New York, NY, USA | Beacon Hill Pharma
Industry:HR / Recruitment Services
Job Description:53 people have viewed this job
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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