Manufacturing Associate - Upstream

Company

Bionova Scientific LLC

As a Manufacturing Associate at Bionova Scientific West Warren, you will actively contribute to manufacturing projects in a GMP multi-product environment. The role involves troubleshooting, system implementation, technology transfers, and hands‑on execution of complex cell culture experiments. You will support GMP activities and ensure compliance throughout the manufacturing process.

• Execute complex unit operations such as media preparation, cell culture thaw, expansion, and end‑of‑production banking; operate single‑use bioreactors and monitor harvest operations.
• Perform internal support tasks including maintenance of analytical equipment, consumable stocking, reagent disposal, and material coordination.
• Maintain personal training records and train other GMP associates upon qualification.
• Support equipment troubleshooting, pilot‑scale material generation, non‑GMP toxicology material generation, and GMP upstream manufacturing tasks.
• Author, review, and approve technical documents: tech transfer protocols, reports, experimental plans, batch records, training materials, manufacturing SOPs, and regulatory filings.
• Document work per cGMP and cGDP guidelines and adhere to site regulations.
• Maintain cleanroom standards, practices, and housekeeping per SOP.
• Identify minor equipment or documentation issues, take corrective action, and report to leads promptly.
• Assess impacts of issues on product safety, efficacy, and project milestones.
• Evaluate new technologies to improve efficiency or expand cell‑culture capabilities.
• Contribute to quality activities: investigations, area walk‑throughs, deviations, CAPA, and change control.
• Perform other duties as assigned to ensure proper compounding practices.

• Lab/office setting with frequent walking, standing, stooping, kneeling, and crouching.
• Occasional lifting or moving of up to 20 pounds independently.

• Associate degree with 1‑2 years of relevant experience or equivalent combination of experience and advanced degree; preference for biopharma manufacturing background.
• Bioreactor operations experience.
• Understanding of mammalian cell culture performance.
• Working knowledge of cGMP compliance related to procedures and manufacturing.
• Experience with process monitoring software (UNICORN, Pi Historian).
• Creative problem‑solving skills to identify efficient solutions.
• Ability to work independently and cross‑functionally.
• Multitasking ability while maintaining detail and working in fast‑paced environment.
• Strong analytical skills and attention to detail.
• Flexible mindset for dynamic environment.
• Availability for flexible work hours, including weekends and holidays as needed.

Base compensation: $25–$30 per hour, dependent on experience and qualifications.

• Health, dental, and vision insurance at subsidized rates.
• Life insurance and disability program fully covered.
• 401(k) retirement plan with up to 8% employer match.
• Paid time off: up to two weeks, 10 holidays, and 5 sick days.

As an equal opportunity employer, Asahi Kasei believes a diverse workforce will provide us with the ability to continuously support the changes in the economy, society, and environment.