Director, CMC Project Management (Biologics)

About Our Client

Our client is stealth stage biopharmaceutical company dedicated to developing next-generation antibody biotherapeutics. They are currently seeking a highly skilled and strategic Biologics CMC Project Manager to spearhead their chemistry, manufacturing, and controls (CMC) operations from Post-Candidate Selection (PCC) through IND submission.

This is a fantastic opportunity to join a lean, high-performing team where your leadership will directly impact the acceleration of life-changing therapies to clinical trials.

Responsibilities

• Develop comprehensive project plans, timelines, and budgets for biologics CMC development projects from PCC nomination to IND submission.
• Participate in screening, selection, and qualification of Contract Development and Manufacturing Organizations (CDMOs) for various biotherapeutic modalities including mAb, BsAb, TsAb, fusion protein, protein conjugates etc.
• Support due diligence efforts associated with CMC development activities, support service contract negotiations and other CDMO related activities.
• Drive multidisciplinary CMC teams, including cell line development, upstream and downstream process development, formulation development, analytical method development and qualification, drug substance and drug product manufacturing, quality control, regulatory filing, and supply chain management to maximize the value of development work and ensure effective communications and quality decisions.
• Keep all the stakeholders fully apprised of project status and issues at the right level of detail. Understand escalate issues to teams and stakeholders appropriately.
• Identify technical gaps in development and manufacturing and implement proactive remediations and strategies to ensure project success.
• Ensure adherence to regulatory requirements for both development and manufacturing activities.

Requirements

• BS/BA and above degree in biochemistry, biochemical engineering or other life science disciplines.
• Minimum of 10+ years of biologic therapeutic development / commercialization experience with BS/BA degree or minimum of 6+ years biologic therapeutic development experience with an advanced degree.
• Demonstrated deep understanding and experience in biologic modality drug development and manufacturing processes for mAb, BsAb, TsAb, fusion protein, protein conjugates etc.