Director, Manufacturing Sciences and Technology
Catalent
Summary
The Manufacturing Sciences and Technology (MS&T) department provides technical oversight and subject matter expertise for drug substance manufacturing at Catalent Madison. The team supports process and technology transfer (including mAbs, fusion proteins, mRNA, and emerging modalities), technical documentation, and drug substance lifecycle management. This role is client-facing and requires strong collaboration with internal teams and external partners.
Job description
Position Summary
The Manufacturing Sciences and Technology (MS&T) department provides technical oversight and subject matter expertise for drug substance manufacturing at Catalent Madison. The team supports process and technology transfer (including mAbs, fusion proteins, mRNA, and emerging modalities), technical documentation, and drug substance lifecycle management. This role is client-facing and requires strong collaboration with internal teams and external partners.
The Role
- Direct technical leadership for manufacturing and process transfers.
- Manage and review documentation, compile and assess data, and manage changes.
- Provide technical input for deviations, change controls, and CAPAs.
- Define and execute department strategy; recommend actions based on scientific data.
- Collaborate cross-functionally with Process Development, Manufacturing, QA/QC, Supply Chain, and Project Management.
- Analyze process data, identify trends, and present findings internally and to clients.
- Maintain a high-performing team through hiring, training, and development.
- Support process characterization, validation, and commercial readiness.
- Other duties as assigned.
The Candidate
- Bachelor's degree in a STEM discipline and 15+ years related experience, OR Master's degree in a STEM discipline and 12+ years related experience, OR Doctorate Degree in a STEM discipline and 8+ years related experience.
- 5+ years of leadership experience and proven ability to lead and develop high-performing teams.
- Strong technical knowledge of biologics manufacturing and GMP principles and experience with tech transfer, process validation, and commercial programs.
- Active participation in regulatory inspections and up to date on compliance requirements.
- Skilled in deviation investigations, CAPAs, SOPs, and batch record authoring.
- Knowledge of LEAN systems and continuous improvement methodologies.
- Excellent communication and presentation skills for technical and non-technical audiences.
Requirements
- Bachelor's degree in a STEM discipline and 15+ years related experience, OR Master's degree in a STEM discipline and 12+ years related experience, OR Doctorate Degree in a STEM discipline and 8+ years related experience
- 5+ years of leadership experience and proven ability to lead and develop high-performing teams
- Strong technical knowledge of biologics manufacturing and GMP principles
- Experience with tech transfer, process validation, and commercial programs
- Active participation in regulatory inspections and up to date on compliance requirements
- Skilled in deviation investigations, CAPAs, SOPs, and batch record authoring
- Knowledge of LEAN systems and continuous improvement methodologies
- Excellent communication and presentation skills for technical and non-technical audiences
Benefits
- 401(k) Matching
- Paid Time Off
- Medical, Dental & Vision
- Career Development
- Performance Reviews
Company overview
Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) that serves as a trusted partner to pharmaceutical, biotech, and consumer health companies worldwide. Founded on a legacy dating back to 1933, Catalent has evolved into a comprehensive drug development and delivery leader with over 40 global sites. The company specializes in providing end-to-end solutions spanning oral dose formulations, biologics, specialty products, and clinical supply services. Catalent's expertise includes formulation development, analytical services, commercial manufacturing, and advanced delivery technologies such as Zydis® fast-dissolve tablets and softgel technologies. With over 1,000 active development programs at any given time, the company launches more than 100 new products and line extensions annually and has supported half of all FDA approvals over the past decade. Catalent produces over 60 billion treatment doses per year, helping approximately 200 million patients annually. Headquartered in Tampa, Florida, the company employs more than 10,000 professionals globally who are dedicated to putting patients first and championing the missions that matter in healthcare innovation.