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Manager, contract manufacturing – top 10 global pharma – remote

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This is a Full-time position in Bridgewater, NJ posted November 27, 2019.

We’ve just been engaged by a multi-billion dollar specialty pharmaceutical & medical device company to assist with their search for an experienced, hands-on Manager of Contract Manufacturing.

This role will sit remotely and support the manufacturing of complex medical devices, working directly with their Northeast CMO partners.

This role will also support continuous improvement activities in the manufacture and release of medical device products.

The manager is responsible for all activities across the product development life cycle, but most specifically from design transfer forward through obsolescence.

ROLE OVERVIEW:
• Work with CMO to execute the production plan to deliver an uninterrupted supply of clinical & commercial product.
• Support investigations at CMO’s and 2nd/3rd Tier suppliers (RCI’s, CA’s, etc)
• Lead and/or participate in technology transfers, new product launches, validation activities, CIP’s, etc with the CMO and internal cross functional teams including Device Engineering, Regulatory Affairs and Quality departments.
• Work with internal and external teams to coordinate changes to materials, processes and equipment.
• Coordinate activities in the evaluation of process, equipment and material changes, to ensure efficient implementation without impacting supply.
• Act as the focus and conduit for communications between the CMO and with members of manufacturing group and other departments to meet the supply plan.
• Support medical device production through continuous improvements and daily production support
• Process Change Orders, CAPA’s, Purchase Orders, Invoices as required
• Key member of the External Supply Operations Team contributing to performance tracking metrics
• Act as the Operations representative on the Product Support Team and use the project tracking system as required.
• Contribute to contracts and negotiations with CMO
• Act as back up to the Director of contract manufacturing as needed
• Internally this person will interact with Quality Assurance, Quality Control, Verification/Validation, Device Engineering, Supply Chain, Finance, Compliance, Legal, and Regulatory.

This role will also be the main contact for all CMO manufacturing related communications.

EDUCATION:
• Bachelor’s degree or higher in Science or Engineering is a requisite.
• Qualifications/Certifications in any of the following is desirable: Lean Manufacturing/Six Sigma, Supply Chain, Project Management.QUALIFICATIONS:
• Experience in outsourced medical device manufacturing, manufacturing technologies and process development.
• 5+ years Medical device experience is required with a strong production management and/or supplier relationship management experience.
• Knowledge of extracorporeal blood processing systems (collection, apheresis, dialysis, cardiac assist, etc.) is desirable.
• Experience developing, delivering, deploying and maintaining medical devices under FDA Quality Systems Regulations, CE Marking, and ISO Quality Systems is preferred.
• Possesses a working knowledge of regulatory agency requirements
• Advanced level mastery of both business/technical applications.
• Six Sigma and/or Lean Certification and expertise is desired
• Experience driving continuous improvement in manufacturing is desired.
• The ability to prioritize tasks to meet deadlines
• Ability to start up and lead cross functional teams in the resolution of short-term issues or sustained performance for long term goals.
• Demonstrated ability to project manage technology transfer and/or new product launches.
• Use of Lean Six Sigma tools in continuous improvement projects.
• Familiarity with an ERP system and Trackwise documentation systems are desirable
• Excellent organizational, written and verbal communication & negotiation skills desired.
• Experience with injection mold tool design, implementation and maintenance is preferred
• Experience with Ultrasonic/RF Welding, Solvent bonding, Medical device assembly is desiredWORK ENVIRONMENT / PHYSICAL DEMANDS:
• Travel: 20% 60%, Ability to travel by air, car, etc.
• Travel will be required to visit CMOs, supplier sites and company locations which include Upstate NY, Vermont, New Jersey, North Carolina, Wisconsin and Europe
• This is a field-based position that will require a home office setup.