Manufacturing Supervisor (Downstream) - 12 Hour Night Shift

Amneal • Piscataway, NJ

2d • $90,000 - $110,000

About The Position

The Downstream Manufacturing Supervisor is a hands-on role responsible for executing purification of mammalian cell-based cultures and producing recombinant proteins for mammalian-based biosimilars. The position oversees purification of 50L to 1000L engineering, clinical, and commercial batches in a cGMP environment. It requires technical expertise with AKTA purification skids or similar equipment, TFF, and preparation of batch records, protocols, investigations, and other technical documents.

The supervisor works with a team to execute batches and must also be able to work independently with minimal supervision. The role requires extensive expertise in mammalian cell-based purification processes, cGMP manufacturing, and compliance for BLA requirements. The position works a 12-hour night shift; flexible hours and some travel may be involved.

Requirements

• At least 7 years of related experience in the biopharmaceutical industry.
• Previous experience in a GMP and aseptic manufacturing environment.
• Experience with AKTA process skids or similar equipment and familiarity with single-use manufacturing consumables such as bags, tube sets, columns, and process manifolds.
• Knowledge to execute engineering and clinical batches and familiarity with GMP documentation.
• Bachelor's degree in chemical, biological, or biochemical sciences.
• Ability to work a 12-hour night shift.
• Ability to work with team members and independently, with good interpersonal skills.
• Good verbal and written communication and documentation skills, computer and organizational skills, and attention to detail.
• Basic computer skills, including knowledge of Word, Excel, and spreadsheets.
• Knowledge of GMP batch manufacturing and packaging documentation, auditing, and review.
• Knowledge of cleaning verification and validation.
• Ability to work flexible hours as needed and under pressure to meet deadlines.
• Some travel may be involved.

Nice To Haves

• Master's degree.

Responsibilities

• Perform and supervise downstream processes at multiple scales in a cGMP environment, including column packing, process troubleshooting, and data analysis.
• Provide technical direction in the execution and development of the purification process.
• Use programs to collect and evaluate operating data and make online adjustments to products, instruments, or equipment.
• Prepare and review quality management documents, including deviations, change controls, and investigation reports.
• Ensure engineering and clinical batches are executed in a timely manner.
• Establish operating equipment specifications and improve manufacturing techniques.
• Work with other teams and outside vendors to resolve technical issues and maintain production equipment.
• Follow GMP instructions in the manufacturing area and lead adherence to environmental health and safety policies.
• Coordinate investigations and corrections for issues identified during batch execution.
• Perform other functions as required or assigned.
• Comply with company policies and standards.

Benefits

• Short-term incentive opportunity, such as a bonus or performance-based award within the first 12 months.
• Comprehensive, flexible, and competitive benefits program for eligible positions, including health and insurance benefits.
• Significant 401(k) matching contribution.
• Employee well-being programs.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior