Director of CMC Biologics

JOB FUNCTION: Scientific
JOB TYPE: Direct Hire
LOCATION: Waltham, MA
COMPENSATION: $160k - $220k
REMOTE / ONSITE: Onsite
POSTED: Sep 16, 2022

Our client is a biotechnology company working on therapies for muscular disease. They are currently seeking a Director of CMC Biologics to join their team.

Salary/Hourly Rate:

$160k – $220k

Position Overview:

The Director of CMC Biologics will be responsible for building the internal CMC ability and process and manage external specialists. The Director of CMC Biologics will work in the biologics process and analytical development, drug substance and drug product from pre-IND through late-phase clinical studies. This role is responsible for the delivery of robust, scalable, and cost-effective manufacturing.

Responsibilities of the Director of CMC Biologics:

  • Provide leadership and oversight/execution of operational targets
  • Manage external contract development and manufacturing organizations
  • Oversee process and assay technology transfers and the process through supply to clinical sites
  • Drive continuous improvement opportunities
  • Evaluate emerging technologies/applications to improve our products and processes
  • Serve as the liaison to define suitable, compliant, and defendable CMC strategies
  • Prepare technical documentation, publications, and oral presentations
  • Prepare and review relevant CMC and product-related sections and documentation for global regulatory submission
  • Review and approve documents related to cGMP operations
  • Oversee the implementation of process improvements at CDMOs

Qualifications of the Director of CMC Biologics:

  • 7 – 10 years of experience
  • Direct experience working with upstream and downstream biologics processes
  • Antibody experience is preferred
  • Solid experience in a CMC/cGMP environment
  • Commercial launch experience is preferred
  • Knowledge of tech transfers in the biotech or pharmaceutical industry
  • Strong facilitation skills and the ability to influence and negotiate positive outcomes

Education Requirements:

  • Advanced degree in Biochemistry, Chemical Engineering, Pharmaceutical Sciences, or equivalent with a focus on complex biologics

Benefits:

  • Client-provided benefits
As a woman-owned firm, we value diversity. We are an equal opportunity employer and will consider all applications without regard to race, sex (including gender, pregnancy, sexual orientation and gender identity), age, color, religion or creed, national origin or ancestry, veteran status, disability (physical or mental), genetic information, citizenship or any other characteristic protected by law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.
Position ID: 114030