VP, MS&T
BioCryst Pharmaceuticals, Inc.
6 months ago
Remote friendly (North Carolina, United States)
United States
Medical Affairs
Vice President, Manufacturing Sciences & Technology (MS&T)
Responsibilities:
- Provide enterprise-level leadership for MS&T across the portfolio, aligning technical execution with strategic growth objectives and ensuring readiness for scale-up and increased manufacturing complexity.
- Lead MS&T strategy and operations for biologics and small molecule programs from late clinical development through regulatory submissions, licensure, and commercial launch.
- Oversee technical aspects of external manufacturing: process development, process validation, technology transfer, and routine technical support.
- Serve as primary MS&T lead for health authority interactions (FDA, EMA, and other global agencies), owning manufacturing strategies, control rationale, and lifecycle plans.
- Direct preparation, review, and defense of CMC regulatory submissions (INDs, BLAs, MAAs, briefing packages, Module 3) and ensure scientific rigor and regulatory defensibility.
- Partner cross-functionally with Process Development, Analytical Development, Quality, Regulatory Affairs, Commercial Operations, and Manufacturing & Supply for end-to-end technical and regulatory alignment.
- Design and implement operating models, governance, and talent strategies to scale MS&T for 2–5x growth (organizational design, recruitment, retention, leadership development).
- Establish risk management frameworks consistent with ICH Q8/Q9/Q10 and Quality by Design.
- Identify and implement best practices and technical innovations in process validation, technology transfer, and process optimization.
- Oversee data tracking and trending programs for process performance monitoring and compliance.
- Support preparation/review of technical and manufacturing documentation (protocols, process descriptions, batch records, SOPs, technical reports) with QA/QC.
Qualifications:
- Bachelor’s degree required in biochemical engineering, chemical engineering, pharmaceutical sciences, biotechnology, or related field; Master’s or PhD preferred.
- 15+ years biopharmaceutical industry experience, including 10+ years in biologics development and 5+ years in small molecule/solid oral dosage development.
- Demonstrated leadership of MS&T or Technical Development supporting original BLA submissions (not supplements only).
- Proven ownership of CMC regulatory strategy (IND/BLA/MAA authorship, defense, lifecycle management).
- Extensive experience in upstream, downstream, drug product development, process validation, technology transfer, and external manufacturing management.
- Documented experience scaling technical organizations through 2–5x growth.
- Deep understanding of biologics and small molecule manufacturing processes, control strategies, and regulatory requirements.
- Strong planning, management, critical thinking, problem-solving, and communication skills; ability to interface across organizational levels and external contract organizations.
Responsibilities:
- Provide enterprise-level leadership for MS&T across the portfolio, aligning technical execution with strategic growth objectives and ensuring readiness for scale-up and increased manufacturing complexity.
- Lead MS&T strategy and operations for biologics and small molecule programs from late clinical development through regulatory submissions, licensure, and commercial launch.
- Oversee technical aspects of external manufacturing: process development, process validation, technology transfer, and routine technical support.
- Serve as primary MS&T lead for health authority interactions (FDA, EMA, and other global agencies), owning manufacturing strategies, control rationale, and lifecycle plans.
- Direct preparation, review, and defense of CMC regulatory submissions (INDs, BLAs, MAAs, briefing packages, Module 3) and ensure scientific rigor and regulatory defensibility.
- Partner cross-functionally with Process Development, Analytical Development, Quality, Regulatory Affairs, Commercial Operations, and Manufacturing & Supply for end-to-end technical and regulatory alignment.
- Design and implement operating models, governance, and talent strategies to scale MS&T for 2–5x growth (organizational design, recruitment, retention, leadership development).
- Establish risk management frameworks consistent with ICH Q8/Q9/Q10 and Quality by Design.
- Identify and implement best practices and technical innovations in process validation, technology transfer, and process optimization.
- Oversee data tracking and trending programs for process performance monitoring and compliance.
- Support preparation/review of technical and manufacturing documentation (protocols, process descriptions, batch records, SOPs, technical reports) with QA/QC.
Qualifications:
- Bachelor’s degree required in biochemical engineering, chemical engineering, pharmaceutical sciences, biotechnology, or related field; Master’s or PhD preferred.
- 15+ years biopharmaceutical industry experience, including 10+ years in biologics development and 5+ years in small molecule/solid oral dosage development.
- Demonstrated leadership of MS&T or Technical Development supporting original BLA submissions (not supplements only).
- Proven ownership of CMC regulatory strategy (IND/BLA/MAA authorship, defense, lifecycle management).
- Extensive experience in upstream, downstream, drug product development, process validation, technology transfer, and external manufacturing management.
- Documented experience scaling technical organizations through 2–5x growth.
- Deep understanding of biologics and small molecule manufacturing processes, control strategies, and regulatory requirements.
- Strong planning, management, critical thinking, problem-solving, and communication skills; ability to interface across organizational levels and external contract organizations.