Manufacturing Associate I - Upstream

Amneal • Piscataway, NJ

2d • $28 - $33

About The Position

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

The position supports upstream production and related material management. It requires accurate, real-time production documentation, adherence to cGMP, safety, and data-integrity standards, and coordination with internal teams and outside vendors to address technical and equipment issues. Manufacturing operates on 12-hour shifts for 24/7 coverage on a 2-2-3 schedule, including weekends and holidays. 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 pay range is $28.00 to $33.00. The position also offers a short-term incentive opportunity, such as a bonus or performance-based award, within the first 12 months. Eligible employees may choose from health and insurance benefits and receive a 401(k) matching contribution, along with employee well-being programs.

Requirements

• High school diploma or equivalent required.
• Familiarity with safety protocols and procedures.
• Ability to understand and adhere to 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 diverse groups in a team-oriented, cross-functional environment.
• Ability to learn to use various 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 in a team and independently with minimum supervision.
• Required to work 12-hour shifts on a 2-2-3 schedule for 24/7 coverage, including holidays and weekends, and required overtime.

Nice To Haves

• Bachelor’s degree.
• Manufacturing environment experience or 1–2 years of relevant experience.
• General working knowledge of disposable bioreactors, filtration, depth filtration, and single-use consumable technologies such as bags, tube sets, and manifolds.
• Hands-on mammalian cell culture and/or media preparation experience 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

• Demonstrate knowledge of cGMP requirements and maintain accurate records and logs through real-time production documentation.
• 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.
• Follow GMP instructions in the manufacturing area and take responsibility for environmental health and safety policies.
• Coordinate investigations and corrections for issues identified during batch execution.
• Ensure operations comply with cGMP, safety, data-integrity, company policies, and standards.
• 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 inside 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.
• Health and insurance benefits for eligible positions.
• 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