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Role Summary
Associate Manufacturing - Nights
Responsibilities
Perform and monitor critical processes, complete routine validation protocols, and regularly draft and revise documents such as Manufacturing Procedures, SOPs, and technical reports.
Perform basic troubleshooting and assist in the review of documentation for assigned functions.
Participate on cross-functional teams and represent the Inoc/Seeds group.
May be responsible for NC/CAPA’s and Change Control records.
Identify, recommend, and implement improvements related to routine functions.
Qualifications
Basic Qualifications:
High school/GED + 2 years of manufacturing or operations work experience OR
Associate’s + 6 months of manufacturing or operations work experience OR
Bachelor’s
Preferred Qualifications:
Knowledge of small scale bioreactors, wave bioreactors, and aseptic processing.
CFR and Regulatory knowledge
Mechanical ability/expertise
Knowledge of WIP lab equipment and computers, with LIMS access
Basic statistical mathematical skills
Ability to interpret and apply GMP knowledge
Understanding of analytical methods for manufacturing area
Ability to demonstrate technical writing capability with Trackwise access
Able to demonstrate project management skills and presentation skills
Independently collaborate with outside resources
Ability to understand, apply and evaluate basic chemistry, biology and physical principles
Basic troubleshooting skills on bioreactors
Experience with Delta V, RD’s
Experience with lab equipment/testing
Skills
Technical writing
GMP knowledge
Project management
Analytical and problem-solving skills
Cross-functional collaboration
Education
Additional Requirements
12-hour rotating shift (7PM-7AM) with 15% shift differential and premium pay for Sundays; onboarding schedule may be 8am-5pm for 2-6 weeks.