Executive Director, Biologics Analytical Operations

Executive Director, Biologics Analytical Operations
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 #CreatingPossible


Gilead Sciences, Inc. is a research-based biopharmaceutical company founded in 1987. Together we deliver life-saving therapies to patients in need. With the commitment and drive you bring to the workplace every day, you will be part of a team that is changing the world and helping millions of people live healthier, more fulfilling lives. Our worldwide staff is a close community where you can see the tangible results of your contributions, where every individual matters, and everyone has a chance to enhance their skills through ongoing development. As part of our rapidly growing science-driven organization, colleagues at Gilead are revolutionizing healthcare by bringing urgently needed medicines to patients in the areas of HIV/AIDS, liver diseases, hematology and oncology, inflammation and respiratory diseases and cardiovascular conditions. We are proud to have some of the most talented colleagues from across the research, healthcare, pharmaceutical, biotechnology & business sectors, working together and supporting each other to help make a real difference to the lives of patients.

Executive Director, Biologics Analytical Operations

Role Description:

The Executive Director, Biologics Analytical Operations will be responsible for overseeing the development and execution of analytical test methods for therapeutic proteins from the research collaboration stage to commercialization. These test methods include GMP assays, assays to support process development, and extend characterization assays. The Executive Director will provide leadership to an organization responsible for Analytical Development, Extended Characterization, Potency Assay Development, and Quality Control. This position has the responsibility of coordinating the development and implementation of all test methods to ensure an effective and phase-appropriate control strategy and assessment of CQAs. The ideal candidate would have demonstrated leadership and knowledge with the development, validation, implementation and maintenance of biologic analytical methods. This position will work collaboratively with teams including Drug Substance Development, Drug Product Development, and Manufacturing within Biologics Development & Manufacturing organization, as well as Biology Research, Clinical Development, Quality Assurance, Regulatory Affairs, and Commercial teams of Gilead. The Biologics Analytical Operations team will work with external testing partners, to which this position provides oversight. The Executive Director will report to the VP Biologics Process Development.

Responsibilities:

• Provide leadership and direction to the Biologic Analytical Operations organization, a department of >60 scientists and associates
• Advance biologics candidates in pipeline by providing oversight, direction and decision with respect to analytical development and operations
• Establish and execute overall analytical lifecycle management strategy using the knowledge in process and product development and regulatory and compliance requirements
• Oversee development, validation, implementation, and execution of analytical methods in collaboration with internal and external stakeholders
• Establish analytical network strategy that utilizes QC laboratories including internal, CMO's, and contract testing labs for each product's lifecycle
• Evaluate and implement new technologies to drive innovation in biologics testing
• Drive development and implementation of new systems to improve data management and project execution
• Hire, mentor and develop team members
• Support regulatory filings by guiding the draft, review, and approval of CMC sections that relate to analytical; engage in associated agency interactions and product-related inspections
• Provide technical support to internal and external cGMP analytical operations
• Develop and manage department budget

Qualifications:

• PhD in Analytical Chemistry, Biochemistry or related disciplines
• 14+ years of biopharmaceutical industry experience with no less than 10 years of that experience focusing on biologics analytical development and execution
• Experience leading a biologics analytical development team
• Experience supporting multiple regulatory filings including IND and BLA
• Supporting product-related inspections for US and foreign regulatory agencies is a plus
• Experience working with external testing organizations including CMOs and contract testing labs
• In-depth understanding of ICH guidelines and GMP requirements for development and manufacturing of biologics
• Solid understanding of current industry trends and regulatory expectations associated with analytical science areas, including but not limited to stability studies, microbial control, comparability evaluation, cell-based assays, and method validation
• Exceptional interaction, leadership and command skills are required
• Leadership qualities of the successful candidate include the following: developing high performing teams, cross functional engagement and influence, collaboration, and strategic vision

Gilead Core Values

• 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 careers@gilead.com for assistance.


For jobs in the United States:
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 careers@gilead.com for assistance.

For more information about equal employment opportunity protections, please view the ‘EEO is the Law' poster.

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PAY TRANSPARENCY NONDISCRIMINATION PROVISION

Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.

Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.

For Current Gilead Employees and Contractors:
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To apply, visit https://gilead.wd1.myworkdayjobs.com/en-US/gileadcareers/job/United-States---California---Oceanside/Executive-Director--Biologics-Analytical-Operations_R0016190-1

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