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Senior Manager, Technical Operations - Fermentation/Chemistry

System One • Lake Forest, IL • 2h ago

Job Title: Senior Manager, Technical Operations - Fermentation/Chemistry

Location: Lake Forest, Illinois

Type: Direct Hire

Compensation: $152,000 - $182,000 annually

Contractor Work Model: Hybrid

Hours: 40.0

Security Clearance: Not specified in the job description or bullhorn fields

Responsibilities

Serve as a subject matter expert in fermentation and chemical manufacturing processes, overseeing products from Master Cell Bank through post-fermentation operations, scale-up, and commercial production.

Design, optimize, and transfer fermentation processes for multiple therapeutic products, guiding them from R&D through scale-up and commercial manufacturing.

Coordinate closely with CMOs on feasibility, scale-up, and transitioning processes from pilot to full commercial production, ensuring process robustness, safety, and compliance.

Utilize analytical tools such as HPLC, GC, filtration systems, and other instrumentation for purification, crystallization, and process validation activities.

Author and review technical documents-including protocols, reports, and regulatory filings-for CMC sections to support the full product lifecycle.

Investigate process deviations, conduct root cause analyses, and support timely process validation activities (IQ/OQ/PQ).

Lead and support technology transfer of processes to pilot plants and manufacturing sites globally, ensuring seamless implementation.

Apply statistical methods such as Design of Experiments and process capability analysis for data analysis and process improvement.

Ensure adherence to cGMP, process controls, and documentation standards.

Collaborate with internal and external stakeholders across Technical, Analytical, Quality, Production, Supply Chain, Project Management, and Regulatory teams.

Requirements

Advanced Degree in Chemical Engineering, Chemistry, Microbiology, or related Life Sciences, possibly with a Ph.D.

8 to 10 years of practical laboratory and manufacturing experience in fermentation and chemical processing, demonstrating expertise in process optimization, troubleshooting, and scale-up operations.

Understanding of cGMP, CMC requirements, and regulatory standards/filings.

Strong knowledge of fermentation processes, upstream and downstream processing, and chemical synthesis steps following fermentation.

Experience with analytical tools such as HPLC, GC, filtration systems, and crystallization equipment.

Ability to investigate process deviations, conduct root cause analyses, and support process validation activities.

Proficiency in statistical methods and data analysis related to process development.

Excellent cross-functional collaboration skills and ability to work under guidance of senior leadership.

System One, and its subsidiaries including Joulé, ALTA IT Services, and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.

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Ref: #568-Clinical

System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

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