Director, Operations

Catalent Pharma Solutions

Director, Operations

Chelsea ,

Massachusetts

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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 cross-functionally 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.
Assures all activities of Manufacturing apply the appropriate level of cGMP 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.
The Candidate
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, fast-paced 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 (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 [email protected] . 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 [email protected] 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) .

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