Supervisor, Manufacturing Downstream Drug Product, AM Shift

Role Summary

Location: Durham, NC. The role is based in Durham, NC. Relocation assistance is not provided. Step into a leadership role where your expertise in biologics and pharmaceutical manufacturing will drive innovation and quality. As Supervisor, Manufacturing Downstream Drug Product, you’ll guide a shift through safe, compliant, and efficient operations, mentoring the team and delivering excellence in patient care.

Responsibilities

• Oversee shift operations to ensure the safe, compliant, and efficient production of clinical and commercial materials, consistent with site strategic objectives
• Point person on shift to assign/distribute the work to personnel and support any immediate action items
• Leads investigations related to the manufacturing process. Author deviations, non-conformances, and CAPAs as required. Partner with Quality to address these issues effectively and compliantly.
• Ensures documentation (batch records and SOPs) are accurate and updated as required.
• Demonstrates an appropriate level of understanding of the operations performed in the production unit.
• Identify and implement continuous improvement opportunities across production processes
• Summarize shift progress and communicate updates via end-of-shift emails
• Model safety leadership by consistently using proper PPE and promoting safe practices
• Leads and mentors staff, writes performance reviews and annual goals, regular one-on-ones, and handles HR related matters.
• Other related duties as assigned.

Qualifications

• Required: Bachelor's of Science Degree in Biology, Chemistry, Biotechnology or applicable field with 5 years’ experience in cGMP manufacturing operations in biologics, pharmaceutical and/or vaccine manufacturing environments, including experience in cell culture, recovery, purification, bulk formulation and/or fill finish.
• Required: Bachelor's degree in Biology, Chemistry, Biotechnology or applicable field with 3 years of experience in the manufacture of Novartis Gene Therapies product.
• Required: Seven (7) years’ experience in cGMP manufacturing operations in biologics, pharmaceutical and/or vaccine manufacturing, including experience in cell culture, recovery, purification, bulk formulation and/or fill finish, in lieu of a degree.
• Required: Strong knowledge of FDA regulations and GMP systems.
• Required: Excellent communication and technical writing skills.
• Required: Proven project management capabilities including planning, budgeting, and team coordination.
• Preferred: Previous supervisory experience with demonstrated team leadership.
• Preferred: Experience with Drug Product Manufacturing and Purification processes.

Additional Requirements

• Ability to lift 35 lbs. unassisted.