Manufacturing Associate - Upstream - Temporary & Full Time

Bionova Scientific LLC; United States; On-site; USD 34,440 - 41,328; Full time

Job summary

Bionova Scientific LLC is seeking a Manufacturing Associate for our West Warren site to support GMP manufacturing and cell culture projects. You will work across troubleshooting, tech transfers, and process implementations in a multi‑product facility, contributing to complex experiments in a collaborative team.

The role requires an Associate degree with 1–2 years of experience, bioreactor experience, and strong knowledge of cGMP.

Qualifications

• Associate degree with 1–2 years of relevant experience or equivalent
• Bioreactor operations experience and mammalian cell culture knowledge
• Working knowledge of cGMP compliance
• Experience with process monitoring software and equipment software (UNICORN, Pi Historian)
• Creative thinker with ability to address issues and gaps
• Ability to work independently and in cross‑functional teams

Responsibilities

• Execute complex unit operations under supervision, including media prep, cell culture thaw/expansion, harvest, and bioreactor operation
• Maintain analytical equipment and stocking of consumables; handle material coordination
• Maintain training and provide training to other GMP associates upon qualification
• Support equipment troubleshooting, pilot-scale material generation, and GMP upstream activities
• Author and review technical documents: tech-transfer plans, batch records, SOPs, and regulatory filings
• Document work per cGMP/cGDP; ensure cleanroom practices and housekeeping
• Identify equipment issues or documentation discrepancies; notify leads immediately
• Assess impact of issues on product safety, efficacy, and milestones
• Evaluate new technologies to improve operations and cell culture capacity
• Contribute to quality activities: investigations, deviations, CAPA, change control
• Other duties to ensure proper compounding practices

Skills

Biopharma manufacturing

Cell culture

cGMP compliance

Analytical skills

Cross-functional teamwork

Independent work

Education

Associate degree or higher

Tools

UNICORN

Pi Historian

Job description

Company Summary

Bionova is a rapidly growing, biologics CDMO focused on developing and manufacturing recombinant protein products using mammalian cell culture processes. The company, now a subsidiary of Asahi Kasei Medical since May 2022, embraces an agile and energized culture that brings together top scientific talent, the best available tools, and innovative solutions to solve difficult client problems.

Position Summary

The Manufacturing Associate will actively contribute to manufacturing projects at the Bionova Scientific West Warren site. As part of the Cell Culture/Manufacturing group, you will work across a wide range of projects, including troubleshooting, investigations, system and workflow implementation, and technology transfers of processes into a GMP multi‑product manufacturing facility. This hands‑on role supports GMP and manufacturing activities and involves execution of complex experiments within a collaborative team setting.

Essential Duties and Responsibilities

• Execute, with oversight of qualified staff, complex unit operations such as media preparation, cell culture thaw, expansion, bank, and end‑of‑production harvesting; operate single‑use bioreactors and manage process monitoring and harvest operations.
• Perform internal support activities, including maintenance of analytical equipment, stocking consumables, discarding expired reagents, material coordination, weighing, and dispensing.
• Maintain own training in compliance and provide training to other GMP associates upon completion of trainer qualification.
• Support equipment troubleshooting, pilot‑scale material generation, non‑GMP tox material generation, and GMP upstream manufacturing activities.
• Author, review, and approve technical documents such as tech‑transfer protocols, experimental plans, production batch records, training materials, manufacturing SOPs, and regulatory filing documents per project needs.
• Document work in accordance with cGMP and cGDP guidelines, adhering to established regulations.
• Maintain cleanroom standards, practices, and housekeeping as per SOPs.
• Recognize minor equipment issues or documentation discrepancies, take corrective action, and notify leads/ managers immediately.
• Assess impact of issues and non‑conformities on product safety, efficacy, and project milestones.
• Evaluate new technologies and innovations to improve operational efficiency or expand cell‑culture capabilities.
• Contribute to quality activities including investigations and area walk‑throughs, and support authoring deviations, CAPA, and change control.
• Other duties as assigned to ensure appropriate compounding practices.

Working Conditions

Required to work in a lab/office setting. The role involves walking, standing, stooping, kneeling, and crouching. The employee must occasionally lift or move up to 20 pounds independently.

Qualifications

• Minimum of an Associate degree with 1‑2 years of relevant experience, or an equivalent combination of experience and an advanced degree in biopharma manufacturing.
• Must have bioreactor operations experience and a strong understanding of mammalian cell culture performance.
• Working knowledge of cGMP compliance as it pertains to procedures, processes, and manufacturing.
• Experience with process monitoring software and equipment software (UNICORN, Pi Historian).
• Creative thinker capable of identifying better and more efficient methods to address issues and gaps.
• Demonstrated ability to work independently and on cross‑functional teams.
• Ability to handle multiple tasks simultaneously while maintaining attention to detail in a fast‑paced environment.
• Strong analytical skills and meticulous attention to detail.
• Flexible mindset for a dynamic environment.
• Flexibility with work hours to meet business needs, including weekends and holidays as required.

Compensation

The base compensation range for this role is between $25 and $30 an hour. Actual compensation may vary depending on experience and qualifications.

Equal Opportunity Employer

Asahi Kasei is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, disability, veteran status, or any other protected classification.