Associate Director, Pilot Plant Operations

$177,905 - $230,230/Yr

Gilead Sciences - Foster City, CA

Full-time - Senior

Foster City, CA

Chemical Manufacturing

About the position

The Associate Director of Pilot Plant Operations at Gilead Sciences is a leadership role focused on overseeing the manufacturing of Active Pharmaceutical Ingredients (APIs) in a Good Manufacturing Practices (GMP) environment. This position is critical in ensuring safe, compliant, and efficient production processes while collaborating with cross-functional teams to develop innovative therapies. The role involves managing production schedules, addressing quality and safety concerns, and supervising manufacturing staff to achieve operational excellence.

Responsibilities

• Responsible for safe, flexible, and compliant manufacture of drug substances in GMP facilities.
• Address environmental, quality, and safety concerns.
• Coordinates production schedules based on project priorities.
• Ensures appropriate change management and qualification of new and upgraded equipment.
• Ensures manufacturing areas, equipment, and procedures meet all current regulatory requirements.
• Contributes to authoring of and reviewing pre- and post-execution batch production records.
• Identify and implement cost reductions in materials, equipment, or overhead.
• Supervision of manufacturing staff.
• Advise members of project teams in the design and execution of API manufacturing, considering economic, sustainability, regulatory and safety factors.
• Management of calibration and maintenance activities using a computerized maintenance management system (CMMS).
• Author, review, and approve quality documents (Deviations, Change Controls, Impact Assessments, etc.) in a quality document management system.

Requirements

• PhD in Organic Chemistry (or related discipline) with 2+ years of relevant experience, OR MS degree with 8+ years of relevant experience, OR BS degree with 10+ years of experience.
• Understanding and application of manufacturing principles governed by current Good Manufacturing Practices (cGMP).
• Experience in planning and executing small molecule cGMP manufacturing.
• Demonstrated ability to work in multi-disciplinary teams, learn new skills, and proactively solve problems.
• Familiarity with continuous quality improvement methodologies such as Lean Six Sigma, Kaizen, and 5S.

Benefits

• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Vision insurance