Director, Pharmaceutical Manufacturing
Director, Pharmaceutical Manufacturing
United States - California - Foster City
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. Gileads 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 companys five core values. Thats 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
Director, Pharmaceutical Manufacturing
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. Join a dynamic technical team overseeing commercial manufacturing processes to ensure an uninterrupted supply chain. The successful candidates will have extensive experience in scale up, technology transfer and process validation of parenteral dosage form. The candidates will have demonstrated leadership on technical projects with the ability to work on a cross- functional team.
Essential Duties and Job Functions
- Responsible for planning and implementing activities on projects related to scale-up, validation, and technology transfer of sterile manufacturing processes at CMO sites.
- Liaison with Formulation and Process Development technical lead to technology transfer new sterile products to CMO's sites for commercialization.
- Performs troubleshooting, root cause analysis, and impact assessments for complex investigations with guidance
- Understand and apply the concepts of aseptic technique, microbial control and particulate control to the manufacturing area.
- Support/lead continued process verification (CPV) related activities for sterile manufacturing processes
- Uses statistical techniques and software (e.g. JMP, Minitab, etc) to analyze process data to determine statistical significance, assess potential correlations, and evaluate process capability
- Interfaces with contract manufacturers to address standard documentation and compliance issues.
- Assess deviations from established production procedures in support of batch release.
- Develops strategies to implement changes to processes.
- Monitor and provide Person-in-Plant (PIP) support for sterile manufacturing at CMO's.
- Contributes to organization processes across functions and interacts effectively with the other team members.
- With guidance, prioritizes own work to ensure conformance to departmental goals.
- Writes internal procedures required to ensure GMP compliance
- Supports and revises specifications and resolves technical issues with material/component suppliers.
- Works with CMC Regulatory in developing a global filing strategy for commercial products and author CMC sections and response to questions from regulatory agencies.
- Ensures regulatory commitments are met.
- Exercises judgment within well-defined and established procedures and practices to determine appropriate action with minimal supervision.
Knowledge & Skills
- Strong knowledge of the FDA and cGMP standards as well as regulatory guidance documents.
- Audit and Investigation Skills, Report Writing Skills.
- Strong verbal, technical writing and interpersonal skills are required.
- Well with statistical techniques and data analysis.
- Proficiency in Microsoft Office applications.
Education & Experience
- A Bachelor's Degree and a minimum of ten (10) years of relevant experience and a BS or BA OR a Master's Degree and a minimum of eight (8) years of relevant experience.
- Experience on sterile fill/finish process scale-up and technology transfer.
- Familiarity with use of statistics, root cause analysis, and risk assessment tools (e.g. statistical significance, process trends, process capability, Fish bone diagrams, FMEA, etc.).
- Experience on cGMPs, regulatory filings, and compliance for sterile injectable products manufactured by aseptic processing.
- Ability to travel up to 30% if needed.
- A Master's Degree in Chemical/Biomedical Engineering, Pharmaceutical Sciences, Chemistry or Biotechnology.
If this is not the right move for you now but remain interested in a career at Gilead Sciences please connect with us via our talent community: https://gilead.yello.co/external/form/24a8oU4jF5UL3CKq7lO_Cg
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.
For more information about equal employment opportunity protections, please view the EEO is the Law' poster.
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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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