Downstream Manufacturing Scientist I (Associate I)

Amneal India • Piscataway, NJ

7d • $28 - $33 • Onsite

About The Position

The Downstream Manufacturing Scientist I is a hands-on manufacturing role responsible for downstream processing and purification of recombinant proteins for mammalian-based biosimilars. The role processes harvest material at scales from 50 L to 2,000 L in strict cGMP environments and requires accurate, real-time quality documentation. Work also includes preparing media and buffers, filtration, aseptic procedures, biosafety cabinet and bioreactor operations, and cell removal filtration.

The position supports downstream production operations, including equipment setup and operation, column packing, process troubleshooting, data analysis, material calculations and handling, production-data evaluation, and coordination with other teams and vendors. It also includes inventory management, document revision, investigation support, and assistance during audits and regulatory inspections.

Manufacturing operates on 12-hour shifts providing 24/7 coverage on a 2-2-3 schedule, including weekends and holidays. Shift A is 7:00 AM to 7:00 PM EST, and Shift B is 7:00 PM to 7:00 AM EST; initial training may take place on day shift. Overtime is required and paid at time-and-a-half, with shift differentials for applicable evenings. The position is an hourly, overtime-eligible FTE role and is conducted onsite at the Piscataway, New Jersey facility.

The work environment includes cleanrooms and/or laboratories that are adequately lit, ventilated, and temperature controlled. Employees wear appropriate PPE, and may encounter chemical odors and dust. Work involves moving around the facility, standing for extended periods, repetitive motion, occasional desk and computer work, and frequent lifting and moving of materials, including buffer drums transported on casters with assistance.

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 people across 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 adapt to 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 as part of a team and independently with minimal supervision.
• Ability to work flexible hours as needed, under pressure, and to 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. and frequently lift or move approximately 25–50 lbs.
• Ability to frequently transport approximately 100–250 lb. buffer drums on casters with assistance.
• 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, tangential flow filtration (TFF), columns, and single-use consumable technologies such as bags, tube sets, columns, and process manifolds.
• Hands-on experience working 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 and purification of recombinant proteins for mammalian-based biosimilars at harvest scales of 50 L to 2,000 L in cGMP environments.
• Prepare media and buffers and perform filtration, aseptic procedures, biosafety cabinet and bioreactor operations, and cell removal filtration.
• Follow cGMP requirements and 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, pack columns, troubleshoot processes, and analyze data.
• Calculate processing requirements and weigh materials, chemicals, and reagents for 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 maintain production equipment.
• Follow manufacturing GMP instructions 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.
• Provide support during 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 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.
• Comprehensive, 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