Product Development Scientist

Department: R&D

Reports to: Manager Product Development

Strategic Focus Areas:

  • Product development with a focus on pharmaceutical, biological, and injectable biological therapies
  • Perform product development-related testing
  • Maintain all activities to meet project timelines
  • Maintain effective collaboration with internal colleagues and external vendors to meet corporate objectives and drive business results
  • Maintain cost discipline within assigned programs
  • Develop new intellectual property


Specific Tactical Responsibilities:

  • Design and develop molecular and cellular biology-based assays to screen established products and product candidates
  • Collaborate internally as required to facilitate assay and test method validation and transfer to Quality Control or other functional areas
  • Collaborate with external stakeholders to coordinate appropriate pre-clinical testing
  • Participate in project teams throughout all stages of product development
  • Maintain up-to-date records of laboratory activities and test results
  • Maintain a familiarity with good laboratory practices and emerging techniques and technologies
  • Review literature, FDA guidance documents ISO and ASTM standard, etc. to maintain design control documentation
  • Author, review and revise testing protocols, reports, and other documents
  • Participate in root cause analyses of technical issues in collaboration with other members of the R&D group
  • Participate in product development team meetings and execute associated deliverables
  • Responsible for other duties and projects as assigned


Required Qualifications:

  • Ph.D. in the life sciences and at least 3 years post-doctoral work
  • 3+ years laboratory experience with a focus on cell and molecular biology
  • 2+ years experience with the structure-process-property relationship for stem cells and biomaterials
  • 3+ years experience in cell culture


Desired Experience, Knowledge and Skills:

  • Demonstrated experience writing, editing and reviewing technical documents
  • Demonstrated ability to understand, document and resolve complex technical issues
  • Strong written and verbal communication skills and excellent interpersonal skills
  • Ability to work autonomously and handle multiple projects

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