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Director, Operations - Chelsea Massachusetts
Company: Disability Solutions Location: Chelsea, Massachusetts
Posted On: 05/04/2024
Position SummaryThe 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
- 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
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