Scientist II, MS&T - Renaissance Lakewood LLC

The purpose of MST Scientist II position is to perform MS&T functions with limited supervision such as process development, scale-up, technology transfer, commercialization and product lifecycle advancements.  This individual will ensure he/she is trained in areas related to quality by design, scale-up, technology transfer, manufacturing scale-up and process improvement. Provide technical knowledge, influence and thorough planning to drive for timely and appropriate results with limited supervision.

• 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.

Bachelor's Degree in Pharmaceutical Sciences, Formulation Chemistry, Chemical Engineering or similar degree AND a minimum of 3-5 years of related experience in MS&T or Product Development

Master's Degree in Pharmaceutical Sciences, Formulation Chemistry, Chemical Engineering or similar degree AND a minimum of 1-3 years of related experience in MS&T or Product Development

PhD in Pharmaceutical Sciences, Formulation Chemistry is a plus.