MS&T Scientist II, New Jersey
- 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 enhance Renaissance’s reputation with customers continually. This role may also be a scientific team member for client calls regarding MS&T matters.
- Prepare project protocols and assess and identify deliverables with limited supervision. Review technical data, documents, and proposals.
- Provide technical guidance with limited supervision on 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.
Required
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.
Salary: 89-96K plus lump sum for simple relocation expenses