Position Summary
- The Associate, Manufacturing supports biological manufacturing and performs manufacturing functions in adherence to cGMP and GDP to ensure quality operations.
Essential Functions
- Perform manufacturing activities per cGMP guidelines (batch record execution/review, product/equipment changeover, troubleshooting, issue resolution).
- Execute process operations according to the production timeline.
- Ensure safety and cGMP compliance at all times; communicate transparently with management.
- Use cell culture expansions and aseptic techniques.
- Develop and author cGMP documentation for cell culture manufacturing processes.
- Maintain aseptic gowning qualification and participate in semi-annual media fills.
- Work cross-functionally to streamline cGMP manufacturing operations.
- Cross-train and assist with multiple cell line operations as required.
- Contribute to process improvement initiatives for cell culture equipment/operations.
- Assist with ordering materials and ensure equipment/material availability for production runs.
- Adhere to SOPs and cGMP; maintain training profile requirements.
- Perform ad-hoc/cross-functional duties and projects as assigned.
Education & Experience
- Bachelorβs degree in chemical engineering, genetics, molecular biology, biotechnology, microbiology, biochemistry, or related field (required).
- Relevant industry or research experience (preferred).
- Bio-manufacturing experience (preferred).
Knowledge/Skills
- Attention to detail; cleanliness; flexibility.
- Apply safety and quality requirements; strong cGMP adherence.
- Teamwork and effective communication.
- Hands-on approach; Microsoft Word/Excel/PowerPoint.
- Ability to read/apply SOPs and manufacturing batch records.
Benefits
- Eligible for discretionary bonus and equity award; medical, dental, and vision plan options.
Application Instructions
- Application window anticipated to close 60 days from posting or sooner if filled/closed.