Manufacturing Specialist

Manufacturing Specialist

United States - California - La Verne Manufacturing Operations & Supply Chain Regular

Gilead's mission is to discover, develop, and deliver therapies that will improve the lives of patients with life-threatening illnesses worldwide. As a Manufacturing Specialist
, you are responsible for:

• Demonstrates hands‑on technical leadership of process development, technology transfer, and process operations within a phase appropriate cGMP environment.
• Responsible for executing technology/process transfer from Lab to manufacturing production floor and provide technical input and support during manufacturing of drug products.
• Lead the design and development of downstream processes, including design of experiments, process optimization, data interpretation and analysis.
• Author or review technical documentation (development reports, process description, process flow protocols, batch records, etc).
• Mentor junior team members on process operations and development strategies, experimental design and execution as well as process transfer.
• Participate in cross functional initiatives.
• Adhere to department budget and all training, compliance, and safety requirements.

M.S. with 2+ years or BS with 4+ years’ experience in a relevant scientific discipline (chemical engineering, biochemistry, bioengineering).

• Strong understanding of biologics/sterile injectable product manufacturing processes e.g., bulk freeze/thaw, mixing/pooling, filtration, filling and/or lyophilization.
• Experience supporting drug product manufacturing operations, technology transfer, and/or development. Prior experience with commercial manufacturing and/or process validation is highly desirable.
• Hands‑on experience with process operations including centrifugation, normal flow filtration, high throughput purification screening and development, chromatography operations, tangential flow filtration, formulation development and technical transfer.
• Broad understanding of downstream development and scale up including process transfers for new product introduction into theli>
• Experience in pivotal stage purification process development, characterization, and implementation in GMP facilities.
• Working knowledge of cGMPs and regulatory requirements of biopharmaceutical manufacturing.
• Experience in cleaning process design, verification, and cross contamination strategies.
• Motivated self‑starter with excellent interpersonal and organizational skills. Excellent verbal communication, oral presentation, and scientific writing skills.