Renaissance Lakewood, LLC · 2 weeks ago
Scientist II, MS&T
Renaissance Lakewood, LLC is involved in pharmaceutical product development, and they are seeking a Scientist II for MS&T activities. The role involves performing various tasks from scale-up to commercialization of pharmaceutical products, ensuring compliance with safety and quality practices, and fostering relationships with cross-functional teams.
Health CareManufacturingMedicalPharmaceutical
Responsibilities
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 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
Qualification
Required
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
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 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
Company
Renaissance Lakewood, LLC
Renaissance is a US-based contract development and manufacturing organization (CDMO) for pharmaceutical and biotech companies.
H1B Sponsorship
Renaissance Lakewood, LLC has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (5)
2024 (1)
2022 (2)
2020 (3)
Funding
Current Stage
Late StageTotal Funding
unknown2025-10-13Acquired
Recent News
2025-10-13
2025-10-13
Institutional Investor
2025-08-19
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