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.
The Role:
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.
The Candidate:
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.
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.
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.
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 (https://careers.catalent.com/us/en) 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 (https://cdn.catalent.com/files/legal/CCPA-Privacy-Notice-at-Collection-for-California-Employees-and-Applicants-English.pdf) .
