Scientist II, MS&T

Renaissance Lakewood • Lakewood, NJ

1d

About The Position

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.

Requirements

• Ability to work in a team environment.
• Compliance with all company policies.
• Flexibility in schedule based on business needs.

Nice To Haves

• Understanding of overall generic and new drug development processes.
• Knowledge of Agency requirements and CMC strategies.
• Experience with parenteral and nasal products.
• Ability to trend data and perform Process Capability Analysis.
• Experience in preparing batch records and training operations staff.

Responsibilities

• Perform MS&T activities with limited supervision for pharmaceutical products including parenteral and nasal products from scale-up to commercialization and process improvement.
• Understand and comply with safety, environmental, and quality practices and procedures.
• Ensure all department SOPs are in place and followed.
• Participate in project work with follow-ups, meeting timelines, and providing technical information.
• Foster good working relationships with cross-functional teams and external customers.
• Act as a scientific team member for client calls regarding MS&T matters.
• Prepare project protocols and identify deliverables with limited supervision.
• Review technical data, documents, and proposals.
• Provide technical guidance on commercial and development products.
• Trend data and provide Process Capability Analysis.
• Ensure batch records are written accurately and operations are trained on processes.
• Support regulatory audits.
• Work in a team environment.
• Comply with all company policies.
• Demonstrate flexibility in schedule based on business needs.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: No Education Listed