Senior Director - Manufacturing

Catalent • Madison, WI

3d • Onsite

About The Position

Senior Director – Manufacturing 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 Senior Director, Manufacturing is responsible for providing key leadership, direction, organization, management, monitoring, and cGMP compliance of the roles, activities, and proceedings of Manufacturing to ensure the successful, cost effective, timely, and safe processing of client projects. This position is responsible for all of cGMP Manufacturing and will serve as a member of the site leadership team.

Requirements

• Doctorate Degree in biological science, engineering, or related field with a minimum of 12 years of relevant experience, OR Masters Degree in biological science, engineering, or related field with a minimum of 15 years of relevant experience, OR Bachelors Degree in biological science, engineering, or related field with a minimum of 20 years of relevant experience.
• 8+ years of leadership experience.
• Exceptional people/operations leader with proven experience developing and inspiring teams, driving organization health and culture, and successfully navigating change management processes and principles.
• 10+ years manufacturing experience preferably in a manufacturing setting for biologics, under cGMP.
• Experience in pharmaceutical and/or biotechnology industry is required.
• Active participation in regulatory inspections and up to date on compliance requirements.
• 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.

Nice To Haves

• Working knowledge of end-to-end supply chain preferred including experience with S&OP, Inventory Management, and other associated Supply Chain disciplines.
• Thorough experience with clinical and commercial manufacturing.
• Direct experience working for or with contract manufacturing organization(s) strongly preferred.

Responsibilities

• Manages and directs all areas of cGMP Manufacturing, directing activities so that products are manufactured on-schedule and within quality standards and cost objectives.
• Responsible for processes associated with hiring, training, motivating, leading, developing and evaluating staff.
• Takes corrective action as necessary on a timely basis and in accordance with company policy.
• Ensures compliance with current federal, state, and local regulations.
• Consults with Human Resources Department as appropriate.
• Informs personnel of communications, decisions, policies, and all matters that affect their performance, attitudes, and results.
• Assists General Manager in the development and deployment of long and short-range strategy, planning, policies, programs, and objectives related to cGMP Operations.
• Develops the manufacturing strategy and deploys initiatives to align with site strategy.
• Establishes procedures for maintaining high standards of manufacturing operations to ensure that products conform to established client and Catalent quality and delivery standards.
• Achieves optimum employee levels with the least amount of overhead and raw material costs to meet annual budgetary plan.
• Other duties as assigned.

Benefits

• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Education Level: Ph.D. or professional degree