About this role
• 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.