Senior Manager, Production

Catalent Pharma Solutions; Winchester (KY); On-site; USD 150,000 - 190,000; Full time

Benefits offered by this job

Medical, dental, and vision benefits

Tuition Reimbursement

Onsite events and programs

Job summary

Catalent Pharma Solutions in Winchester, KY seeks a Senior Manager, Production to lead manufacturing operations, ensuring on-time delivery, quality, and cost targets. The role drives continuous improvement, conducts audits, and collaborates across functions to optimize processes and staffing.

Responsibilities include overseeing daily performance, maintaining cGMP compliance, and leading technical scale-up with process development teams.

Qualifications

• Bachelor's degree required.
• 3+ years supervisory or management experience preferred.
• Strong knowledge of cGMP, FDA, and DEA guidelines.

Responsibilities

• Oversee daily performance against standards and schedules, resolving workflow issues for 24/7 operations.
• Collaborate with Materials Management to ensure inventory integrity and timely material flow.
• Ensure cGMP compliance and safety within Manufacturing; maintain tour-ready facility.
• Lead audits, CAPA, and regulatory interactions with agencies/customers.
• Train operators on SOPs and regulations; verify accurate batch records.

Skills

People management

Leadership

cGMP knowledge

Regulatory compliance

Budgeting/Cost control

Process improvement

Education

Bachelor's degree

Tools

Microsoft Office

Job description

**Senior Manager, Production****About Site**Catalent’s Winchester, KY site is the company’s flagship U.S. manufacturing location for large‐scale oral solid dose forms, operating from a 180,000‐square‐foot facility with fully integrated development and analytical services. The site specializes in complex and controlled‐release oral dose technologies, supporting product development, technology transfer, and commercial manufacturing across pharmaceutical and consumer health programs. Winchester has a long commercial manufacturing track record, having launched 100+ products and producing billions of tablets and capsules annually, making it a critical site within Catalent’s oral dose network.**Position Summary**We have an opportunity for a Senior Manager, Production to join our team and lead operations to deliver high-quality products on time and within budget. This role ensures compliance with cGMP standards, safety regulations, and operational excellence. You will manage departmental success through strategic leadership, collaboration, and continuous improvement. This position plays a key role in driving performance, efficiency, and innovation within the manufacturing environment.Shift: Monday - Friday 8 AM -5 PM Location: Winchester, KY 100% Onsite**The Role*** Oversee daily performance against established standards and schedules, resolving workflow and technical issues to support 24/7 operations.* Liaise with support functions to ensure efficient schedules and quality products, managing material, staff, and information flow.* Interface with Materials Management and warehouse staff on raw material inventory control issues.* Collaborate across functions to achieve shared goals.* Ensure compliance with cGMP and safety regulations within the Manufacturing department.* Maintain the facility in a “tour ready” state, ensuring proper flow, cleaning, and zone concepts.* Manage audits, corrective action plans, and interactions with governmental agencies and customers.* Ensure operators are trained and follow standard operating procedures and regulations.* Verify batch records are complete and accurate the first time.* Work with process development and customers for process scale-up and optimization.* Troubleshoot processing, equipment, or utility issues.* Define and implement Corrective/Preventive Action measures for audits and deviations, meeting commitments on time.* Promote Operational Excellence, Six Sigma, and Lean methodologies, including running Kaizen Events.* Provide technical expertise during development of new manufacturing platforms and products.* Manage screening, hiring, training, evaluation, and development of operations staff.* Recruit and develop top talent, fostering engagement and a culture of continuous improvement.* Oversee activities of Supervisors and material expeditors, providing guidance as needed.* Identify and maintain staffing needs, working with HR and training teams to build a skilled workforce.* Make personnel recommendations on staffing, wages, and performance reviews.* Manage manufacturing staff deployment, including selection, evaluation, and grievance resolution.* Assist in developing strategic operational plans.* Participate in managing the P&L impact of operations, including cost center spending, headcount, and budgeting.* Perform other duties as required to support high performance.**The Candidate**Minimum Requirements* Bachelor’s degree and 3 years of prior supervisory or relevant management experience.* Ability to create and work within an operating plan framework and budget.* Thorough knowledge of equipment and processes used in the facility and within the pharmaceutical industry.* Strong understanding of cGMP, FDA, and DEA guidelines and their application.* Knowledge of Solid Dosage manufacturing.* Excellent computer skills.* Ability to manage priorities and projects effectively, with strong communication and people management skills.* Skills in diplomacy, negotiation, team building, independent work, coaching, and delegation.* Capability to work in a matrix organization and think systematically.* Proficient in English verbal and written communication, with excellent presentation skills.* Proficient in Microsoft Office applications (Word, Excel, PowerPoint).* Ability to work effectively under pressure to meet deadlines.* Individual may be required to sit, stand, or walk for extended periods.* Specific vision requirements include reading written documents and frequent use of a computer monitor.* 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.Preferred Skills & Background* Experience in pharmaceutical or biotech manufacturing.* Operational excellence certification preferred.**Why You Should Join Catalent*** Positive and fast-paced working environment focused on continuous improvement and innovation.* Competitive Paid Time Off plus 8 paid holidays.* Medical, dental, and vision benefits effective day one of employment.* Tuition Reimbursement to help you finish your degree or earn a new one.* Engaging site-based activities such as NCAA Basketball Brackets, Golf Scrambles, and Annual Onsite Pet Adoption Events.* Employee Resource Groups promoting Diversity and Inclusion.* Green initiatives and community engagement, including Adopt-a-Highway Clean-up.* Defined career path with annual performance reviews and growth opportunities.* WellHub program supporting physical and mental wellness.* Exclusive discounts through Perkspot from over 900 merchants.**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.