Scientist II, MS&T

Renaissance Lakewood•Lakewood, NJ

About The Position

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.

Requirements

Ability to work in a team environment.
Must comply with all company policies.
Flexibility in schedule is required based on business needs.

Responsibilities

Perform MS&T functions with limited supervision, such as process development, scale-up, technology transfer, commercialization, and product lifecycle advancements.
Ensure training 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.
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.
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.
Work in a team environment.
Comply with all company policies.
Other duties, as assigned.