Senior Director, Drug Product Manufacturing

Location San Francisco
Discipline: Regulatory Affairs
Job type: Permanent
Salary: £Salary: On application
Contact name: Sam Murphy

Contact email: sam.murphy@rbwconsulting.com
Contact phone: 16179821238
Job ref: 21461
Published: about 1 month ago
Expiry date: 11 June 2021

Drug Product Process Development

  • Lead technology transfers for drug product/combination product manufacturing

  • Work 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

  • Author CMC sections of regulatory submissions

  • Act as technical point of contact during regulatory agency interactions

Formulation and Fill/Finish Manufacturing

  • Serve as technical site lead for CMOs and provide subject matter expertise for drug product manufacturing unit operations

  • Partner with CMOs to ensure successful clinical and commercial cGMP production

  • Provide technical support to manage deviations, corrective actions, change controls, process monitoring, and process improvements Quality and Compliance

  • Ensure corporate standards are met in both quality and compliance with cGMP standards

  • Ensure compliance with international (ICH, EMA), and U.S. (CFR, FDA, OSHA) regulations and ensure adherence to all company policies and procedures relating to Good Manufacturing Practices, EH&S practices, etc.

  • Represent Coherus as person-in-plant during production runs

  • Coordinate and attend meetings with drug product CMOs

  • Travel as required to domestic and international manufacturing sites

Experience, Education, Training, Traits:

  • Minimum BS required, degree in chemical engineering or similar field

  • Minimum of 8 years drug product experience in the biopharmaceutical industry

  • Must have strong knowledge of biologics manufacturing and aseptic processing expertise

  • Must have experience with drug product process development

  • Must have knowledge of applicable Quality and Regulatory guidelines including combination product and device development design controls

  • Prior experience managing third party CMO relationships and as person-in-plant during manufacturing runs

  • Must have strong decision-making, leadership, interpersonal skills and the ability to communicate effectively with external partners, peers, and senior management

  • Must work well in cross-functional teams

  • Ability to travel domestically and internationally, up to 25%

  • Must have strong computer skills, including MS Office applications

  • Experience with statistical software such as JMP or Minitab desirable

Salary: On application