Specialist Clinical Supplies Packaging
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The Clinical Supplies Packaging Manager (CSPM) I position is required to ensure that quality packaged investigational supplies are available as agreed to support clinical operations. This role must interface with other groups in Clinical Supply Chain Operations (Packaging and Distribution Operations, Scheduling, etc.) to develop operational plans and deliver to meet the overall program objectives. This role must maintain a strong liaison with all departmental support groups, particularly with those involved in the design, budgeting, planning, production and release of clinical supplies.
CSPM must coordinate with Packaging Operations, the Project Leaders, Trial Supplies Operations Managers and Clinical Supply Chain Managers to ensure study package and labeling feasibility is conducted to meet the customer’s requirements and ensure product availability for worldwide distribution. The CSPM role coordinates and leads the process to produce and make available fit-for use investigational product within the global Clinic Supply Chain Operations.
The complexity of the clinical trials packaging process requires the individual in this position to be clinical supplies packaging operations project oriented. The position requires an incumbent who is hands-on, focused, detail oriented, customer driven, and capable of functioning in a high pressure, schedule driven environment.
This position will be required to deliver supply chain efficiency through continued business process improvement.
This position requires the individual to have successfully performed the above job.
KNOWLEDGE AND SKILLS:
- An expert in all aspects of clinical labeling and packaging, cGMPs and other regulatory requirements pertaining to clinical supplies.
- Demonstrated project management skills.
- Must possess experience managing multiple, complex clinical supplies projects simultaneously.
- Must possess strong problem-solving skills using creative and innovative thought.
- Must be customer focused Must have attention to detail.
- Excellent organizational, leadership, written and oral communication skills.
- Demonstrated excellence in working with inventory systems (i.e. Rockwell automation, SAP), MS Word, Excel and flow diagramming software required.
MAJOR DUTIES & RESPONSIBILITIES:
- Ensure that quality packaged investigational supplies are available on the agreed availability date.
- Works with management to develop and support the global harmonization of process and practice in the Clinical Supplies SCP. Ensure the harmonized use and development of Clinical Supplies SCP’s standard catalogue of packaging solutions.
- Works and or leads in a team setting and must be able to provide clinical supplies team members with technical solutions for clinical packaging design based on protocol requirements.
- Provides technical expertise on packaging solutions. Supports harmonized use and development of innovative solutions for CS SCP’s standard catalogue of packaging solutions. This should include development of packaging solution approaches that support the expanded use of automation by operations.
- Work with Package Instructions group and ensure delivery of a compliant batch record to adequately document, direct and control the production of quality investigational product.
Formal Education and/or Experience Required:
- Bachelor’s degree in Pharmacy, Health Science, Biology/Chemistry, Engineering or Business Administration.
- Minimum of 6 years in the pharmaceutical industry or equivalent experience.
- Minimum of 4 years’ experience in a clinical supply chain working closely with a production group in a team environment.
- Demonstrated management, leading teams and decision-making skills required.
Knowledge and Skills Desirable but Not Essential:
- Experience with planning software such as MS Project, material flow management tools and Materials Requirements Planning (MRP).
- Expert knowledge of package design and materials; label generation software; batch record design.
- Ability to read, write and understand French.
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.
At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.
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