Executive Director, Analytical Development Pivotal & Commercial Biologics
United States - California - Oceanside
Gilead Sciences, Inc. is a research-based bio-pharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gilead’s therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.Making an impact on a global scale
Inclusion is one of the company’s five core values. That’s because we know that we are stronger and more innovative at Gilead when we are informed by a diverse set of backgrounds, experiences and points of view. Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide.
When you join Gilead, you join our mission to change the world by enabling people to live healthier and more fulfilling lives. Come join a mission-driven bio-pharmaceutical organization that values inclusion and diversity, has a strong portfolio of products, and is constantly #CreatingPossibleFor Current Gilead Employees and Contractors:
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At Gilead we believe every employee deserves a great leader. As a people leader now or in the future, we expect that you will model and create an environment of inclusion, be intentionally focused on the hiring, development, growth and retention of talent, and empower teams to align and achieve goals.
The Executive Director of Analytical Development (AD) will spearhead the analytical development encompassing method development, qualification, and molecule characterization for all biologics programs during the Pivotal and Commercial phases. They will play an instrumental role in post-launch Life Cycle Management (LCM) and will be an integral member of the Pivotal/Commercial Biologics Technical Development Leadership Team. This team oversees late-stage process development activities, including Cell Culture, Purification, Formulation & Process Development, Analytical Development, MSAT, and Materials Sciences.Responsibilities
- Provide leadership to the Pivotal & Commercial Biologics Analytical Development team.
- Accountable for:
- Methods: Including development, transfer, QC support, validation, remediation, and LCM.
- Reference standard, IPC and specification, comparability, and stability strategies.
- Analytical control strategies and regulatory strategies for drug substance and drug product quality attributes.
- Analytical target profiles, including method criteria
- Molecule characterization to define CQAs and develop phase appropriate QTPP targets for DS & DP development.
- Analytical testing for DS & DP development.
- Guide the draft, review, and approval of CMC sections in regulatory filings, and support agency interactions and inspections.
- Collaborate across Gilead Pharmaceutical Development & Manufacturing (PDM) and partner with Quality, Supply Chain, Manufacturing, CMC Regulatory Affairs, Finance and Technical Development to ensure timely delivery and successful commercialization of late-stage portfolio.
- Foster robust relationships with functions like Research, Clinical Development, and Product Strategy Teams while proving technical and strategic input.
- Exhibit comprehensive knowledge of cGMP practices and requirements.
- Act as a key member of the Biologics Technical Development Leadership Team to shape late-stage Biologics strategy.
- Pioneer the adoption of novel process technologies.
- Stay updated on Biopharmaceutical industry trends.
- Set organizational goals that align with broader objectives, balancing immediate and long-term priorities.
- Recruit, mentor, and nurture talent to cultivate a world-class Biologics AD organization.
- Oversee departmental budgeting.
People Leader Accountabilities
- A Ph.D. or M.S. in a relevant field with 15+ years in analytical development, showcasing increasing responsibility and comprehensive experience managing programs from INDs to MAAs.
- Subject matter expert in:
- MOA for defining CQAs and QbD-based control strategies.
- Comprehensive product quality control strategies for biopharmaceutical processes.
- Development/Qualification/Validation of various assays, including Product purity, process related impurities, and cell-based potency.
- Product characterization techniques, including both biophysical and potency-based methods.
- High-throughput assay methodologies.
- Well acquainted with industry best practices, guidelines, and trends.
- Proven track record in drafting regulatory documentation of all stages, including IND, BLA and MAA filings.
- Effective team builder with proven leadership in a multidisciplinary setting.
- Outstanding communication, decision-making, and interpersonal skills.
- Demonstrated ability to influence and shape industry standards with a notable presence in the scientific community.
- The ideal candidate will exhibit qualities like collaboration, accountability, cross-functional influence, strategic vision, and executive presence.
Gilead Core Values
- Create Inclusion - knowing the business value of diverse teams, modelling inclusion, and embedding the value of diversity in the way they manage their teams.
- Develop Talent - understand the skills, experience, aspirations and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, develop, and realize their purpose.
- Empower Teams - connect the team to the organization by aligning goals, purpose, organizational objectives and holding to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem.
- Integrity (Doing What's Right)
- Inclusion (Encouraging Diversity)
- Teamwork (Working Together)
- Excellence (Being Your Best)
- Accountability (Taking Personal Responsibility)
As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact email@example.com
The salary range for this position is: $242,590.00 - $313,940.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*.
For additional benefits information, visit: https://www.gilead.com/careers/compensation-benefits-and-wellbeing
* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
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As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact ApplicantAccommodations@gilead.com
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For Current Gilead Employees and Contractors:
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