Senior Manager/Associate Director, Clinical Drug Product Manufacturing
Company: Coherus BioSciences
Location: Redwood City
Posted on: October 18, 2020
We're looking for a candidate to fill this position in an
- 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
- Responsible for ensuring CMO drug product (fill finish)
manufacturing facilities meet drug product requirements as per
- 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
- Responsible for working with the CMO to ensure lyophilized
product formulation and cycle development are employed as
- 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
- Oversees policies, procedures and systems related to the
planning and control of raw materials, work-in progress and
- 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
- Demonstrated ability to work effectively with a strong team of
- Experience in GMP raw material management, Quality and
- 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
- 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
- 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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