• Perform MS&T activities independently for pharmaceutical products including parenteral and nasal products for all new products from scale-up to commercialization and process improvement beyond commercialization.
• Understand the overall generic and new drug development processes, Agency requirements and CMC strategies.
• Understand and comply with all 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 independently 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 the company’s reputation with customers.  This role may also be a scientific team member for client calls regarding MS&T matters.
• Provide technical expertise and guidance to junior staff.
• Prepare project protocols, assess and identify deliverables. Review technical data, documents and proposals. This role might be asked to review and approve protocols and technical reports as requested by the Team Lead and as a Back-up to the Team Lead.
• Assist Team Lead in ensuring that adequate project resources are available, including personnel, equipment, supplies and facilities (if needed).
• Provide technical guidance independently on both commercial products after launch and development products through technical communications, memos, and reports.  This also includes helping the investigations team with problem solving and CAPAs on more technical issues.
• Trend data and look to continually achieve and meet specifications, providing Process Capability Analysis.
• Ensure batch records are written accurately in a manner that Operations can follow them and ensure Operations are trained in advance and feel confident in the process for engineering through commercial batches.
• Support any regulatory audits as assigned.
• Must have the ability to work in a team environment.
• Must ensure safety regulations and GDP/GMPs are adhered to in the laboratory and on the manufacturing floor.
• Must comply with all company policies.
• Flexibility in schedule is required based on business needs.
• Other duties, as assigned.

Experience

Required

Bachelor’s in Pharmaceutical Sciences, Formulation Chemistry, Chemical Engineering or similar degree AND a minimum of 5 years of related experience in MS&T or Product Development Master’s in Pharmaceutical Sciences, Formulation Chemistry, Chemical Engineering or similar degree AND a minimum of 3 years of related experience in MS&T or Product Development PhD in Pharmaceutical Sciences, Formulation Chemistry is preferred AND a minimum of 2 years of experience in MS&T or Product Development. 

Salary: 124-134.2K plus lump sum for simple relocation expenses, 3 weeks’ vacation, all health benefits, 1 week sick time.