Supervisor I Clinical Supplies Packaging
Briefly summarize the primary purpose or function of the job (why does it exist?):
This position translates clinical supplies packaging documentation and/or oral packaging descriptions into Master Batch Records, Batch Production Records and packaging diagrams. The complexity of clinical trial packages and the packaging process require an explicit means of communication, such as diagramming or use of digital photographs to precisely define the package structure and facilitate the production process. This position will attend operational meetings and will be an integral part of the new clinical packaging processes. This position will be supervising Packaging Instruction Technicians. The position will liaise with the Clinical Supplies Packaging Manager (CSPM), the Packaging Operations Manager, Equipment Mechanics and Packaging and Labeling Technicians for the purpose of creating study data in NASCA Inventory Management System.
KNOWLEDGE AND SKILL REQUIREMENTS (Minimum requirements for assignment to this job.)
Knowledge And Skills:
- In-depth knowledge of GMP regulations.
- In-depth knowledge of pharmaceutical packaging, documentation, process technology and packaging equipment.
- Effective in communicating with peers, management, and subordinates.
- Must be detail-oriented with very good written communication and computer skills; PRS systems expert for the New Application for Supply Chain Activity (NASCA).
- The individual in this position must be creative, hands-on, detail-oriented, customer-driven, and capable of functioning in a high pressure, schedule-driven environment that requires accuracy.
Formal Education And/Or Experience Required:
- BS - BA degree with a minimum of 3 to 6 years of pharmaceutical experience to include at least 2 years of experience in the packaging of bulk pharmaceutical products or equivalent experience.
- Experience should include at least one year experience packaging investigational products.
- Computer skills; Microsoft WORD, EXCEL, VISIO (or similar program), Outlook.
Knowledge And Skills Desirable But Not Essential:`
- Supervisory experience.
- Experience with planning software such as MS Project and Visio, material flow management tools and Materials Requirements Planning (MRP).
- Ability to read, write and understand French.
PRINCIPAL DUTIES AND RESPONSIBILITIES (LIST 4-7).
Briefly describe the major duties and responsibilities for which the job is held accountable (please rank in order of importance.):
This position translates clinical supplies packaging documentation and/or oral packaging descriptions into the authoring Master Batch Records, Batch Production Records and packaging diagrams.
Documentation: Ensure documentation complies with regulations; local country requirements and / or European Union directive. Develop packaging instructions with the Clinical Supply Packaging Managers (CSPM) in accordance with cGMP regulations.
Staff: Ensure the CSPM support staff are fully trained to competently and efficiently perform all tasks and responsibilities required for the position.
Develop and oversee the guideline for format of packaging diagrams in the Master Batch Records.
Lead process improvement projects, particularly in the scope of the batch record creation and utilization.
Lead the eDemo Kit process for the department. This process is to depict (using a digital camera) the final Investigational Product.
Assist operations management with the interview and selection process for recruiting FTE and contract employees, particularly CSPM support.
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
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