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JO-4268

Quality Search - Since 1981

Position Title

Manager, Global Supply Operations, Cold Chain

Primary Work Location

Greater Boston area

Experience

5 or more years

Specialty

Cold Chain, Pharmaceuticals

Salary

Mid Point of $115K

Bonus

10-15%

Education

B.S. Degree in Engineering or related Scientific discipline

Travel

10-% Domestic and International

Direct Reports

No

Relocation

Yes

Other

Candidates MUST have experience with Cold Chain Pharmaceuticals. 

DESCRIPTION - DUTIES

Company Overview:  This company is a U.S. commercial-stage biopharmaceutical company focused on the discovery and development of unique RNA-targeted therapeutics for the treatment of rare neuromuscular diseases. The Company is primarily focused on rapidly advancing the development of its potentially disease-modifying muscular dystrophy (DMD) drug candidates.


Position:  The Manager, Global Supply Operations, Cold Chain position will focus mainly on developing cold chain solutions to execute against company Clients cold chain strategy. This involves developing and qualifying cold chain shipping solutions for both active and passive systems for refrigerated, frozen, and ultra-low temperatures. He, or she, will work closely with Global Supply Chain, QA/QC, Technical Development, Regulatory Affairs and CMC teams to implement new processes and manage changes.


Primary Responsibilities Include:

·        Develop, specify, and qualify cold chain shipping solutions for active and passive shipping systems

·        Work closely with CMOs and logistics providers to implement robust operations including detailed pack-out and handling instructions

·        Partner with internal teams to select third party logistics providers, and be the SME for controlled temperature

·        storage and logistics

·        Works with Analytical teams to develop a deep understanding of temperature excursion requirements for all products

·        Develop SOPs and Policy’s related to the management of controlled temperature storage, shipping, qualification, and

·        the handling of temperature excursions

·        Developing temperature monitoring programs for raw materials, intermediates, clinical, and commercial products across the entire supply chain. This includes specifying temperature data loggers and managing temperature data.

·        Authoring of technical protocols, reports, and regulatory submissions

·        Developing a deep understanding of current and future external supply needs and ability to clearly link supplier utilization to overall strategy

·        Be the person in-plant during validation activities and routine production as necessary

·        Develop rigorous strategies to reduce costs and supply risk through disciplined analysis, analytics, trending and modeling of key operational data

·        Developing tools, processes, and criteria to evaluate supplier performance

REQUIREMENTS - BACKGROUND

Education:  Requires a B.S. Degree in Engineering, Packaging or related Scientific discipline


Experience:  Requires 5 or more years of experience in the pharmaceutical, chemical, or related industry, with at least 3 years in a position directly related to pharmaceutical cold chain.  This role requires experience with developing cold chain systems and packaging development Experience with ISTA /ASTM standards and qualifying cold chain shipping containers.


Candidates must be authorized to work in the U.S.

Contact us to discuss this opportunity - OR -  Pass this job along to a fellow Packaging Professional

Quality Search, 1820 Graham Drive • Chesterton, IN 46304-1627 • (219) 926-5015 www.qsjobs.com

We promise never to share your information with anyone without your prior consent.

 

For further details on JO-4268

Inquire through Tony Vesh

Ph:  (219) 926-6831     Bio of Tony Vesh

Inquire through Peter Nye

Ph:  (219) 851-7478     Bio of Peter Nye

Inquire through Doug Scripture

Ph:  (269) 598-1915     Bio of Doug Scripture

Inquire through Jeff Wolfe

Ph:  (219) 926-5015     Bio of Jeff Wolfe

- OR -

 

Inquire through Quality Search

A Recruiter will be assigned to you.

Ph:  (219) 926-7772     Web Site   

We look forward to working with and for you in your career enhancement!

 

 



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