Director, Operations - Chelsea, United States - Catalent

Catalent
Catalent
Verified Company
Chelsea, United States

3 weeks ago

Mark Lane

Posted by:

Mark Lane

beBee recruiter
Description

Position Summary


The Director, Operations is a hands-on, Senior Leadership position responsible for the oversight, advancement and flawless execution of early to commercial stage Spray Drying, Filling and Packaging functional groups.

The incumbent is responsible for developing and implementing strategies driving manufacturing schedule adherence to meet in full, on time delivery of product to clients.

Working together with Quality and Technical Operations, the individual drives a client focus, solution-oriented, continuous improvement, lean culture.


The Role

  • Establishes annual budgets, cost savings targets and manufacturing goals.
  • Develops and implements short
- and long-term CI strategies to advance Spray Drying, Filling and Packaging operations, by reviewing processes, identifying problem areas and establishing action plans for improvement.

  • Works crossfunctionally of Capital projects ensuring Operational Readiness requirements are met.
  • Ensures the timely procurement of all materials necessary to meet production demand.
  • Interacts with clients, contractors and vendors in a professional manner to identify solutions to meet company objectives.
  • Provides ongoing coaching, mentoring, performance feedback and development of staff.
  • Assists with talent recruitment and leads a highly motivated, efficient, and effective team.
  • Creates standard procedures that facilitate operator performance and compliance.
  • Leads site meetings with clients, including presentation materials and site tours.
  • Interacts with Government agencies (FDA, TTB) to ensure site compliance with applicable regulations.
  • Operations SME on SAT, IOQ, PQ PPQ and Product Development documents for approval.
  • Overseas departmental deviations, investigations, change controls, and CAPAs.
  • Bachelor's degree required. MS/MBA preferred.
  • Minimum of 10 years of experience working in a pharmaceutical or similarly regulated industry required. Minimum of 5 years of direct experience managing manufacturing and operating at a 24h/7d schedule or equivalent is required. A strong continuous improvement background with a solid track history of delivering sustainable results.
  • Strong knowledge of manufacturing technologies particularly encapsulation, spray drying and blister sealing.
  • Strong understanding of GMP compliance as it pertains to clinical through commercial manufacturing.
  • Knowledge of shipping and receiving techniques and processes.
  • Knowledge of cGMP regulations as they pertain to final dosage manufacturing and primary packaging.
  • Must be proficient in MS Office Suite including PowerPoint, electronic documentation, exception and inventory systems.
  • Excellent written, verbal and presentation skills.

Why You Should Join Catalent

  • Defined career path and annual performance review and feedback process
  • Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives
  • Dynamic, fastpaced work environment
  • Generous 401K match and Paid Time Off accrual
  • Medical, dental and vision benefits effective day one of employment
  • Tuition Reimbursement
  • GymPass program to promote overall physical wellness

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.

Catalent is committed to the health and safety of its employees, visitors and the customers and patients we serve.

As a result of the global pandemic, we have modified many of our recruitment and on-boarding processes to maintain everyone's safety.

The Human Resources teams will communicate all necessary safety processes and procedures throughout each stage.

personal initiative. dynamic pace. meaningful work.

Visit Catalent Careers to explore career opportunities.

Catalent is an Equal Opportunity Employer, including disability and veterans.

Important Security Notice to U

S Job Seekers:
California Job Seekers can find our California Job Applicant Notice HERE.
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