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Manager/Sr. Manager Clinical Supply Chain

Watertown, MA

Posted: 09/19/2018 Job Category: Clinical: Supplies/ Logistics Job Number: 2115

Client is seeking a talented and highly motivated Manager/Sr. manager Clinical Supply Chain with significant expertise in supply chain management to join their CMC group in Watertown, MA. Responsible for day-to-day activities related to managing the supply of Investigational Product (IP) through all stages of clinical development including packaging, labeling and distribution as well as, supporting and advising Clinical Operations, and clinical sites on all aspects of IP and comparator products as applicable. This position reports to the Director of CMC.

Responsibilities:
  • Support all clinical supply activities for on-going and new clinical trials for on-time delivery, including demand forecasting, trial monitoring & resupply planning, IRT set-up and distribution activities
  • Design and execute packaging and labelling campaign
  • Support the procurement, labeling and distribution of comparators
  • Manage Contract Development and Manufacturing Organizations (CDMO) and provide comprehensive information about clinical supplies
  • Ensure continuous supply of clinical trial material for all ongoing studies within the US and ex-US locations
  • Ensure on time startup of new studies by having supplies available as required
  • Manage clinical packaging and distribution contractors
  • Review clinical protocols and design appropriate supply chain strategy
  • Design specifications for automated randomization and drug supply management systems
  • Oversee a variety of logistics issues, including but not limited to supply chain services, inventory control, import-export, shipment of products and third-party warehousing
  • Act as primary liaison for inventory control and distribution activities including scheduling, issue resolution, change implementation, vendor oversight and scope review related to clinical supplies
  • Establish measures and metrics to define manufacturing and supply chain performance and provide recommendations to Management to optimize operations both internally and externally
  • Work closely with Procurement and IP groups to establish supplier relationships and service agreements with cost effective distribution of Clinical Trial Material
  • Work collaboratively and transparently with Clinical Operations, Quality Assurance and Regulatory Affairs


Minimum Education/Skills Required:
  • BS degree with 7+ years’ experience in a Supply Chain Planning role in a Biotechnology or Pharmaceutical environment. MBA degree in a Supply Chain Management is a plus
  • Experience managing contract packaging and labeling organizations (strongly preferred)
  • Experience with developing risk-based supply strategy for an early to late stage clinical development programs
  • Thorough understanding of regulatory requirements for clinical supply distribution in US, APAC, and EU including testing and labeling requirements
  • Thorough understanding of cGMP, GCP, GDP and national/international transportation requirements for pharmaceutical materials
  • Experience working with QP, IVRS, IWRS, depots with global IP distribution
  • Excellent project management and communication skills
  • Must thrive in a fast-paced innovative environment while remaining flexible, proactive, resourceful and efficient

Demeika Roberts

Demeika is known for her enthusiasm in working closely with hiring managers to assess their needs, creatively solve problems, and passionately help candidates find their “perfect fit” dream jobs.

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