Manager, Outsourced 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 our 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 Gilead Sciences, you will further our mission to address unmet medical needs and improve life by advancing the care of patients with life-threatening diseases.

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. The Manager 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 Manager will have the opportunities to work with and learn from colleagues across Gilead (Process Chemistry, Regulatory, Formulations, Analytical, Quality and Supply Chain), as well as multiple CRO and CMO organizations. Strong technical skills chemistry/engineering, GMP regulation and drug development) and business skills such as contract negotiation, project management and financial analysis will be called upon 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.

Technical 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

·       Executes 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 controls

·       Maintains documentation to reflect the effectiveness and efficiency of production and department activities

Business Responsibilities

·       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, 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

·       Understanding and application 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

·       7+ 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.