DAS Project Director, Manufacturing Operations
Catalent Pharma Solutions - Morrisville, NC

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Catalent Pharma Solutions (a Blackstone Group company) is a leading Drug Development, Advanced Delivery Technology and Supply partner to the global pharmaceutical industry. A Fortune 1000 company, with over 20 locations on 5 continents, we partner with 90 out of the top 100 pharmaceutical companies and 44 of the top 50 biotech firms, as well as thousands of small innovator companies.

Responsible for the management of all manufacturing activities for the sterile commercial manufacturing business unit.

Directly responsible for managing supervisors and coordinating activities for the business unit.

Responsible for ensuring and enforcing compliance with cGMPs, corporate and site-specific policies, and procedures.

Will serve as the representative for the business unit to all internal support groups and aid the Customer Service Representative with external customers.

Responsible for maintaining and reporting metrics to evaluate the performance of the business unit.

Responsible for the professional development and mentoring of direct reports.

Responsible for the succession planning and in-depth cross-functional training of all members of the business unit.

Directly responsible for production schedule adherence.

Directly responsible for the operational and preventative maintenance of all processing equipment assigned to the business unit.

Responsible for all safety incidents and quality deviations that occur and responsible for the thorough investigation and timely reporting of such.

Must become fluent in all functional areas of responsibility in the business unit.

Must share resources with other business units as needed and when available.

Must develop and manage budget and performance objectives/evaluations.

Must perform Validation protocol and batch record review/approval.

Participate in technical transfer and validation activities affecting the department.

Interact with clients and regulatory agents during audits.

Qualifications

Education or Equivalent:
BS degree in scientific field or business required.

Minimum of 10 years directly applicable experience in the industry.

Experience or Equivalent:
Minimum required to perform job.

Minimum of 10 years directly applicable experience in the industry.

Knowledge, Skills, and Abilities Requirements:
Excellent communication skills both written and oral.

Prior managerial experience required.

A full complement of business computer literacy skills (e.g., word processing, spreadsheets, database software etc.) is preferred.

Catalent Pharma Solutions - 19 months ago - save job - block
About this company
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Catalyst + talent = Catalent. At least, that's the brand Catalent Pharma Solutions is using to try to ensure its customers'...