The Manager 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 to progress as planned and ensure delivery of clinical and/or commercial materials (API drug substance and their intermediates) on time, in good quality and in full compliance. The manager 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 and Skills:
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, technique 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 documentations to reflect the effectiveness and efficiency of production and department activities
Closely monitors and manages supply and demand of commercial and/or clinical materials using advanced planning tools
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, custom clearance and invoicing
Frequently interacts with other functional peer group managers within Gilead and CROs/CMOs to support the development or manufacturing activities above
In-depth understanding of pharmaceutical process development
Ability to effectively manage multiple priorities
Working knowledge of GMPs and associated regulations
Sound organizational and time management skills
Strong negotiation and problem solving skills
Exceptional verbal and written communication skills
Ability to interact effectively with senior management
Knowledge and Experience
6+ 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.
Employer will assist with relocation costs.
Internal Number: R0011916
About Gilead Sciences
Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. We strive to transform and simplify care for people with life-threatening illnesses around the world. Gilead's portfolio of products and pipeline of investigational drugs includes treatments for HIV/AIDS, liver diseases, cancer, inflammatory and respiratory diseases, and cardiovascular conditions.Our portfolio of marketed products includes a number of category firsts, including complete treatment regimens for HIV infection available in a once-daily single pill and the first oral antiretroviral pill available to reduce the risk of acquiring HIV infection in certain high-risk adults.