The successful candidate will have practical laboratory fermentation experience in executing, supporting, or developing upstream processes related to biotechnology, biopharmaceuticals, or vaccine industries. The candidate will be eager to utilize and learn new laboratory skills as this person will be responsible for collaboration on experimental design and execution of experiments at pilot scale for scale down modelling efforts and manufacturing program development. This position will require >50% time in the lab and this person will be able to independently detail experimental procedures/results in written and presentation formats. The successful candidate will write detailed technical reports, present experimental results internally, and potentially interface with external CMO partners.
Essential Functions:
- Perform pilot scale fermentor operations within USP operations, focusing on the scale down model of the current manufacturing process.
- Includes setting up, operating, and monitoring the fermentor operations along with troubleshooting, and support equipment such as sensors and gas and metabolite analyzers.
- Perform recovery operations including depth filtration, tangential flow filtration and centrifugation.
- Microbiological analysis of fermentation results for yield and impurities.
- Assists in design and execution of upstream process characterization studies.
- Work with the team to develop plans for upstream process development and material generation needs for scale down model development.
- Keep accurate and current records of development experiments and/or project related activities within Benchling.
- Review executed batch records from Manufacturing and support deviations/CAPAs/CRs.
- Present/communicate data and contribute to technical discussions within the team.
- Write and develop protocols for execution and reports in support of process development.
Requirements:
- BS in Chemical Engineering, Biochemistry, or a related discipline, with 5+ years of industry experience; MS with 3+ years of industry experience.
- Practical experience in supporting/execution of bioprocess operations such as fermentation or cell culture.
- Demonstrated understanding/proficiency with engineering principles involved in scaling processes (lab, pilot, manufacturing)
- Familiarity with DoE (Design of Experiments) principles and ability to perform. statistical data analysis with collected data.
- Process characterization experience is a plus.
- Working knowledge of the requirements of GxP standards.
- Demonstrated success working in a cross-functional team environment on multiple. projects; ability to work effectively as a member of a team to deliver results.
- Strong interpersonal skills, with excellent written and verbal communication skills.
- All employees require vaccination against COVID-19.
Compensation: The compensation package will be competitive and includes comprehensive benefits and an equity component.
Salary range: $107K- 120K annually