Key Accountabilities/Core Job Responsibilities
- Prepare media and buffers for production campaigns (including set-up/take-down of equipment and single-use assemblies), including testing and operations.
- Assist with unit operations as requested, including cell culture and purification processes.
- Document manufacturing activities in batch records and record non-conformance issues.
- Follow company policies and Standard Operating Procedures, global regulatory and environmental guidelines.
- Complete assigned training and any required GMP training before executing GMP activities.
- Collaborate with cross-functional teams to optimize manufacturing processes and improve efficiency.
- Partner with Quality and other departments to assess deviations, determine root cause, and execute preventive/corrective actions.
- Clock in/out using designated timekeeping systems; follow timekeeping rules (overtime, meal breaks, and discrepancy reporting).
Qualifications/Skills (Required)
- High school diploma or GED; typically 3 years of relevant industry experience (advanced degree considered toward experience).
- Strong communication skills (verbal/written).
- Ability to build trusted relationships; work confidently in a rapidly changing environment.
- Physical requirements: specialized gowning; lift/manipulate items over 25 lbs; climb ladders; stand for multiple hours.
- Wear PPE (e.g., safety shoes, gloves, eye protection) for extended periods.
Preferred Qualifications
- Manufacturing experience in a regulated industry.
- Product/process support experience in a regulated setting.
- Experience with Good Documentation Practices (GDP) and Good Manufacturing Practices (GMP).
Benefits (as stated)
- Competitive total rewards package including 401k, healthcare coverage, and ESPP.