in addressing complex issues.
• Strong persuasive and influencing skills and sound business judgment.
• Strong task-focused work ethic with a demonstrated ability to work to and meet tight deadlines and commitments.
• Demonstrated flexible approach to adapt to changing in business needs, as they arise. This requires the ability to be flexible in managing own workload and in supporting the workload of the team which may require you to work in a new style for periods to support projects.
• Proven self-motivation, a self-starter with the ability to appropriately prioritize issues, allocate resources and multi-task
• Demonstration of being capable of working on own initiative without regular supervision.

EQUIPMENT

Laptop and cell phone

CONTACTS

Deputy General Counsel, Head of International Legal Department;

Associate Director, Head of International Contract Management;

Contract Associates in the International and US Legal teams;

Corporate Counsel, Legal Department International.

This position will interact and work closely with colleagues from all departments throughout the organization

Note: This description is not intended to be all-inclusive or a limitation of the duties of the position.  It is intended to describe the general nature of the job that may include other duties as assumed or assigned.

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law.