Principal Researcher, Upstream Development
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The Opportunity
Description
- Execute upstream small scale model development studies and then generate qualification protocols and execute upstream small scale model qualification including data collection, analysis, and technical report writing.
- Generate characterization protocols and execute studies for proven acceptable range including data collection, analysis and technical report writing.
- Generate process performance qualification protocols for upstream commercial scale process and coordinate process execution including data collection, analysis, and technical report writing.
- Support process deviation by executing studies as appropriate.
- Support upstream process technology transfer to CMO as appropriate.
- Order supplies, manage samples, discard expired reagents and perform housekeeping and other laboratory maintenance tasks to assure laboratories are continuously maintained in a safe, orderly and efficient condition.
- Participate in process improvement evaluation.
- Interact cross-functionally with Downstream Process Development, Operations, Facilities, R&D, Quality Assurance, Quality Control, QC Biochemistry, and other internal and external functions to support successful product development.
Our Client
Our client is an award-winning clinical development company. Improving lives globally with 20+ years experience in clinical research and strategic resourcing. Elevating results with proven strategies, comprehensive solutions, and customized delivery models.
Serving pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations.
Strong relationships provide you connections and access to great opportunities. Industry expertise sets you up for success with helpful insights, career coaching, and professional training. Grow and learn while you put your skills to work.
Experience Required for Your Success
- BS or MS in (Bio)Chemical Engineering or Engineering or Biological Sciences or equivalent job experience/degree is strongly preferred
- Minimum of 8 years (BS) or 5 years (MS) practical scientific experience preferably in the mammalian cell culture and harvest process
- Excellent aseptic skills and broad cell culture bioreactor and biochemistry analytical knowledge and experience
- Technical writing, laboratory notebook, and data analysis skills
- Experience with Process Validation/Process Characterization at lab or commercial scale
- Detail-orientated, excellent trouble-shooting aptitude
- Strong time management skills and capability of executing multiple projects simultaneously
- Capable of response promptly to company objective re-prioritization
- Strong interpersonal skills, team-orientated, good written and verbal communication skill is required
- Familiarity with cGMP and DOE statistic experimental design and data analysis is a plus
What Do You Think?
Does your experience reflect what it takes to be successful in this role? Do the work and challenges get you excited about what's possible?
