Manager, Technical Operations (Lyophilization)

Job Title: Manager, Technical Operations (Lyophilization)
Location: Parsippany, New Jersey
Type: Permanent
Compensation: 100K – 135K
Contractor Work Model: Hybrid – onsite and remote
Hours: 40 hours per week

Responsibilities

• Serve as the subject matter expert for lyophilization and sterile drug product manufacturing processes.
• Design, optimize, and scale-up lyophilization cycles, aseptic filling, and formulation processes supporting product development, validation, and commercial manufacturing.
• Lead and support technology transfer activities to pilot plants and manufacturing sites.
• Investigate process deviations, perform root cause analysis, and support process validation (IQ/OQ/PQ).
• Apply statistical tools such as DoE, process capabilities, and ANCOVA for data analysis and process understanding.
• Author and review technical documents including protocols, reports, and regulatory filings for CMC sections.
• Collaborate cross-functionally with internal teams and external contract manufacturing partners, including Technical, Analytical, Quality, Production, and Regulatory personnel.

Requirements

• Degree in Chemical Engineering, Biotechnology, or related Life Science.
• 8 to 12 years of hands-on lab or manufacturing experience in sterile fill/finish, lyophilization, and scale-up.
• Experience in lyophilization cycle development, process modeling, and equipment such as lyophilizers and aseptic fillers.
• Strong understanding of cGMP, CMC requirements, and regulatory standards.
• Ability to investigate process deviations, perform root cause analysis, and support process validation.
• Proficiency in applying statistical methods for data analysis.
• Excellent collaboration skills to work with cross-functional teams and external partners.

System One, and its subsidiaries including Joulé 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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