Scientist II - MS&T

Renaissance Lakewood, LLC


Date: 2 weeks ago
City: Lakewood, NJ
Contract type: Full time
  • Perform MS&T activities with limited supervision for pharmaceutical products, including parenteral and nasal products, for all new products from scale-up through commercialization, as well as process improvements beyond commercialization.
  • Continue to grow in understanding the overall generic and new drug development processes, Agency requirements, and CMC strategies.
  • Understand and comply with all the Renaissance safety, environmental, and quality practices and procedures as outlined in organization/departmental guidelines and SOPs, as well as applicable federal, state, and local regulations. Ensure all department SOPs are in place and followed.
  • Participate with supervision in the progress of project work with follow-ups, meeting timelines, and providing appropriate technical info to the support team.
  • Identify, develop, and foster strong working relationships with cross-functional teams, external customers, and support initiatives that continually enhance Renaissance's reputation with customers. This role may also be a scientific team member for client calls regarding MS&T matters.
  • Prepare project protocols, assess and identify deliverables with limited supervision. Review technical data, documents, and proposals.
  • Provide technical guidance with limited supervision on both commercial products after launch and development products through technical communications, memos, and reports.
  • Learn to trend data and look to continually achieve and meet specifications, providing Process Capability Analysis.
  • Ensure batch records are written and accurate in a manner that Operations can follow them, and ensure Operations are trained and feel confident in the process for commercial batches.
  • Support any regulatory audits as assigned.
  • Must have the ability to work in a team environment.
  • Must comply with all company policies.
  • Flexibility in schedule is required based on business needs.
  • Other duties, as assigned.

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