R&D Associate II-PD Upstream
GENERAL SUMMARY OF POSITION:
The Research Associate II, Process Development – Upstream, is responsible for overseeing upstream cell culture process development activities. Including supporting the development of media and feed supplements, optimization and scale-up of cell culture processes for the production of monoclonal antibodies, recombinant proteins and viral vectors, as well as technical transfer to Manufacturing. The Associate II will manage the preparation, formulation, and filtration cell culture basal media and reagents. Additionally, the Associate II will provide lab coverage during evenings, weekends, and holidays on a rotating basis, as required to support upstream development activities. The incumbent will perform established assays and contribute to the development of new assays.Responsibilities
- Maintain or supervise cell cultures in shake flask, spinner flask and 1-250L bioreactor systems for the production of monoclonal antibodies, recombinant proteins and viral vectors.
- Preparation, formulation and filtration of cell culture media, feed supplements and reagents.
- Operate and maintains standard laboratory equipment and departmental specific equipment. Troubleshoots equipment within scope of experience.
- Assist with the analysis of data in Excel and DOE software, and assist in the preparation of data summaries
- Assist with the design, updating and maintenance of Process Development databases and experimental spreadsheets, supporting Upstream Cell Culture process development activities.
- Assist with the scale-up & technical transfer of cell culture processes and may author documents to support transfer to GMP Manufacturing.
- Ensure timely and accurate documentation in accordance with cGMP and MassBiologics' SOPs. Contributes to the development of improved documentation processes.
- Assist with writing protocols, project summaries and technical reports.
- Assist with troubleshooting, root cause analysis and identification of corrective actions to support Process Development or GMP Manufacturing equipment and process issues.
- Operate and maintain 1L-250L stirred tank bioreactor systems.
- Perform analytical biochemistry and molecular biology assays as well as microscopy and other laboratory testing as required.
- Keep accurate records in notebooks, organize and report results.
- Prepare written and oral reports for presentation to the development group and senior staff.
- Maintain reagent and equipment inventories, order supplies, cleaning of laboratory areas, hoods, incubators and group equipment.
- Exercise technical discretion in the design, execution and interpretation of experiments that contribute to project strategies.
- Maintain contact with outside vendors to discuss new products and maintenance of laboratory equipment.
- Trains junior personnel on techniques. May supervise lower level personnel.
- Perform additional job-related duties as required.
- Requires a Bachelor’s degree in Chemistry, Biochemistry, or related field with a minimum 2 years of relevant experience.
- Hands on experience with monoclonal antibody or viral vector production in mammalian cells.
- Ability to follow instructions precisely, recognize deviations, and recommend corrective action within scope of training.
- Possesses strong attention to detail, ability to maintain accurate records and excellent proofreading skills.
- Ability to troubleshoot within scope of training.
- Strong critical thinking, time management and organizational skills. Demonstrated ability to manage and prioritize multiple projects and consistently meet deadlines.
- Excellent written and verbal communication skills. Ability to communicate effectively with others.
- Ability to work effectively both independently and as a member of a team.
- Computer literate and proficient in MS Word, Excel and other relevant electronic systems.
- Occasionally projects require flexibility in work schedule to meet business needs.
ENVIRONMENTAL WORKING CONDITIONS:
- Job may require working with hazardous and infectious materials.
- Employees will receive appropriate training and be required to adhere to UMMS policies and procedures.
- Available to work evenings, weekends and holiday hours as required on a rotating basis.