Janssen Research & Development, LLC, a Johnson & Johnson Company, is hiring a Principal Scientist, API Upstream Process Development to be located in Malvern, PA.
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The successful candidate for this position will contribute to upstream process development within the therapeutic protein process development group in Malvern, PA. The candidate will be responsible to lead and perform upstream process development studies including:
- Drive optimization of cell culture media and feed platform
Lead upstream process development sub-teams in support of clinical asset CMC development including:
- establishing and communicating development plan
Overseeing process development activities including:
- study designs
- study execution
- tech transfer/ PF2P
- scale up/ scale down
- process characterization
- control strategy development
- process validation (laboratory and manufacturing-scale studies)
- overseeing process risk assessments,
Driving documentation of technical program including writing and reviewing:
- technical reports
- campaign summary reports
- investigation memos
- process flow documents
- writing and reviewing API upstream granules for regulatory filings.
Additional duties include:
- Lead and participate in scientific investigations and trouble-shoot process issues that arise during development, technology transfer, or scale-up
- Contribute to regulatory filings
- Participate in technology development
The candidate is expected to work effectively in a team environment and well as contributing individually to meet project objectives and timelines. Other duties will be assigned, as necessary.
- A PhD in Biological Sciences or Cell Biology or Biochemistry or Chemical Engineering or related field with at least 6 years of relevant experience OR a Masters with at least 12 years of experience performing progressively advanced duties at the Senior Scientist level OR equivalent training and relevant experience is required
Experience and Skills:
- Knowledge of and hands-on experience with cell culture media development and/or optimization is required
- Knowledge of and hands-on experience leading large molecule drug substance (API) upstream manufacturing process development is required
- Experience working across development and supply chain in the development and implementation of manufacturing processes is required
- Candidate that is highly organized and capable of managing/pursuing multiple projects is required
- Good written and verbal communication skills are required
- Experience maintaining written records of work in the form of laboratory notebooks (paper or electronic) is required
- The ability to report data, present findings to management is required
- Experience with team-based collaborations and direct management of staff is required
- Occasional domestic or international travel will be required
- Familiarity with and hands-on experience with analytical methods typically used in the manufacture and characterization of recombinant proteins is preferred
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
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