Downstream Manufacturing Scientist I (Associate I)

Amneal

7d • Onsite

About The Position

The Downstream Manufacturing Associate is a hands-on manufacturing role executing downstream processing to purify recombinant proteins for mammalian-based biosimilars. The role purifies harvest material at scales from 50 L to 2,000 L in strict cGMP environments and maintains required quality documentation. Work includes preparing media and buffers, filtration, aseptic procedures in a biosafety cabinet, bioreactor operations, and cell-removal filtration.

The position operates downstream equipment and processes at multiple scales, including chromatography columns and tangential flow filtration systems. It also involves process calculations, material handling, troubleshooting, data analysis, equipment maintenance coordination, investigations, and updates to manufacturing documents. The role supports inventory and material readiness for upstream, downstream, and media/buffer preparation processes, and provides support during audits and regulatory inspections.

This is an hourly, onsite position at the Piscataway, New Jersey facility. Manufacturing Operations provides 24/7 coverage on 12-hour shifts under a 2-2-3 schedule, including weekends and holidays. Required overtime is paid at time-and-a-half, and applicable evening shifts receive shift differentials. Initial training may take place on the day shift. The hourly rate is $28.00–$33.00, and the position includes an opportunity for a short-term incentive, such as a bonus or performance-based award, within the first 12 months. Eligible employees have access to health and insurance benefits, a significant 401(k) matching contribution, and employee well-being programs.

Requirements

• High school diploma or equivalent required.
• Familiarity with safety protocols and procedures.
• Ability to understand and follow written and verbal instructions.
• Excellent written and verbal communication skills, including the ability to communicate technical details at all levels, including senior leadership.
• Ability to work with a wide range of people in a team-oriented, cross-functional environment.
• Ability to learn to use hand and electrical tools properly.
• Ability to work in a fast-paced environment and handle changing manufacturing demands.
• Proficiency in MS Word, Excel, and PowerPoint.
• Ability to troubleshoot technical issues and propose short- and long-term solutions.
• Strong time-management skills and ability to work under demanding timelines.
• Ability to work both in a team and independently with minimal supervision.
• Ability to work 12-hour shifts as scheduled, including weekends and holidays, and to work required overtime.
• Ability to work flexible hours as needed, under pressure, and to meet deadlines.
• Ability to move around the facility, stand for long periods, and perform occasional bending, squatting, kneeling, stooping, pushing, pulling, reaching, and walking.
• Ability to lift at least 25 lbs.; frequent lifting or moving of approximately 25–50 lbs.; and frequent assisted transport of approximately 100–250 lb. buffer drums on casters.
• Ability to perform frequent repetitive motions.

Nice To Haves

• Bachelor’s degree preferred.
• Manufacturing-environment experience or 1–2 years of relevant experience preferred.
• General working knowledge of AKTA purification skids or similar equipment, TFF, columns, and single-use consumable technologies such as bags, tube sets, columns, and process manifolds.
• Previous hands-on experience with mammalian cell lines in a GMP and aseptic commercial manufacturing setting in biopharma or biotech.
• Proficiency in aseptic operations and in-process sampling.

Responsibilities

• Execute downstream processing to purify recombinant proteins from harvest material at scales of 50 L to 2,000 L in a cGMP environment.
• Demonstrate knowledge of cGMP requirements and follow GMP instructions, safety requirements, and data-integrity standards.
• Maintain accurate, real-time production documentation, records, and logs.
• Set up, operate, and break down downstream equipment, including chromatography columns, controllers, and TFF systems.
• Perform downstream processes at multiple scales, column packing, process troubleshooting, and data analysis.
• Prepare media and buffers; perform filtration, aseptic procedures, biosafety cabinet and bioreactor operations, and cell-removal filtration.
• Perform processing calculations and weigh materials and chemical or reagent additions.
• Use programs to collect and evaluate operating data and make online adjustments to products, instruments, or equipment.
• Work with other teams and outside vendors to resolve technical issues and support production equipment maintenance.
• Coordinate investigations and corrective actions for issues identified during batch execution.
• Revise solution-preparation batch records, SOPs, protocols, and logbooks.
• Support quality audits and regulatory inspections.
• Order, maintain, track, and stage raw materials and consumables for upstream, downstream, and media/buffer preparation processes.
• Perform label verification, receipt checks, and electronic inventory updates; coordinate material readiness with warehouse and planning teams.
• Manage material inventory in cleanroom areas.
• Comply with company policies and standards and take ownership of environmental health and safety policies.
• Perform other functions as required or assigned.

Benefits

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

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: High school or GED