Director, Manufacturing Sciences and Technology

Catalent Pharma Solutions • Madison, WI

4d • Onsite

About The Position

The Manufacturing Sciences and Technology (MS&T) department provides technical oversight and subject matter expertise for drug substance manufacturing at Catalent Madison. Our primary role is to act as an agile technical services team supporting process and technology transfer (including mAbs, fusion proteins, mRNA, and emerging modalities), technical documentation, and drug substance lifecycle management. This position supports technical leadership for GMP manufacturing and ensures effective process transfer to the facility. The role is accountable for documentation, data analysis, change management, and providing technical input for investigations, change controls, and CAPAs. It is client-facing and requires strong collaboration with internal teams and external partners to drive projects forward.

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 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.

Nice To Haves

• Demonstrable leadership experience at Catalent (including but not limited to participation in Catalent-sponsored leadership programs such as NGGL, GOLD, LEAD Now, GM Excellence, and GROW) may be considered in place of external experience.

Responsibilities

• 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.

Benefits

• Defined career path and annual performance review and feedback process
• Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives
• Generous 401K match and Paid Time Off accrual
• Medical, dental and vision benefits effective day one of employment

What This Job Offers

• Job Type: Full-time
• Career Level: Director