Director, Manufacturing Sciences and Technology

Director, Manufacturing Sciences and Technology Position Summary: • 100% on-site Working for Catalent Biologics is an opportunity to join an entrepreneurial team. Catalent Biologics is making significant investments in people and capabilities. This is a unique opening to join a small, fast-growing business, backed by a private company. People joining our team will have the opportunity for career development as our business continues to grow and expand. Catalent-Madison employees are helping to improve future patient outcomes by working on products that are designed to treat COVID-19, cancer, various autoimmune, fibrotic and blood disorders, HIV, diabetes, heart and lung diseases as well as Alzheimer’s. 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. 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. • 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. Why You Should Join Catalent: • Defined career path and annual performance review and feedback process • Diverse, inclusive culture • Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives • Dynamic, fast-paced work environment • Community engagement and green initiatives • Generous 401K match and Paid Time Off accrual • Medical, dental and vision benefits effective day one of employment Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference. personal initiative. dynamic pace. meaningful work. Visit Catalent Careers to explore career opportunities. Catalent is an Equal Opportunity Employer, including disability and veterans. If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com . This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process. Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you. Important Security Notice to U.S. Job Seekers: Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond— it is a fraudulent request. Please forward such requests to spam@catalent.com for us to investigate with local authorities. California Job Seekers can find our California Job Applicant Notice HERE . Volunteer Work Disclosure: Applicants for employment in Massachusetts may include in their employment history any verified work performed on a volunteer basis. Massachusetts Lie Detector Test Notice: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law may be subject to criminal penalties and civil liability. Consistent with Massachusetts law, Catalent does not require or administer lie detector tests as a condition of employment or continued employment.