Senior Manager, Formulation Sciences
Nuvalent, Inc.
full-time
Posted on:
Location Type: Remote
Location: Massachusetts • United States
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Salary
💰 $155,000 - $180,000 per year
Job Level
About the role
- Support drug product Process Validation activities, Scale up and post-approval changes (SUPAC) and routine commercial manufacturing at CDMOs.
- Identify critical process parameters based on the risk assessment and understanding the impact of material attributes and process parameters on critical quality attributes. Implement appropriate process controls to ensure delivery of consistent batch product quality.
- Draft, coordinate, execute validation protocols, perform data analysis, author/review and approve process validation reports with consistent and effective communication with other functions.
- Provide support to routine process validation studies, assisting with product technology transfers or lifecycle management changes such as process improvement, addition of secondary API and manufacture site change etc.
- Perform technical review of drug product manufacture deviations, change controls, perform process monitoring (manufacturing data summary and analysis, data presentation), perform activities for drug product lot release (assess deviations and process changes).
- Work closely with other team members and cross-functionally with quality assurance, analytical/QC, chemical development, supply chain, and project management team to achieve all project deliverables.
- Provide support for technical decision-making regarding cGMP compliance, validation strategy and regulatory pathway for SUPAC changes etc.
- Familiar with statistical analysis software, such as JMP.
- Perform process capability analysis, identify risk, and make recommendations for process improvement.
- Manage documentation, change controls, material inventory, product complaints, and deviation resolution at CDMOs.
- Represent the drug product group as a Subject Matter Expert to support audits and regulatory inspections.
- Support authoring the relevant technical sections of regulatory filings.
- Support late-stage validation and post-approval readiness activities and commercial manufacture activities within a virtual working environment.
Requirements
- PhD in pharmaceutics, pharmaceutical sciences, chemical engineering or related field with a minimum of 3+ years or MS with 6+ years /BS with 10+ years of industry experience.
- Proven track record on drug product process validation, scale up and manufacture for solid dosage form (tablets).
- Experience with QbD principles and DOE methodology preferred.
- Manage the outsourcing manufacturing activities at CDMO sites to meet CMC goals.
- Understanding of cGMP/ICH guidelines and the ability to apply them to development and manufacturing.
- Experience with solid dosage form (tablet) process development; exposure to late-stage validation is a plus.
- Ability to author and critically review relevant development reports as well as regulatory dossiers.
- Up to 25% travel is expected, both domestically and internationally.
Benefits
- medical, dental, and vision insurance
- 401(k) retirement savings plan
- generous paid time off (including a summer and winter company shutdown)
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
process validationscale upcritical process parametersdata analysisprocess capability analysisQbD principlesDOE methodologycGMP complianceregulatory filingssolid dosage form
Soft Skills
effective communicationtechnical decision-makingcollaborationproblem-solvingdocumentation management
Certifications
PhD in pharmaceuticsPhD in pharmaceutical sciencesPhD in chemical engineeringMS in pharmaceuticsMS in pharmaceutical sciencesMS in chemical engineeringBS in pharmaceuticsBS in pharmaceutical sciencesBS in chemical engineering