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Director, Biologics

New York City, NY, USA | Beacon Hill Pharma

  • Industry:
    HR / Recruitment Services
  • Position Type:
  • Functions:
    General Management
  • Experience:
    10-12 years
Job Description:
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The Director of CMC Biologics is accountable for all aspects of biologics development including pre-clinical and clinical antibody manufacturing. The candidate will work closely with Research to support technology transfer to manufacturing settings.


The primary responsibility of this position is technical oversight for GMP cell banking, cell culture, antibody purification, fill/finish, and bioanalytical and quality control to support all stages of development.


The position will be based in NY, MA, or PA.


Provide scientific and technical expertise in the design, qualification, and validation of manufacturing operations to meet global standards of quality and regulatory compliance.

Technical lead of the development of the antibody therapeutic products from R&D small scale to GMP manufacturing

Maintain effective working relationships with CMO partners as senior development expert for managing production of clinical drug substance / drug product

Work collaboratively with Research, Quality Assurance, Regulatory, CMC Supply Operations, Clinical Operations, and Project Management

Develop goals, plans and performance metrics

Identify risk and risk mitigation strategies

Oversee development of robust, compliant manufacturing process

Approve technical reports and CMC sections for regulatory submissions

Prepare data reports for internal communications. Effectively communicate results to internal collaborators and to senior management




BS/MS/PhD in life science (biochemistry, pharmaceutical sciences, etc) with at least 10 years of experience in biotechnology

Proactive leadership and management skills to maintain and develop on-going biologics programs

Ability to manage all interactions with CMOs, including definition of project scope, RFP submission, quote review and selection, and technical oversight

Experience in GMP develop-ability, manufacturing and scale- up of antibodies containing products

Ability to work with clinical operations to deliver drug product supporting clinical studies

Proven experience with regulatory submissions (IND, BLA, …)

Ability to travel internationally

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