Manager/Senior Manager, Drug Product Manufacturing

Location
Redwood City, California
Posted
Jul 02, 2022
Ref
3987475
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
Title:                                    Manager/Senior Manager, Drug Product Manufacturing Reports To:                         Associate Director, Drug Product Manufacturing Location:                             Redwood City, CA
Classification:                    Exempt 

Overview:

This Manager or Senior Manager will provide technical support for biologic drug product technology transfers and manufacturing, including CMO oversight to ensure successful clinical and commercial production.  Scope entails development and implementation of fill/finish processes for biosimilars, as well as exciting novel immuno-oncology products.

Principal Responsibilities and Duties (including but not limited to the following):

  • Drug Product Process Development
    • Support technology transfers for drug product/combination product manufacturing
    • Interface with CMOs to ensure syringe and vial aseptic fill technology transfer activities are executed per process development procedures and best practices
    • Identify, design, execute, evaluate, and document studies characterizing drug product processes based on solid scientific and engineering principles
    • Support preparation of CMC sections of regulatory submissions
  • Formulation and Fill/Finish Manufacturing
    • Provide subject matter expertise for drug product manufacturing unit operations
    • Provide technical support to manage deviations, corrective/preventive actions, change controls, continued process verification, and process improvements
    • Provide Person-In-Plant oversight of development and manufacturing activities at CMO sites
  • Quality and Compliance
    • Ensure corporate standards are met relating to quality and compliance, Environmental Health & Safety (EH&S), etc.
    • Ensure compliance with international (ICH, EMA), and U.S. (CFR, FDA, USP, OSHA) regulations and license requirements including current Good Manufacturing Practices (cGMP)
    • Author and review SOPs required for drug product process development activities

 

Experience, Education, Training, Traits: 

  • BS degree required at minimum, in chemical engineering or similar field
  • Minimum of 5 years drug product experience in the biopharmaceutical industry
  • Strong knowledge of biologics manufacturing and aseptic processing expertise, including knowledge of vial and syringe processing
  • Experience with drug product process development
  • Prior experience managing third-party CMO relationships and serving as Person-In-Plant during manufacturing runs
  • Strong interpersonal skills and the ability to communicate and collaborate effectively with external partners and peers
  • Must work well in cross-functional teams
  • Ability to travel domestically and internationally, up to 25%
  • Strong computer skills, including MS Office applications
  • Experience with statistical software such as JMP desirable

​Beginning July 19, 2021, Coherus BioSciences requires all new hires to be fully vaccinated against COVID-19 as of their start date.  This requirement is a condition of employment at Coherus BioSciences, and it applies regardless of whether the position is located at a Coherus BioSciences facility or is fully remote.  If you are unable to receive the vaccine due to a disability or serious medical condition, or because it is prohibited as a result of your sincerely held religious beliefs, you will have an opportunity to request a reasonable accommodation.