Scientist II, MS&T

Overview

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 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 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.

• Entry level

• Full-time

• Research, Analyst, and Information Technology

• Pharmaceutical Manufacturing