Director, Late-Stage Upstream Process Development
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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to apply for this job.Job Description
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. Our scientific focus has resulted in marketed products that are benefiting hundreds of thousands of people, a pipeline of late-stage drug candidates, and unmatched patient access programs to ensure medications are available to those who could otherwise not afford them. By joining Gilead, you will further our mission to address unmet medical needs and improve life by advancing the care of patients with life-threatening diseases.Role and Responsibilities:
The Director, Late-Stage Upstream Process Development will have accountability for strategies and work including late-stage upstream process development, scale-up, upstream process robustness and characterization, and upstream process validation and control. The successful candidate will author relevant sections of BLAs, late-stage regulatory filings, and supporting reports. In this role, you will also manage a team of scientists and research associates who conduct the above activities. You will have the opportunity to lead cross-functional teams and represent upstream development on cross-functional teams.Essential Duties and Job Functions:
Knowledge, Experience and Skills:
- Leads a team of scientists that is responsible for upstream process development, scale-up, upstream process robustness and characterization, and upstream process validation and control.
- Supports upstream process-related technology development.
- Drives process improvements for increased speed and efficiency to generate highly productive, upstream manufacturing processes that deliver high quality product.
- Develops and motivates team and develops careers of direct and indirect reports.
- Defines strategies for late-stage development.
- Drives business process improvements related to late-stage process development.
- Manages upstream functional resources that support multiple cross-functional teams.
- Focuses on strategic planning and execution while managing within the budget.
- Authors relevant sections of BLAs, late-stage regulatory filings, and supporting reports and information requests.
- Ensures compliance to safety, business policies, laws, and regulations applicable to the operations.
- Reviews GMP and non-GMP technical documentation (batch records, SOPs, and process validation/characterization protocols and reports).
- Supports investigations and identifies root causes for critical deviations.
- Some travel may be required to support internal and external technology transfers and provide manufacturing oversight of CMOs.
- 8+ years of experience in the pharmaceutical industry and PhD in a relevant scientific discipline such as Chemical Engineering, Bioengineering, or Biochemical Engineering or BS or MS with extensive industry experience.
- Demonstrated excellence in cell culture and upstream process development, process technology transfer, scale-up, and statistical DOE (design of experiments) is required; strong understanding of phase-appropriate development preferred.
- Ability to think critically, and demonstrated troubleshooting and problem-solving skills.
- Excellent interpersonal, communication, and presentation skills are required.
- Experience with antibody and antibody-like proteins is required; experience with other modalities preferred.
- Experience with technology development/implementation projects both functionally and cross-functionally is preferred.
- Experience with leading the strategy and work of late-stage process development, upstream process characterization, and upstream process validation and control is required.
- Experience supporting commercial manufacturing is preferred.
- Experience with the preparation of regulatory filings for US or external markets including BLAs is required.
- Flexibility and a willingness to expand skill set and responsibilities is a must.
- Supervisory experience is required.
If this is not the right move for you now but you remain interested in a career at Gilead Sciences, please connect with us via our talent community: https://gilead.avature.net/Gilead.About Gilead:
Gilead Sciences, Inc. is a research-based biopharmaceutical 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.
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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 email@example.com
for assistance.Following extensive monitoring, research, consideration of business implications and advice from internal and external experts, Gilead has made the decision to require all U.S., Canada, Australia, Singapore, and Hong Kong employees and contractors to receive the COVID-19 vaccines as a condition of employment. “Full vaccination” is defined as two weeks after both doses of a two-dose vaccine or two weeks since a single-dose vaccine has been administered. Anyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, can request a reasonable accommodation.
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