Manufacturing Specialist

Role Summary

Manufacturing Specialist at Gilead. Responsible for leading process development, technology transfer, and manufacturing operations within a phase-appropriate cGMP environment to support the discovery, development, and delivery of therapies for life-threatening illnesses.

Responsibilities

• Demonstrates hands-on technical leadership of process development, technology transfer, and process operations within a phase-appropriate cGMP environment.
• Execute 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.

Qualifications

• Basic: M.S. with 2+ years or BS with 4+ years‚Äô experience in a relevant scientific discipline (chemical engineering, biochemistry, bioengineering).
• Preferred: Strong understanding of biologics/sterile injectable product manufacturing processes (bulk freeze/thaw, mixing/pooling, filtration, filling, lyophilization).
• Preferred: Experience supporting drug product manufacturing operations, technology transfer, and/or development; prior experience with commercial manufacturing and/or process validation is highly desirable.
• Preferred: 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.
• Preferred: Broad understanding of downstream development and scale up including process transfers for new product introduction into production lines.
• Preferred: Experience in pivotal stage purification process development, characterization, and implementation in GMP facilities.
• Preferred: Working knowledge of cGMPs and regulatory requirements of biopharmaceutical manufacturing.
• Preferred: Experience in cleaning process design, verification, and cross contamination strategies.
• Preferred: Motivated self-starter with excellent interpersonal and organizational skills; strong verbal communication, presentation, and scientific writing skills.

Education

• MS with 2+ years or BS with 4+ years in a relevant scientific discipline.