Associate I 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 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.
The Associate I of Outsourced Manufacturing will play an important role within the Chemical Development and Manufacturing (CDM) organization to drive projects to progress as planned, at both clinical development and commercial manufacturing stages and ensure delivery of clinical and/or commercial materials (API drug substance and their intermediates) on time, in acceptable quality and in full compliance. They will also be responsible for financial planning/tracking, contract establishment, work order/purchase order generation, timeline/deliverable monitoring and project management. The Senior Associate I will have the opportunity 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.
Specific Responsibilities
- In collaboration with key stakeholders, manages execution and completion of project deliverables within established timelines and in compliance with legal contracts and agreements
- Supports technical transfer activities to new supplier sites
- Negotiates manufacturing schedules and prices with external suppliers
- Reviews contractor documentation including master batch records, specifications, deviations and change controls for GMP compliance and alignment with Gilead standards
- Identifies and purchases custom raw materials, reagents, and other services necessary for the supply of drug substances
- 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 CMOs to support process development or manufacturing activities
- Organizes and participates in teleconferences and face-to-face meetings with CXOs; works closely with Gilead teams to establish agenda and keep track of key decisions and action items
- Proactively communicates issues, project changes to key stakeholders, and facilitates timely discussion and resolution
- Maintains and updates documentation and timelines to accurately reflect the status of the outsourced activities
Skills and Experience
- 2+ 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/MS/MBA degree can be substituted for 2 years of relevant experience.
- Basic understanding of synthetic chemistry and/or pharmaceutical process development
- Ability to effectively manage multiple priorities
- Sound organizational and time management skills
- Strong presentation, oral and written communication skills
- Ability to collaborate with cross functional teams
- Ability to work under uncertainty and to resolve conflict in a constructive manner
- Ability to solve moderately complex problems through ingenuity and collaboration with SMEs and other key stakeholders
- Ability to work in a fast-paced environment
- This position may require domestic and international travel time up to 10%