Perform MS&T activities with limited supervision for pharmaceutical products including parenteral and nasal products for all new products from scale-up to commercialization and process improvement 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 outlines 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 good working relationships with cross-functional teams, external customers and support initiatives required to 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.
Numbers & Facts
Location
Lakewood, New Jersey
Website
https://www.renpharm.com/careers/jobs
Skills
Biotech and Pharmaceuticalunmatched
Cross-Functionalunmatched
Drug Developmentunmatched
Federal Laws and Regulationsunmatched
Green Businessunmatched
Process Analysisunmatched
Process Capabilityunmatched
Process Improvementunmatched
Product Managementunmatched
Product/Service Launchunmatched
Protocol Analysisunmatched
Regulationsunmatched
Safety/Work Safetyunmatched
Standard Operating Procedures (SOP)unmatched
State Laws and Regulationsunmatched
Team Playerunmatched
Technical Leadershipunmatched
Technical Writingunmatched
Time Managementunmatched
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