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Associate Director, Supply Chain

Company: Unum Therapeutics
Location: Cambridge
Posted on: September 16, 2020

Job Description:

200 Cambridgepark Dr, Cambridge, MA 02140, USA

Full-time

Company Description Unum Therapeutics is currently going through a major transformation, read more about it here:

This is the time to join if you enjoy the energy and fast-paced environment from small/startup biotech all while working with stellar colleagues.

Job Description The Senior Manager/Associate Director Clinical Supply Chain Management position will be responsible for managing multiple investigational drug supplies for world-wide trials. She/he will oversee all aspects of clinical supply management including forecasting, packaging, labeling, distribution, monitoring inventory, and vendor oversight. She/he will have an excellent understanding of the drug development process and be able to independently forecast and manage supply needs and distribution.

What You’ll Do

Develop strategic clinical supply packaging and labeling designs to fulfill clinical study dosing requirements, patient compliance, and effective study execution by sites. Collaborate with CMC/Manufacturing, Clinical Operations, QA, Regulatory Affairs, vendors, and others, as required, to finalize and implement designs.

Develop and manage forecasts by creating and reviewing clinical supply demand for the clinical trial projections.

Assess labeling, packaging and distribution needs on a study-by-study basis and identify appropriate vendors to conduct this work. Establish agreements with these vendors.

Manage direct outsourcing of labeling, packaging, storage, and distribution of manufactured drug supply and co-administered and/or comparator supplies, as required, to global sites.

Create and manage timelines and budgets to ensure on-time, on-budget delivery of product to sites, raising risks proactively.

Coordinate shipments of in-process GMP materials and released clinical materials between vendors and storage sites, Support country logistics for shipping and importation for the development programs.

Works closely with CMC Manufacturing to ensure that production schedule is sufficient to meet all supply chain requirements

Manage vendors and their respective contracts, invoice review, and budget planning. Establish practices and SOPs as needed, to support industry best practices. Collaborate with Quality to establish and regularly review Quality Agreements with vendors and partners providing packaging, labeling and/or distribution services.

Qualifications What You Bring

BS, MS or PharmD degree, Pharmacy degree preferred, and at least 6-8 years of clinical supply chain experience within pharma/biotech. APICS certification or coursework is desired.

Thorough understanding of GXPs governing the manufacture of pharmaceutical drug products and conduct of routine clinical trials distribution.

Extensive experience in clinical supply management including forecasting, logistics (labeling, packaging, distribution, expiries), inventory tracking, and managing IRT systems.

Must be knowledgeable in US, EU, and ROW clinical supply labeling requirements and the QP review/release/certification process for European clinical supplies.

Experience with both ambient and cold chain products.

Must be able to effectively manage multiple activities and problem-solve to achieve business needs.

Strong communication skills, able to work independently and collaborate with key internal and external stakeholders.

Additional Information Where are we?

Unum is located within walking distance of the Alewife T station in Cambridge, MA. Our space includes an open office layout designed for collaboration and state-of-the-art laboratories. Free access is provided for both on-site parking and gym facilities in the building. We are in close proximity to leading academic institutions like MIT and Harvard and to potential pharmaceutical and biotech partners. This unique location allows for a high level of energy and intellectual exchange within and among fast growing early stage companies.

What do we offer you?

To attract the very best talent, we offer a generous benefits package that includes competitive pay, performance-based bonus, stock options, insurance coverage (health, dental, life, and disability), unlimited time-off, a 401(k) plan, and commuter/parking benefits.

Unum is an equal opportunity employer

Note to agencies – we are not accepting unsolicited resumes from agencies and will not be responsible for fees associated with any such submittals

200 Cambridgepark Dr, Cambridge, MA 02140, USA

Keywords: Unum Therapeutics, Cambridge , Associate Director, Supply Chain, Other , Cambridge, Massachusetts

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