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Senior Manager/Associate Director, Clinical Drug Product Manufacturing

Company: Coherus BioSciences
Location: Redwood City
Posted on: October 18, 2020

Job Description:

We're looking for a candidate to fill this position in an exciting company.

  • The Senior Manager/Associate Director of Clinical Drug Product Manufacturing will be responsible for all activities associated to the execution of clinical drug product manufacturing.
  • Leads the design, development and technology transfer for new and existing drug product manufacturing processes, as well as develop processes to monitor and manage the day to day manufacturing to ensure supply.
  • This position will provide technical expertise in the areas of aseptic fill/finish, drug product technology transfer, primary packaging, visual inspection and drug product process analytics
  • Responsible for ensuring CMO drug product (fill finish) manufacturing facilities meet drug product requirements as per business plan.
  • Work with CMOs to deliver on all clinical drug product supply requirements through process ownership, trouble shooting, transfer and analysis of robust manufacturing processes.
  • Tracks the placement of replenishment orders with suppliers and monitors delivery and release schedules.
  • Responsible for coordination with CMO for the storage and shipment of inventory. Accountable for meeting quality, delivery, inventory and cost objectives.
  • Responsible for working with the CMO to ensure drug product (lyophilized, as well as vial and syringe) batch fill finish activities are executed aseptically and as per process development procedure.
  • Responsible for working with the CMO to ensure lyophilized product formulation and cycle development are employed as appropriate
  • Ensures critical corporate standards are met both in the quality and compliance areas, with strict GMP standards, equally throughout the distribution network.
  • Ensure compliance with federal (FDA, DEA, EPA, OSHA, EMA and other global regulatory authorities), state and local regulations and adherence to all company policies and procedures relating to Good Manufacturing Practices, EH&S practices, etc.
  • Responsible for the maintenance of the GMP material control system.
  • Oversees policies, procedures and systems related to the planning and control of raw materials, work-in progress and finished product.
  • Provides leadership with the CRO in the development of raw material policies, procedures and risk mitigation strategies.
  • Provides leadership in implementing and expanding the use of business systems such as MRP/ERP
  • BS or equivalent experience is required. APICS CPIM, CIRM certifications are desirable, but not required.
  • Minimum of 10 years of experience in a supply chain discipline in the pharmaceutical / biopharmaceutical or other high-tech industries.
  • Demonstrated ability to work effectively with a strong team of professionals.
  • Experience in GMP raw material management, Quality and Regulatory guidelines.--
  • Must work well in cross-functional teams and be able to communicate effectively with external partners, peers, and senior management. This includes prior experience managing third party CMO relationships.
  • Must have strong negotiating and interpersonal skills, and the ability to clearly present recommendations.
  • Excellent decision making, leadership, interpersonal, written and verbal communication skills.
  • Must have experience with MRP/ERP systems and their implementation. Must have strong computer skills, including all MS Office applications.
  • Ability to travel domestically and internationally, up to 25% and for short term assignments (3 months) up to 50%.

Keywords: Coherus BioSciences, Redwood City , Senior Manager/Associate Director, Clinical Drug Product Manufacturing, Executive , Redwood City, California

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