Director, Operations

Catalent Pharma SolutionsPhiladelphia, PA
Onsite

About The Position

Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually. Catalent's Philadelphia site serves as a center for the company's clinical supply services and oral solid dose development and manufacturing. The site specializes in providing comprehensive solutions for clinical trial materials, including packaging, labeling, and distribution. Catalent's Philadelphia site also offers expertise in oral solid dose formulation development, analytical testing, and commercial-scale manufacturing. The facility is equipped with advanced technology and adheres to stringent quality and regulatory standards to ensure the production of high-quality products. It plays a crucial role in supporting the pharmaceutical industry by providing efficient and reliable services for clinical supply and oral solid dose development and manufacturing. The Director of Operations is a hands-on, Senior Leadership position responsible for oversight, advancement and flawless execution of clinical and small-scale commercial packaging and labeling. The incumbent is responsible for developing and implementing strategies driving adherence to key functional and site metrics, ensuring manufacturing schedule adherence. Working together with Quality, Technical Operations, and Continuous Improvement the individual drives a client focus, solution oriented, lean culture. Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer and Catalent employee.

Requirements

  • Bachelor’s degree required; MS/MBA preferred.
  • Minimum 10 years of leadership experience in a pharmaceutical or similarly regulated industry, with at least 5 years managing manufacturing or equivalent.
  • Strong continuous improvement background with a proven track record of delivering sustainable results.
  • High drive for personal growth and strong business acumen.
  • Strong knowledge of SOPs and cGMPs and their purpose.
  • Ability to plan and manage multiple functions independently.
  • Results-driven with excellent collaboration and influence skills.
  • Excellent written, verbal, and interpersonal communication skills, including presentation abilities.
  • Proficient in MS Office Suite, electronic documentation, exception, and inventory systems.
  • Ability to influence and motivate teams in a matrix management environment and transition from tactical to strategic based on business needs.

Responsibilities

  • Establishes annual budgets, cost savings targets, and manufacturing goals to ensure financial and operational efficiency.
  • Develops and implements short- and long-term Continuous Improvement (CI) strategies to advance Packaging and Labeling operations by reviewing processes, identifying problem areas, and establishing action plans for improvement.
  • Works cross-functionally on Capital projects, ensuring all Operational Readiness requirements are met.
  • Interacts professionally with clients, contractors, and vendors to identify solutions that meet company objectives and foster positive relationships.
  • Provides ongoing coaching, mentoring, performance feedback, and development of staff to build a highly motivated, efficient, and effective team.
  • Assists with talent recruitment and leads a team dedicated to achieving high performance standards.
  • Creates standard procedures that facilitate operator performance and ensure compliance with regulatory standards.
  • Ensures all Manufacturing activities comply with cGMP standards, maintaining the highest level of quality and safety.
  • Leads site operations meetings with clients, including preparing presentation materials and conducting site tours to showcase capabilities.
  • Interacts with Government agencies (FDA, TTB) to ensure the site complies with all applicable regulations and standards.

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
  • Tuition Reimbursement
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