Associate Director, Outsourced 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
The Associate Director of Outsourced manufacturing will play a critical role within the Chemical Development and Manufacturing (CDM) organization to drive multiple projects at both clinical development and commercial manufacturing stages. The Associate Director will ensure delivery of clinical and/or commercial materials (API drug substance and their intermediates) on time, in good quality and in full compliance. The Associate Director will have the opportunities to work with and learn from colleagues across Gilead (Process Chemistry, Regulatory, Formulations, Analytical, Quality, Supply Chain, etc), as well as multiple CRO and CMO organizations. Strong technical skills (chemistry/engineering, GMP regulation and drug development, etc) and business skills (contract negotiation, project management and financial analysis, etc) will be called upon and excelled at this position.
With the commitment and drive you bring to the CDM workplace, you will be part of a team that is changing the world and helping millions of people live healthier, more fulfilling lives. You will see the tangible results of your contributions, where every individual matters, and everyone has a chance to enhance their skills through on-going 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 CDM at Gilead, you will further our mission to address unmet medical needs and improve life by advancing the care of patients with life-threatening diseases.Specific Responsibilities:
- Manages technical transfer activities to new supplier sites
- Contributes to the development of complex new concepts, techniques and standards in terms of synthetic routes, process scale-ups, and commercial launches
- Contributes to the creation of analytical specifications and procedures with long-term project impacts
- Develops methods, techniques, and evaluation criteria to plan and monitor production of commercial and/or clinical materials
- Ensures all related manufacturing is consistent with appropriate regulations of GMP, ICH, ISO, or environmental control
- Maintains documentation to reflect the effectiveness and efficiency of production and department activities
Knowledge and Experience and Skills
- Closely monitors and manages supply and demand of commercial and/or clinical materials using advanced planning tools
- Collaborates with supply chain partners in monthly planning and execution activities related to Logistics.
- Identifies and purchases custom raw materials, reagents, and other services necessary for the supplies of drug substances
- Negotiates manufacturing schedules and prices with external suppliers
- Manages logistics activities for outsourced materials such as warehousing, transportation, customs clearance, and invoicing
- Frequently interacts with other functional peer group managers within Gilead and CROs/CMOs to support the development or manufacturing activities above
- 10+ years of progressively responsible experience in a related field, including process development, manufacturing, or outsourcing in the pharmaceutical industry and a BA or BS degree in Chemistry or Engineering fields
- A MA/MBA degree can be substituted for 2 years of relevant experience.
- A Ph.D. degree can be substituted for 4 years of relevant experience.
- In-depth understanding and application of pharmaceutical process development and industry practices
- Ability to effectively manage multiple priorities; good organizational and time management skills
- Solid working knowledge of regulatory guidance, including pharmaceutical GMPs and ICH Q7A
- Strong negotiation skills
- Able to develop solutions to a wide range of complex problems
- Exceptional verbal and written communication skills
- Familiarity with the technologies, strengths, and weaknesses of a wide variety of fine chemical and pharmaceutical manufacturers worldwide
- Ability to interact effectively with senior management
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.
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.avature.net/Gilead
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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 firstname.lastname@example.org opens new window" target="_blank" href="https://apptrkr.com/get_redirect.php?id=2552545&targetURL=mailto:email@example.com">firstname.lastname@example.org 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. 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.
For more information about equal employment opportunity protections, please view the EEO is the Law' poster.
NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT
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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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