Associate Director, Drug Product Manufacturing

Overview: 

This position will provide technical leadership for drug product technology transfers and manufacturing, including CMO oversight to ensure successful clinical and commercial cGMP production. Scope entails development and implementation of fill/finish processes for novel immuno-oncology products.

Responsibilities: (including but not limited to the following):

• Drug Product Process Development
  • Lead technology transfers for drug product manufacturing
  • Oversee efforts at CMOs to ensure vial aseptic fill technology transfer activities are executed per process development procedures and best practices
  • Provide technical leadership to 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
  • Mentor/coach junior staff and support their professional development
• 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
  • Represent Coherus as person-in-plant during production runs
• Quality and Compliance
  • Ensure corporate standards are met in both quality and compliance with cGMP standards
  • Ensure compliance with international (ICH, EMA), and S. (CFR, FDA, OSHA) regulations and ensure adherence to all company policies and procedures relating to Good Manufacturing Practices, EH&S practices, etc.
  • Author, review, and approve SOPs required for drug product process development activities

Qualifications:

• Minimum BS required, degree in chemical engineering or similar field
• Minimum of 10 years’ drug product experience in the biopharmaceutical industry
• Must have strong knowledge of biologics manufacturing and aseptic processing expertise
• Demonstrated track record of successful drug product process development
• Must have knowledge of applicable Quality and Regulatory guidelines
• Prior experience managing third party CMO relationships and as person-in-plant during manufacturing runs
• Must have strong interpersonal skills and the ability to communicate effectively with external partners, peers, and senior management
• Must work well in cross-functional teams and effectively mentor junior team members
• Ability to travel domestically and internationally, up to 25%
• Must have strong computer skills, including MS Office applications
• Experience with statistical methodologies and software such as JMP or Minitab desirable

The Base Salary Range for this position is $170,000 to $200,000. Coherus considers various factors, including professional background and work experience, when determining base pay. These considerations mean actual compensation will vary.

Coherus provides equal employment opportunities to all employees and applicants for employment and prohibits unlawful discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. We also prohibit discrimination based on the perception that anyone has any of these characteristics or is associated with a person who has or is perceived as having any of these characteristics.