22 Feb
Upstream Development Scientist
Vacancy expired!
Job Description
- Responsible for performing upstream process development, including timely completion of small-scale experiments, scale-up, technology transfer and GMP floor support for programs that bring new biopharmaceutical products to pre-clinical, clinical and process validation manufacturing phases.
- Cell banking, cell expansion, bioreactor process, and harvest clarification process development, optimization, characterization, scale-up, and technology transfer to CMO’s and/or internal manufacturing facilities.
- Participate in cell culture process development, scale-up, and technology transfer activities.
- Applies basic knowledge from various technical areas, industry standards and practices, provides quality and productive output that is consistently timely, reliable and reproducible.
- Provide technical support and apply knowledge and execute experiments toward development and optimization of cell culture processes and in line with overall project plan and milestones under close supervision.
- Manage, operate, monitor, and troubleshoot bench-top bioreactors and related control systems.
- Documents data accurately in laboratory notebooks and completely as per established company guidelines/SOPs.
- Contributes to technical documents such as reports, protocols, internal presentations and regulatory filing documentation.
- Participate in and contribute to team meetings, including sub-teams, project teams, tech. transfer teams, and departmental meetings.
Qualifications
- BS (0-3 years) in Chemical/Biochemical Engineering/Biological Sciences or related discipline with relevant industry experience in upstream process development.
- Proven record of technical proficiency and troubleshooting.
- Proven ability to work in a fast-paced environment with demonstrated capacity to juggle multiple competing tasks and demands.
- Have working knowledge and experience with mammalian cell culture process development, process scale-up, tech. transfer, and GMP manufacturing support
- Have experience in design-of-experiment and the ability to analyze and interpret data collected
- Embrace and demonstrate teamwork/collaboration and the ability to communicate appropriately and effectively in both oral and written format
- Demonstrate ownership in executing bioreactor process development, tech. transfer, and manufacturing support
- Have the ability to proactively learn new technologies and manage changes in bioreactor process development and process scale-up
- Have experience working in GMP environment
- Experience with mammalian cell culture, experienceworking specifically with CHO cells is preferred
- Present issues and discussresults in group and team settings as needed.
- Apply fundamental engineering and/or biological principles to practical technical challenges
- Work closely with his/her supervisor and coworkers in managing projects.
- Provide input into the development of new cell culture processes.
Additional Information
Position is full-time, Monday - Friday 8:00am - 5:00pm. Candidates currently living within a commutable distance of Lexington, MAare encouraged to apply.
- Excellent full time benefits including comprehensive medical coverage, dental, and vision options
- Life and disability insurance
- 401(k) with company match
- Paid vacation and holidays
Vacancy expired!