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Senior Manager of Supply Chain

Cambridge, MA 02142

Posted: 08/23/2024 Employment Type: Contract To Hire Job Category: Procurement/Supply Chain Job Number: 611266 Is job remote?: No Country: United States

Job Description

Target PR Range: 70-80/hr
*Depending on experience

Summary of Position:
The Senior Manager of Supply Chain has the responsibility of managing the supply of investigational product(s) (IP) for early and late-stage clinical trials as well as aid in commercial supply chain activities. This involves creating supply-demand plans based on the clinical study requirements and outsourcing to external vendors for the labeling, packaging, and distribution of the IP. The primary goal is to meet the clinical demand while ensuring compliance with regulations. This position will work closely with Clinical Operations, Clinical Supply Chain, Quality Assurance, Regulatory Affairs, and third-party CMOs. Strong cross-functional team leadership and project management skills are essential requirements of the role.

Position Responsibilities:

· Manage packaging, labelling, storage, and distribution vendors.

· In coordination with Clinical Operations, Clinical Supply Chain, and Technical Operations, develop clinical packaging strategies, timelines, and budgets for existing and upcoming clinical trials.

· Plan and coordinate Vendor activities for creating label and packaging design(s), scheduling packaging campaigns and production of labels, and coordinating return drug management activities.

· Facilitate the design, review, and approval of IP label text and label proofs to meet the packaging requirement and compliance with specific country regulations.

· Collaborate with Clinical Supply Chain to monitor inventory levels at sites and depots closely through the life of a trial, taking preventative actions to avoid any supply issues.

· Generate and maintain an accurate account of IP inventory on hand including tracking IP consumption, material movements, lot information, and expiry.

· Working closely with QA, ensure timely review and approval of batch records for packaging and labeling of IP.

· Collaborate with IRT vendor, distribution vendor, and the clinical study team to develop IRT specifications and perform User testing

· Manage and follow up on reported Temperature Excursions and/or Product Complaints from sites/depots.

· Coordinate the expiration date extension and re-labeling operations. Ensure expiry extensions are provided to depot/sites to support continued use.

· Coordinate the shipping validation shipments and other activity. 

Candidate Requirements:

· Bachelor’s degree or higher in health or life sciences, preferred.

· Minimum 5 to 10 years of direct experience in clinical supply management from trial start-up to close-out, including planning & forecasting, labeling, packaging, QP release, storage, distribution, reconciliation, returns, and destruction.

· Experience managing third-party clinical supply vendors required.

· Experience managing QP releases.

· Experienced in managing clinical study needs and possesses the skills and ability to support early and late phase Programs.

· Demonstrated Knowledge of GMP batch record development, review, approval, and release processes.

· Demonstrated knowledge of warehousing, distribution, and logistics (including cold chain distribution).

· Strong Microsoft skills, including Excel, power point, etc. 

The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.

Planet Pharma and The Planet Group of Companies are equal opportunity employers. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.

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About Cambridge, MA

Calling all job seekers! Discover exciting job opportunities in and around Cambridge, Massachusetts, a vibrant city known for its rich history, world-renowned universities like Harvard and MIT, and innovative tech scene. Cambridge offers a unique blend of academic excellence, cultural diversity, and a thriving arts community, with attractions like the iconic Harvard Square, the charming Charles River Esplanade, and the prestigious American Repertory Theater. From savoring local specialties like clam chowder and lobster rolls to cheering on the Red Sox at Fenway Park, there's something for everyone in this dynamic region. Explore job listings today and kick-start your career in this captivating area!

Although this hasn't been an issue at Planet Pharma, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.