Manufacturing Associate I - Upstream

Amneal

1d

About The Position

The Manufacturing Upstream Associate I performs hands-on manufacturing operations, executing mammalian cell culture processes and producing recombinant proteins for mammalian-based biosimilars. The role executes cell culture batches at volumes from 50L to 2000L in a current Good Manufacturing Practice (cGMP) environment. Activities include media and buffer preparation, filtration, aseptic procedures in a biosafety cabinet, bioreactor operations, and cell removal filtration.

The position supports upstream manufacturing through equipment setup and operation, production documentation, calculations, process data collection, troubleshooting, and compliance with cGMP, safety, and data-integrity standards. It also manages materials and inventory used in upstream, downstream, and media/buffer preparation processes, and supports audits and regulatory inspections.

Manufacturing Operations runs 12-hour shifts to provide 24/7 coverage on a 2-2-3 schedule, including holidays and weekends. Shift A is 7:00 AM to 7:00 PM EST; initial training may take place on the day shift. Required overtime is paid at time-and-a-half. The hourly rate is $28.00 to $33.00. The role includes a short-term incentive opportunity, such as a bonus or performance-based award, within the first 12 months. Eligible positions receive a flexible benefits program, including health and insurance benefits and a 401(k) matching contribution.

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 effectively with people from other groups in a team-oriented, cross-functional environment.
• Ability to learn proper use of hand and electrical tools.
• 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 the stated 12-hour 2-2-3 schedule, including weekends and holidays, and to work required overtime.

Nice To Haves

• Bachelor’s degree preferred.
• Manufacturing environment experience or 1–2 years of relevant experience preferred.
• General working knowledge of disposable bioreactors, filtration, depth filtration, and single-use consumables such as bags, tube sets, and manifolds.
• Hands-on experience with mammalian cell culture and/or media preparation in a biopharma or biotech manufacturing setting.
• Proficiency in aseptic operations and in-process sampling.
• Experience supporting cGMP operations; commercial exposure is a plus.

Responsibilities

• Execute mammalian cell culture batches from 50L to 2000L in a cGMP environment.
• Prepare media and buffers; perform filtration, aseptic procedures, bioreactor operations, and cell removal filtration.
• Demonstrate understanding of cGMP requirements and follow manufacturing instructions, company policies, safety requirements, and data-integrity standards.
• Document production runs in real time and maintain accurate records and logs.
• Set up, operate, and break down upstream equipment, including bioreactors, depth filtration equipment, and disposables.
• Perform upstream processes at multiple scales in a cGMP environment.
• Calculate processing requirements 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 corrections 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, and manage inventory in cleanroom areas.
• 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.
• Flexible benefits program for eligible positions.
• Health and insurance benefits.
• 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