Manufacturing Associate II - Upstream

Amneal • Piscataway, NJ

1d • $33 - $38

About The Position

The Manufacturing Associate II – Upstream is a hands-on role supporting cGMP manufacturing operations for mammalian cell culture processes and production of recombinant proteins for mammalian-based biosimilars. The role executes cell culture batches at scales ranging from 50L to 2000L and performs activities including media and buffer preparation, filtration, aseptic procedures in a biosafety cabinet, bioreactor operations, and cell removal filtration.

The position also supports material and inventory readiness for upstream, downstream, and media/buffer preparation processes. Manufacturing operates on 12-hour shifts with 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.

Requirements

• High school diploma or equivalent.
• 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 collaboratively with a wide range of people and cross-functional groups in a team-oriented 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 required overtime, weekends, and holidays on the stated shift schedule.

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 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

• Demonstrate understanding of cGMP requirements and maintain accurate, real-time production documentation, 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.
• Perform processing calculations, weigh materials, and make chemical and 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 manufacturing areas 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, and data integrity standards, and comply with company policies.
• 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 and receipt checks, and update electronic inventory records.
• Coordinate material readiness with warehouse and planning teams.
• Manage material 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.
• 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: Mid Level
• Education Level: High school or GED