Description

The Position

Role Summary:

The Principal Health Economist should have strong technical expertise in Health Economics and Outcomes Research (HEOR). H/She should be able to independently develop an HEOR strategic plan and conduct HEOR research projects including economic modeling, real world data research and patient-reported outcomes research. This individual should be able to engage and manage outside vendors and/or work collaboratively with internal data scientists from the technical institute to conduct HEOR to support one or more disease areas or molecules, and present results at internal meetings or external conferences. H/She should be able to identify and develop relationships with external customers and therapeutic area experts.

Qualifications

Masters +/- PharmD, Doctoral Degree

8+ years of industry experience

Key Accountabilities

• Ensuring assigned goals and objectives are met and that assigned projects and other work are completed on time, to high standards and within budget

• Able to appropriately select and manage vendors and resources, including submission of information for contracting and other internal processes and making sure projects are completed within timeline and allocated budget.

• Develop, build and maintain internal and external collaborative relationships. Able to work collaboratively internally with data scientists, medical, commercial and field colleagues. Individual must be able to engage collaboratively with customers, therapeutic area experts and HEOR experts.

• Able to own their own professional development and identify opportunities to develop leadership and technical skills. Demonstrated ability to keep abreast of new methods and advancements in the field of HEOR and Health Services Research.

• Comply with all company policies and regulations.

Responsibilities

• Demonstrated ability to independently develop an HEOR strategic plan and associated tactics across all phases of a product's lifecycle.

• Able to independently execute HEOR projects with no supervision.

• Individual is able to proactively identify opportunities for HEOR research and successfully pull through the evidence generated through HEOR projects into publications and other promotional or reactive materials. Individual should be able to present and discuss HEOR project methods and findings to a diverse audience.

• Has broad and diverse therapeutic area knowledge and expertise and is able to identify experts in the HEOR area for specific disease areas.

• Able to participate in cross-functional initiatives to represent E4A.

Core Competencies

• Trusts and empowers team members to deliver results; balances appropriately between delegation and support.

• Navigates effortlessly and appropriately between tactical details and strategic, long-term considerations.

• Consistent track record of encouraging others to prioritize and support organizational needs before individual or team needs.

• Finds ways to individually and/or publicly recognize the efforts and commitment of team members.

• Shapes the perspectives and positions of key internal stakeholders and decision-makers related to medical and scientific points of view.

• Conveys confidence and leadership presence when communicating with audiences of all levels.

• Advances bold ideas for exponential improvements, even when faced with initial resistance.

• Actively expands breadth and depth of expertise in medical activities and is a recognized expert.

While we may consider applicants for remote work within the continental U.S., preference will be given to applicants who either reside in the Bay Area, or are willing to relocate to the Bay Area.

Comprehensive relocation assistance will be provided.

The expected salary range for this position based on the primary location of California is $158K and $329K.  Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law.  A discretionary annual bonus may be available based on individual and Company performance.  This position also qualifies for the benefits detailed at the link provided below.

Genentech is an equal opportunity employer, and we embrace the increasingly diverse world around us. Genentech prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin or ancestry, age, disability, marital status and veteran status.

Description

The Position

Genentech is an equal opportunity employer, and we embrace the increasingly diverse world around us. Genentech prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin or ancestry, age, disability, marital status and veteran status.

Description

The Position

Who We Are

US Commercial, Medical, and Government Affairs (CMG) is the US market and customer-facing unit of Genentech and a critical element of the broader Roche Pharmaceuticals business. To optimally deliver on its mission to deliver more life to all patients today and fuel tomorrows breakthroughs, CMG must interface with Roche Pharma and Roche Group affiliates on longer-term (3-5 years) pipeline, disease area and personalized healthcare strategic opportunities.

The Vice President, New Product Commercialization is a leadership position accountable for setting the direction for people in CMG working on pipeline assets, disease area strategy with oncology & neuroscience shared customers, and personalized healthcare. The sub-organization in commercial portfolio works closely with the following stakeholders to clearly define remit & impact:

• Squad, marketing & medical leadership on pipeline assets (both internal assets and through partnering)

• Squad Leadership on disease area strategy with shared customers in oncology & neurology

• Roche Diagnostics, FMI, Flatiron, GPS/PD leadership on CMG personalized health care strategy & execution

The individual will also lead the employees in this team with high engagement, and ensure excellent coaching and advocacy for their work to ensure a great employee experience. This role reports to the SVP of Commercial Portfolio.

Key Duties and Responsibilities: Pipeline and Partnering

• Continuously advance operational excellence in building the strategic & executional bridge between pipeline assets & in-licensing assets to commercialized assets by leading the pipeline team across the portfolio.

• Discern key external trends & internal patterns across portfolio that are enabling and hampering the competitiveness of CMGs future commercial portfolio; introduce change as needed

• Actively collaborate with Pharma Partnering and GPS to provide US POV on late stage partnering opportunities

• Play the role of US Squad Lead for disease areas that are new to Roche/Genentech

Disease Area Strategy and Execution

• Understanding how to build differentiated value propositions across stronghold disease areas to advance our competitiveness as an oncology and neuroscience company.

• Spearhead deeper insight about shared set of customers & driving experiments to deliver value across Squad, CE and Functional operating model 

Personalized Healthcare

• Accountable for the strategic planning capability for PHC across the CMG organization

• Play an important, catalyzing role in Roche Group strategic alignment (FMI, Flatiron, Roche Diagnostics, PHC GPS/PD) in the US market to optimize PHC today and PHC tomorrow

• Provide strategic guidance on PHC vision and provide US POV in deployment of digital solutions

Long Term CMG Enterprise Strategy

• Contribute directly to long-term CMG enterprise strategy as commissioned by USLT

• Partner across CMG to evaluate key external trends and make recommendations to shape the future GTM approach or evaluate new models of commercialization

Capabilities:

• Systems thinker who sees interdependencies and implications, and solves for the whole

• Demonstrated ability to serve as a connector and catalyst driving impact through strategy

• Strong coach and developer of people

• Demonstrated ability to leverage digital & analytics (AI/ML) tools & application to above Squad disease strategies & PHC

• Ability to coherently set and pull through strategy across various points of Roche/Genentech value chain including drug development, in market with commercial products, and integrated solutions (Dx, Rx, data solutions)

• Clear and effective communicator

• Influential with senior executives, senior leader peers, and the broader enterprise

• Collaborative leadership style and builds bridges across functions within the broader organization

• Understanding of PHC ambition and Roche Group capabilities

• Experience commercializing NMEs and building GTM approaches in different therapy areas

Required Qualifications and Experience:

• Bachelors Degree required. Advanced degree preferred (MA/MS/MBA/MPh)

• Twelve + years of work experience

• Experience in leading collaboration across large cross-functional teams

• Experience working closely on pipeline asset(s) evaluation & commercialization readiness with GPS/LCT colleagues

• Depth in TA level go-to-market strategy spanning at least 2 or more Genentech TAs (Oncology, I2O, Neuroscience & rare diseases)

• Customer-facing experience in US Market across HCPs, payers, and patients

• Strong executive presence and leadership, while also uncovering opportunities and challenges at the team level architecting new operating models to increase impact of focus areas -- pipeline, partnering, digital solutions & above squad TA strategy.

• Business travel is required to support business needs

Our Operating Principles

• Put Patients First: I always act as if patients I know are in the room and do what's best for them.

• Follow the science: I seek answers through experiments, data and debate, and act on facts. 

• Act as one team: I care, collaborate and commit without boundaries, and trust others to do their part.

• Embrace differences: I seek diverse perspectives, invite opposing views, and challenge myself and others.

• Accelerate learning: I push to learn new things even if difficult, and openly share my successes and failures.

• Simplify radically: I eliminate complexity, reuse with pride, and accomplish more with less. 

• Make impact now: I take accountability to do what's right, deliver value fast, and don't wait for certainty.

• Think long term: I choose actions today that benefit future generations.

Location

• This position is based in South San Francisco, CA

• Relocation assistance is being provided

The expected salary range for this position based on the primary location of South San Francisco, CA is $252,000 - $468,000. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law.  A discretionary annual bonus may be available based on individual and Company performance.  This position also qualifies for benefits.

Genentech is an equal opportunity employer, and we embrace the increasingly diverse world around us. Genentech prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin or ancestry, age, disability, marital status and veteran status.

Description

The Position

Product Manager - CRF Data Acquisition and Ingestion

Job Posting Description

The CRF Data Acquisition and Ingestion Product enables the capabilities of capturing CRF data from potentially several source systems and processing it into standardized/harmonized entities for consumption by downstream processes/solutions and a broad group of stakeholders. It is an exciting area with significant potential to innovate by reimagining the future of clinical data capture, for example, directly from EHR/EMR systems.

It offers the opportunity to collaborate across the Roche research organizations, Flatiron and with colleagues from the Diagnostic division to put together an end to end strategy ensuring we invest in our clinical trial data pipelines in a manner that maximizes the value of clinical data for Roche and simplifies the experience for site staff and Patients.

Mission

As a Product Manager you will be accountable for product(s) vision, strategy, roadmap and end-to-end product lifecycle. You will promote a strong focus on Product Management including networked, agile ways of working and role model business partnering closely collaborating with stakeholders, Domain Leads and Product Line Leads to shape the digital strategy, roadmaps and portfolios and co-create solutions to maximize the value delivered by the agile teams within your product(s) area. 

What you'll be working on

Youll be working within the PDALM Domain and Product Data Enablement Product Line. Product Data Enablement focuses on the acquisition and ingestion of clinical data (CRF, non-CRF, bioSample & digital Biomarker) with a focus on efficiency and quality. It also has a focus on the processing of data and access to bioSamples for secondary use.

The CRF Data Acquisition and Ingestion product enables the capabilities of capturing CRF data from potentially several source systems and processing it into standardized/harmonized entities for consumption by downstream processes/solutions and a broad group of stakeholders.

STAKEHOLDER MANAGEMENT AND PARTNERING

• Deeply connect and understand the customer and business needs and closely partner with stakeholders (and business process management where applicable) to develop the strategic direction of the product and shape the digital roadmap and portfolio to quickly deliver highest value outcomes for Patients, Society and Roche

• Drive co-creation of product vision and strategy, including contribution to the development and implementation of cross Products and Product Line strategies, through deep partnership and collaboration with products stakeholders

• Define and deliver the product roadmap and manage the end-to-end product lifecycle (including continuously facilitating product discovery), ensuring it delivers tangible and meaningful value aligned with customer needs and expected business outcomes, overarching Product Line strategy and Enterprise Architecture and Sustainability principles to enable the Business to leverage the full Informatics offering

LEADERSHIP AND INFLUENCE

• Lead, manage and mobilize agile product teams. Lead and influence in a matrix environment; create an environment of teamwork and partnering within the area and across business organizations and Informatics

• Work closely with Product Line Leads and Chapters to ensure the workforce strategy supports the future product needs and that the product fosters agile working

• Ensure security, quality and privacy practices are embedded into product lifecycle in alignment with the global Information Security Management System

• Coordinate, connect and collaborate across informatics to foster a spirit of "One Roche"

IMPACT AND COMPLEXITY

• Support Product Line Lead in portfolio prioritization; lead strategic planning for the product and collaborate with other Product Managers and the Product Line Lead for the definition of end-to-end service levels, monitoring of KPIs and OKRs

• Accountable for the total cost of your product, including budgeting and financial management

• Define and manage product service levels, governance and operational support model(s) aligned with stakeholder needs

• Lead or coordinate technical discussions and vendor negotiations

• Ensure stability, quality and transparency in all aspects of the product governance and partner with senior/global leaders to ensure compliance with existing and changing regulations (e.g. Informatics Quality, Information Security, Finance)

Information Security, Privacy and Regulatory

• Demonstrate a working knowledge and implications of general and Roche-specific information security, privacy and regulatory principles and requirements.

• Accountable that product and services are designed, delivered and maintained in accordance with applicable information security, privacy and regulatory requirements. 

• Ensure information risk assessment process and implementation guidelines are followed.

What youll need to be successful

• 5+ years of leadership experience and related product-centric knowledge

• Bachelor or advanced degree  

• Exhibits servant and creative leadership (VACC) behavior-

• Exhibits a Lean-Agile Mindset and excels at Product Management practices 

• Takes 'progressive risk'--not thrill-seeking, but risk that leads to opportunity

• Has a keen IT market focus: you are passionate about major trends for the specific discipline

• Demonstrates an executive presence, strong business acumen, ability to navigate ambiguity, and manages complexity

• Has an enterprise mindset that can break down silos. Focus on continuous delivery through collaboration, and bringing people together to work towards the same purpose across organizational boundaries.

• Exhibits ability to empower teams and individuals to act autonomously and hold them accountable.

• Exhibits ability to manage and account for large product budgets

• Exhibits intellectual curiosity and integrity and has a strong passion for innovation

Locations

Primary Location:

South San Francisco.

Secondary Locations:

Mississauga, Canada/Indianapolis/Basel/Madrid/Penzberg/Petaling Jaya/Pleasanton, USA/Rotkreuz/Santa Clara/Shanghai/Singapore.

Travel - Minimized by leveraging virtual collaboration methods

This posting spans multiple global grades.

The expected salary range for this position based on the primary location of California is $115,920 and $215,280.  Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law.  A discretionary annual bonus may be available based on individual and Company performance.  This position also qualifies for the benefits detailed at the link provided below.

Genentech is an equal opportunity employer, and we embrace the increasingly diverse world around us. Genentech prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin or ancestry, age, disability, marital status and veteran status.

Genentech requires all new hires to be fully vaccinated against COVID-19 as of their start date. This requirement is a condition of employment at Genentech, and it applies regardless of whether the position is located at a Genentech campus or is fully remote.  If you are unable to receive the vaccine due to a disability or serious medical condition, or because it is prohibited as a result of your sincerely held religious beliefs, you will have an opportunity to request a reasonable accommodation.

Description

The Position

Please note the preferred location for this position is at our US biologics manufacturing site located in Oceanside CA or at our Genentech US headquarters South San Francisco CA

At Roche, 94,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, weve become one of the worlds leading research-focused healthcare groups. Our success is built on innovation, curiosity, and diversity. We believe every employee makes a difference. We are passionate about transforming patients lives. We are courageous in both decision and action; we believe that good business means a better world.

In June 2021, the Pharma Technical (PT) leadership team shared the PT Response to the Pharma Vision: Radical Simplification and Pioneering for Excellence. To realize the Pharma Vision, there is a need to master new technology and modalities. We will handle more batches, more value streams, and more suppliers which adds complexity to our work. This strategy will support us to remove that complexity and innovate along our journey of continuous improvement. Lean and Digital transformation are key enablers to reach our North Stars.The global Pharma Technical Operations (PT) organization has the mission of empowering the use of Advanced Analytics to drive its business decisions as a core part of the strategy. Advanced Analytics is going to be one of the key digital technologies and accelerating factors that support the deployment of our PT performance promises, such as Fast to Patient, Robust Processes and Efficient Processes.

Job Summary:

This role will have a broad strategic PT-wide influence and will design the according OCM strategy and oversee the implementation of the overall digital deployment strategy for US site related use cases, in close alignment with the PT strategy deployment leads. The person in this role will be in the leadership/ enabling team (LT/ET) of PTE, reporting to the Head of Digital, Analytics and Operational Excellence.

As a visionary, the incumbent will collaborate with teams across PT to define an execution plan for all US relevant digital roadmap aspects based on our PT Digital strategy and in alignment with the PT strategy deployment roadmap that will be executed PT-wide. As an architect, the incumbent will provide appropriate measures, processes and tools to best orchestrate the PT strategy deployment journey for our US use cases, and will ensure lasting change into new ways of working. As catalyst and coach, the digital strategy & value assurance lead supports cross functional teams in the sites & functions focused on the delivering of our Performance Promises (FAST, EFFICIENT, ROBUST)

The position is an enterprise-level role that connects across the organization and communicates broadly across all layers in the organization. The role requires deep experience in building a strong culture, a strong network of people across all levels of the organization, strategic thinking and business value orientation, and advanced influencing capabilities and VACC leadership skills.

Primary duties and responsibilities

1)  Be a delivery coach for the deployment of use cases in the US

Architect the US based delivery organization in alignment with the global strategy.

• Challenge the status quo, understand requirements for change in order to create new ways of working and deliver value, and design the required OCM strategy

• Build and lead a team of global product owners based in the US, who are responsible to execute a portfolio of digital use cases

• Build the structure and operating model of delivery teams for these US based use cases (consisting of product owners, data scientists & engineers, digital translators, SMEs, etc.)

• Define interfaces between US based delivery organization, factories, and other functions

• Act as catalyst for digitization by supporting communities of local and functional experts around defined prioritized themes, to review business needs, prioritize use case functionalities and ensure change adoption of new solutions for US based use cases.

• Engage external technology and knowledge partners in the development of PTs breakthrough and digital initiatives, and build ecosystem of innovative partners who support the creation of new high-impact use cases

 
Value catalyization and capture through use case development and deployment

• Coach delivery teams in:

• Development and deployment of digital use cases to maximize value capture, with strong focus on breakthrough initiative

• Identifying risks and defining mitigation plans

• Ensuring aligned and standardized delivery of use cases globally

• Implementing agile ways of working

• Identification and engagement of external partners

• Catalyze delivery by convening and engaging the relevant local and central stakeholders (Digital and OE) and by bringing-in leading technology partners and state-of-the-art knowhow

Strategy and roadmap

• Collaborate with local, functional and strategy teams to define roadmap and prioritize key initiatives for the US (aligned with strategic plan and vision)

• Coach and counsel local and functional organizations in identification and prioritization of lean and digital initiatives that support target achievement

• Participate in strategic process to define future north star and refinement of digital strategy

 
Knowledge sharing, capability-building and change management

• Facilitate sharing of knowledge and best practices across functions

• Support communication strategy of digital program, act as an ambassador of digital initiatives in internal communication

• Define skills requirements for delivery organization

• Ensure capability building needs related to use case delivery are embedded in capability-building program

2) Be the  Neighborhood Lead for PTE in the US

• Architect & govern the US Digital & OE neighborhood communities, create a common sense of belonging, ONE team spirit across all Digital & OE functions (e.g. PTx, IIT, RDI, pRed/gRed, etc.)

• Support the strategic workforce planning of PTE, talent management & flow across PTE, D&I roadmap, ORDP talent development with focus on Digital & OE roles, etc. with first focus on the US

3) Be the coach for services for established Digital products (e.g. digital products around data, capability building, etc.)

• Coach PTE teams for established Digital products to define clear sustainment processes and requirements

• Coordinate and orchestrate PTE chapters providing Digital services across (e.g. KM, AcademyX)

QUALIFICATIONS

Education

• BS Degree  (scientific/technical disciplines preferred).  Advanced degree (MS, MBA)  preferred.

Experience

• Strong demonstrated track record of leading change, and of enabling organizational transitions to align with changing business contexts.

• 15 plus years industry experience with a strong emphasis on digital deployment within pharmaceutical/biotech technical operations functions

• Ability to manage senior relationships across all PT and functional areas.

• Proven track record of innovation and transforming organizations as evidenced by products and organizational impact.

• Demonstrated technical and leadership skills and a history of successfully leading/governing strategic initiatives working cross functionally. Skilled in managing cross-functional stakeholder relationships in a complex organization

• Excellent people leadership capabilities with demonstrated skill in building, guiding and inspiring effective teams and fostering productive collaborations. Strong operational skills, with experience in managing budget and vendor relationships.

• Evidence of business and technology acumen.

• Highly developed, situationally appropriate written and oral communication skills.

• Effective advocate to senior management a diverse set of governance bodies.

• International/global experience is strongly preferred

• Collaborative team player orientation towards work relationships, strong culture awareness

• Demonstrated result orientation, ability to share direction to teams and drive operations to completion.

• Demonstrated ability to manage adversity and challenging situations.

• Highest personal and professional integrity and strong work ethics.

TRAVEL REQUIREMENTS

Ability to travel according to the needs of the position; domestic and international travel

The expected salary range for this position based on the primary location of Oceanside CA is $168,000 - $312,000.  Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance.  This position also qualifies for the benefits detailed at the link provided below.

Genentech is an equal opportunity employer, and we embrace the increasingly diverse world around us. Genentech prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin or ancestry, age, disability, marital status and veteran status.

Genentech requires all new hires to be fully vaccinated against COVID-19 as of their start date. This requirement is a condition of employment at Genentech, and it applies regardless of whether the position is located at a Genentech campus or is fully remote.  If you are unable to receive the vaccine due to a disability or serious medical condition, or because it is prohibited as a result of your sincerely held religious beliefs, you will have an opportunity to request a reasonable accommodation.

Description

The Position

Mission of external quality.

• We serve our patients through external partnerships because access to quality products is every patients right.
• We leverage external partners in order to offer flexibility to our internal capacity at the right cost and quality.
• We enable our external partners to reliably deliver compliant, quality products to our supply chain customers, so that we can deliver to patients worldwide.
• We do this through cross-functional collaborations ensuring quality process excellence and continuous improvement.

Main Purpose of the Position

• Provide quality and compliance oversight for external GxP suppliers including CMO, CLO, suppliers or distributors of direct materials or critical process-contacting spare parts, suppliers for analytical equipment or manufacturing systems, and service providers to ensure compliance with cGMP and quality agreement requirements.
• Serve as the Quality Point of Contact (PoC) for designated suppliers and participate as a key member of GxP supplier cross-functional management teams to enable (as applicable for the supplier lifecycle stage) site selection and implementation (including due diligence activities), ongoing quality supply of commercial products, materials or services from suppliers, and decommissioning.

Technical Job Responsibilities

• Oversee all required quality activities during the lifecycle of a GxP supplier (Source & Select, Implement, Manage, and Decommission), including but not limited to: process or method validations, Roche and Health Authority audits, complex investigations, market complaints, and regulatory submissions.
• Develop, negotiate and maintain risk-based Quality Agreements and Product Specific Requirements (as appropriate) with GxP suppliers and ensure compliance with agreements.
• Collaborate with GxP suppliers to address gaps of audit responsiveness, CAPA implementation, deviation reporting and management, complaint management, investigation closure, and change implementation with regard to quality and time with the supplier; and escalate as appropriate.
• As applicable, manage all required activities to support Make Assess Release (MAR) of commercial medicinal products including approval of master process documentation, resolution of investigations, assessment of changes, and monitor and report GxP Supplier quality performance.
• As applicable, release, reject or quarantine commercial medicinal products (drug substance or API, bulk drug product, and semi-finished and finished products) and medical devices produced within the area of responsibility per applicable Swissmedic and Roche requirements on behalf of the Responsible Person (RP).
• As applicable, collaborate with GxP suppliers to  maintain the manufacturing processes and the Specifications and Analytical Methods (SAM) in a validated state and compliant with the regulatory dossier, including stability testing programs.
• As applicable, develop and maintain quality risk management plans; utilize risk management tools to identify and mitigate supplier quality and compliance risks, ensuring suppliers are in a state of continuous inspection readiness.
• As applicable, manage or lead technical transfers for manufacturing, testing, packaging, and product launches.
• As applicable, support or lead supplier improvement initiatives to solve complex manufacturing or quality problems. Identify, design and implement process and system improvements
• Functional Job Responsibilities
• Collaborate and manage relationships across supplier management and internal cross-functional  teams to ensure quality expectations are aligned with Roche objectives.
• Notify Senior Management of potential quality or regulatory issues that may impact product quality or regulatory compliance.
• Troubleshoot and drive the resolution of quality issues, fostering effective interdepartmental and cross-functional partnerships.
• Sign documents as authorized and described by Roche policies, procedures and job descriptions.
• Be accountable for behaviors described in Roches Code of Conduct.
• Deliver business outcomes in support of departmental objectives.
• Maintain and communicate work priorities to meet goals and timelines.
• Timely complete all job-related training requirements prior to performing GMP-job functions and strive to continuously improve on knowledge and skills in quality, compliance and technology.
• Communicate new and updated regulatory requirements and applicable Roche expectations to GxP suppliers as applicable, and evaluate systems in place.
• Perform other quality related activities and projects in order to ensure quality and compliance and enable continuous improvement.
• Identify, support and/or lead continuous improvement initiatives that may benefit External Quality and other organizations.
• As applicable, deputize for the GxP Supplier Management Chapter Lead or a peer and assist with their duties if and when required.
• May mentor and/or coach colleagues within and outside the organization.

Minimum Qualifications and Skills

• B.A. or B.S. degree in life sciences or equivalent
• 8-10 years of experience in the pharmaceutical or related industry. Experience with quality management of GxP service providers is a plus.
• Sound knowledge of cGMP, ISO standards and international regulations for pharmaceuticals. Ability to interpret quality standards as they relate to GxP suppliers.
• Proven ability to influence across cultures and functional reporting lines, and to drive continuous improvement initiatives
• Demonstrate agile mindset and behavior.
• Highly competent in MS office or Google Suite applications including Excel, Powerpoint, Word, and MS Project, etc.
• Ability to communicate clearly and professionally both in writing and verbally.
• Fluency in oral and written English is a must. Additional language skills are a plus.
• This position may require up to 10% domestic and/or international travel.

Relocation is not available for this position.

Employee must be located near one of the Genentech sites listed. Candidates local to Oceanside preferred.

The expected salary range for this position based on the primary location of Oceanside, CA is $137,700 and $239,700.Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law.  A discretionary annual bonus may be available based on individual and Company performance.  This position also qualifies for the benefits detailed at the link provided below.

Genentech is an equal opportunity employer, and we embrace the increasingly diverse world around us. Genentech prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin or ancestry, age, disability, marital status and veteran status.

Genentech requires all new hires to be fully vaccinated against COVID-19 as of their start date. This requirement is a condition of employment at Genentech, and it applies regardless of whether the position is located at a Genentech campus or is fully remote.  If you are unable to receive the vaccine due to a disability or serious medical condition, or because it is prohibited as a result of your sincerely held religious beliefs, you will have an opportunity to request a reasonable accommodation.

Description

The Position

 Key Responsibilities

• Deliver 1:1 career development to employees in alignment with Genentech and Roche values

  • 1:1 career coaching sessions with Individual Contributors, People Leaders

• Create, facilitate and deliver intact career development and team building content to GNE teams working with directly with the client

• Goal-oriented team leader who is results-driven, proactive and has a strong work ethic

• Determines training needs for Career Lab consultants and creates training plans

• Provide a welcoming and enthusiastic environment to new hires by facilitating New Hire Orientation as a backup

• Attend Welcome to Genentech team meetings and trainings to stay up to date

• Seeks out the knowledge about GNE and Roche resources to ensure that clients are aware of  programs and services (seen as an expert)

• Work within our online scheduling database to capture client notes and records

• Creates an connections with clients based on dignity, inclusiveness and respect

• Passion for delivering quality service that exceeds expectations

• Strong communication, facilitation, instructional design  and presentation skills 

• Able to balance employee needs with the needs of the business

• Able to review data and draw conclusions to enhance programming 

• Keeps up to date on People Experience trends for career development and new hire experience (passion for learning)

• Ability to work with internal staff to generate online career resources that support and align with Genentech and Roche operating principles and philosophies (Create and manage on demand content to support employee development)

• Comfortable flexing between roles and projects within the People Experience team as it relates to Career Development and New Hire Experience

• Partner with our HR Business Partners, Talent Partners, Roche Career Center and People Experience team to develop career development strategies that support key business needs or initiatives.

• Provide leadership, mentorship and support for career development consultants in the Career Lab

• Able to incorporate Roche Operating and Leadership principles into career coaching and coach other career lab consultants 

• Partner with diversity teams to integrate key concepts of equity, ally-ship, inclusion, and diversity into career development coaching

• Accountable to ensure career development training and materials are up to date

• Determine the catalog of curated content from the Roche catalog 

• Collect, analyses and creates new programming based on employees career development needs

• Effectively prioritizes and solve complex problems while making decisions for how the Career Lab addresses the changing needs of our employees and our business
   

Skills

• Certification or training or education in career development, and/or career counseling/coaching experience preferred

• Certification in various assessments, ex: MBTI, Enneagram, StrengthsFinder, Strong Interest, etc.

• Quick adaptability to change

• Self-starter

• Creative thinker

• Excellent networking skills
   

Experience & Education

• 8+ years in the field of Human Resources, People Experience Coaching, Career Development and/or Counseling

• Certified coaching professional required and 3+ years of coaching experience

• Bachelors degree in related field required, Masters degree in related field preferred
   

Travel

5-10% travel for intact team session facilitation  

Relocation benefits are not available for this job posting

The expected salary range for this position based on the primary location of California is $135,870 - $252,330. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law.  A discretionary annual bonus may be available based on individual and Company performance.  This position also qualifies for the benefits detailed at the link provided below.

Genentech is an equal opportunity employer, and we embrace the increasingly diverse world around us. Genentech prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin or ancestry, age, disability, marital status and veteran status.

Genentech requires all new hires to be fully vaccinated against COVID-19 as of their start date. This requirement is a condition of employment at Genentech, and it applies regardless of whether the position is located at a Genentech campus or is fully remote.  If you are unable to receive the vaccine due to a disability or serious medical condition, or because it is prohibited as a result of your sincerely held religious beliefs, you will have an opportunity to request a reasonable accommodation.

Description

The Position

The Position

Our group is searching for an experienced and dynamic Device Development Principal Engineer to be responsible for developing innovative drug delivery devices designed for Genentechs next-generation drug pipeline.

Using state-of-the-art technology, the successful candidate will lead the development of combination products to enable clinical and commercial production in our network worldwide - in collaboration with Genentech's scientific, quality and manufacturing organizations. She/he will be working on the creation of leading-edge drug delivery devices, often in collaboration with our development partners worldwide, creating solutions to meet the highest standards for quality and reliability.

It is expected that the candidate will take a lead position in projects on mechanical and electro-mechanical system design. The candidate will lead a cross-functional technical team during the project planning and execution.

We are looking for an outstanding candidate that is creative, self-motivated, able to deal with uncertainty and perform with grace under pressure. The environment is on the forefront of medical innovation, with technology and scientific challenges, results oriented, and rewarding for high-potential individuals.

Job Responsibilities

• The candidate will work with his/her team to ensure that device design, component selection, manufacturability and test methods meet patients needs. This person will contribute significantly to design controls documents, test plans and test execution.
• Use state of the art engineering and process tools, such CAD, FEM, tolerance, functional and stress analysis on parts and entire systems to improve the way we design and test devices.
• Lead and execute the mechanical/electro-mechanical system and part design from specification development up to transfer to manufacturing including fabrication, testing, verification and validation of engineering prototypes;
• Link manufacturability, Statistical Process Control and design to Risk Analysis and Design Input Requirements;
• Analyze and extract insight from complex body of data, lead Root Cause Analysis in the Device team;
• Define new mechanical product architecture, analyse and verify performance and perform feasibility studies;
• Work in cross-functional teams with Engineering, Sourcing, Quality and Operations;
• Guide the work of junior engineers and of our external development partners.

Job Requirements/Qualifications:

• BSME (or equivalent) with 8+ (14+ for Sr. Principal Engineer) years of experience in development and design of medical devices (combination products a plus).
• Mechanism design, analysis and theoretic modelling of mechanical and/or electro mechanical systems.
• Demonstrated excellent technical writing skills.
• Excellent knowledge of statistical analysis and tools to conduct it.
• DFx, manufacturing, assembly, test, reliability and cost
• Tolerance analysis
• 3D CAD modelling, experience with Solidworks is a plus
• Failure and root cause analysis
• FMEA
• Able to lead project feasibility tasks, where product specifications are not defined yet and subject to changes
• FEA for advanced structural, kinematics, thermal analysis using Pro/MECHANICA, ABAQUS or ANSYS is a plus
• ESD and EMI design rules and principles is a plus
• Domestic travel of 20% annually can be anticipated

Relocation benefits are available for this position.

The expected salary range for this position based on the primary location of South San Francisco, California is $115,900 - $215,300. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law.  A discretionary annual bonus may be available based on individual and Company performance.  This position also qualifies for the benefits detailed at the link provided below.

Genentech is an equal opportunity employer, and we embrace the increasingly diverse world around us. Genentech prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin or ancestry, age, disability, marital status and veteran status.

Genentech requires all new hires to be fully vaccinated against COVID-19 as of their start date. This requirement is a condition of employment at Genentech, and it applies regardless of whether the position is located at a Genentech campus or is fully remote.  If you are unable to receive the vaccine due to a disability or serious medical condition, or because it is prohibited as a result of your sincerely held religious beliefs, you will have an opportunity to request a reasonable accommodation.

Description

The Position

 2024 Summer Intern - Finance Summer Associate

Department Summary

The Genentech MBA Internship Program is an intensive 12 week opportunity that provides work within a fast-paced and challenging environment. MBA interns contribute to meaningful projects, interacting and working side-by-side with biotech industry experts. Our internship program also provides a robust speaker series, which allows interns to hear from top executives throughout the summer. Genentech Finance relies heavily on our internship talent pool to fill full-time Finance positions, including rotational opportunities within the Global Finance organization. Applicants should have a long term interest and commitment to a career at Genentech/Roche.

This internship position is located in South San Francisco, on site.

Key Responsibilities

• Financial analysis support of key Finance processes (Budgeting, forecasting, business planning, investment valuations)

• R&D project portfolio financial planning (prioritization, risk analysis, etc.)

• Biopharma program valuation

• Sales force/marketing and distribution costs benchmarking, efficiency analysis and optimization

• Production cost driver and manufacturing network optimization

Program Highlights

•  Intensive 12-weeks, full time (40 hours per week) paid internship.

• Program start dates are in May and June 2024.

• Ownership of challenging and impactful business-critical projects.

• Work with some of the most talented people in the biotechnology industry.

• Final presentations of project work to senior leaders.

• Lead or participate in intern committees to design and coordinate program events and initiatives.

• Professional & personal development curriculum throughout the program, including networking opportunities, workshops, and panel discussions.

• Participate in volunteer projects, social events, and team-building activities. 

Who You Are

• Current MBA Student with the desire to work at an industry leading and cutting-edge Biotech

• Diverse experiences that can contribute new and fresh perspectives in an ever-changing landscape 

• Strong technical, quantitative and analytical skills

• Excellent communication skills with demonstrated ability to interact at all levels of the organization with executives and senior leaders

• Demonstrated collaboration and teamwork experience

• Drive to consistently deliver results and excel 

Other Qualifications

• Excellent communication, collaboration, and interpersonal skills.

• Complements our culture and the standards that guide our daily behavior & decisions: Integrity, Courage, and Passion.

Along with the submission of your CV, a cover letter is optional.

Relocation benefits are not available for this job posting. 

The expected salary range for this position based on the primary location for this position of California is $21.00 - $50.00 per hour.  Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. This position also qualifies for paid holiday time off benefits.  

Genentech is an equal opportunity employer, and we embrace the increasingly diverse world around us. Genentech prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin or ancestry, age, disability, marital status and veteran status.

Genentech requires all new hires to be fully vaccinated against COVID-19 as of their start date. This requirement is a condition of employment at Genentech, and it applies regardless of whether the position is located at a Genentech campus or is fully remote.  If you are unable to receive the vaccine due to a disability or serious medical condition, or because it is prohibited as a result of your sincerely held religious beliefs, you will have an opportunity to request a reasonable accommodation.

Description

The Position

Description
Genentech's Device Development team is searching for a Validation Engineer to assist, lead, and execute validation activities (e.g., equipment qualification, computer system validation) and manage discrepancies and changes to Qualified/Validated systems.

The candidate should have knowledge in Laboratory equipment qualification & validation process, data integrity (CFR Part 11 Compliance) implementation, cGMP documentation, Change Management, and operational maintenance of Laboratory equipment.

Responsibilities
The Validation Engineer will work in the Laboratory Operations group and collaborate across functions (e.g., quality, IT, and vendors) to lead, assist, and execute validation activities (e.g., equipment qualification, computer system validation).

This objective will be accomplished by executing the following activities:

• Coordinate and execute commissioning and qualification of laboratory equipment and computer systems (e.g., hardware, software, and accessory systems) for use in regulated and non-regulated operations.
• Author/ review commissioning and qualification documents throughout system life cycle. This includes deliverables such as user requirements, functional/design specifications, qualification protocol/report, and support documentation (e.g., IQ, OQ, PQ, traceability matrices, SOP, maintenance plan)
• Execute system periodic reviews.
• Initiate and manage discrepancy and change management process.
• Regularly interact with external development partners and equipment suppliers, Quality, and IT group.

General

• Understand, implement and maintain Roche Pharma Quality Policy and Pharma Quality System (PQS) in the department.
• Use (and create and implement, if necessary) local procedures and templates ensuring alignment with current versions of PQS documents and best practices.
• Support the team lead in preparing communications for internal review committees.
• Assist with resolving issues arisen from internal quality assessments/audits, regulatory inspections and notified body interactions, and aid in driving closure of inspection issues by preparing appropriate responses and corrective action resolutions.
• Create and review discrepancy, change/risk management documents as appropriate.
• Ensure compliance of training to PQS and job-related requirements.
• Utilize electronic document archive system and collaborate with Records Management team to ensure document compliance with PQS standards.
• Employ good document practices (GDP) when recording data, performing qualification/validation activities, maintaining archives and drafting and reviewing documents.

Skills

• Knowledge/experience of Computer System Validation (CSV) requirements and procedures for lab instrumentation and instrument qualification (IQ/OQ/PQ)
• Ability to work in a team, highly organized, detail oriented, work independently, and manage project priorities
• Excellent oral and written communication skills
• Knowledge of cGMPs or equivalent regulations
• Ability to understand and independently apply cGMPs and /or GLPs to everyday work with regard to documentation and laboratory equipment
• Experience in computer system validation is a plus.
• Knowledge of biopharmaceutical regulations such as FDA, cGMP, and 21 CFR Part 11.
   

Education / Requirements

• B.S. degree in Science or Engineering and at least 1-2 years of experience in the pharmaceutical or biopharmaceutical industry.
• Onsite availability for work required. At minimum 3 days per week or as requested by the team lead.

The pay rate range for this role is $58.05/hr -$75.19/hr.

Genentech is an equal opportunity employer, and we embrace the increasingly diverse world around us. Genentech prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin or ancestry, age, disability, marital status and veteran status.

Genentech requires all new hires to be fully vaccinated against COVID-19 as of their start date. This requirement is a condition of employment at Genentech, and it applies regardless of whether the position is located at a Genentech campus or is fully remote.  If you are unable to receive the vaccine due to a disability or serious medical condition, or because it is prohibited as a result of your sincerely held religious beliefs, you will have an opportunity to request a reasonable accommodation.