Role Summary
Engineer III responsible for bioreactor operations from 250 mL to 10 L, supporting tech transfer of cell culture processes to pilot and manufacturing facilities, and contributing to experimental design, data interpretation, and technical documentation. Expected to collaborate across process development, optimization, characterization, and troubleshooting to meet project goals. Location: Lexington, MA. Up to 20% remote work allowed.
Responsibilities
- Independently carry out bioreactor operations across scales (250 mL to 10 L).
- Prepare experimental protocols and support tech transfer of developed cell culture processes to pilot and manufacturing facilities.
- Design experiments, interpret data, identify complex technical issues, and implement solutions under supervision.
- Contribute to technical reports by writing and consolidating technical documents.
- Interact with process development, optimization, characterization, troubleshooting, and large-scale studies to support project goals.
- Support technology transfer by writing/consolidating technical documents, reviewing batch records, and coordinating across departments and cross-functional peers.
- Evaluate new technology/equipment applicable across programs.
- Document data according to company guidelines; draft technical reports, memos, procedures, protocols, and presentations; participate in cross-functional project teams and present at meetings.
- Execute bioreactor operations, clarifications, and purification using high-throughput systems (e.g., ambr250 and Tecan).
Qualifications
- Masterโs degree in Chemistry, Biology, Pharmacy, Engineering, or related Pharmaceutical Science.
- Experience executing bioreactor operations, primary clarification, and purification using high-throughput systems (e.g., ambr250, Tecan).
- Ability to interpret experimental data, identify technical issues, and implement solutions; contribute to evaluation/integration of new technologies across programs.
- Collaborate with cross-functional teams to support tech transfer to pilot, manufacturing, and external CDMOs.
- Author/revise technical documents including SOPs and process development reports; provide cross-training on analytical instruments and techniques.
- Conduct product quality testing using tools such as Solo-VPE, Lunatic, HPLC, UPLC, and UV spectrophotometer.
Skills
- Bioreactor operations and process development
- Tech transfer and cross-functional collaboration
- Experimental design and data interpretation
- Documentation and technical reporting
- Analytical instrumentation (HPLC/UPLC/UV, Solo-VPE, Lunatic)
Education
- Masterโs degree in Chemistry, Biology, Pharmacy, Engineering, or related Pharmaceutical Science
Additional Requirements
- Up to 20% remote work allowed