Head of CMC
Our client is a biotechnology company. They have asked us to assist them in a search for a Head of CMC.
Major tasks and responsibilities include:
We seek candidates with the following qualifications:
- Directs CMC activities for the Pre-Investigational New Drug Application throughout early and late stage clinical development.
- Manages and oversees Contract Development and Manufacturing Organizations (CDMOs) for process development, GMP manufacture, and supply of drug product (DP) in support of clinical programs.
- Coordinates and monitors progress to ensure quality and timelines.
- Guides external operations including technology transfer, process and method development, optimization, qualification and validation of all activities related to CMC operations.
- Reviews CDMO documents, including technical reports, master and executed batch records, protocols, change controls, and documents related to supply chain and logistics in support of clinical studies.
- Prepares CMC regulatory filings.
- Participates in regulatory strategy developments, regulatory filings, and meetings with regulatory agencies.
- Maintains an up-to-date understanding of all applicable regulations and industry standards for the development of biological products.
- Requires a PhD or MS in engineering, biochemistry, or a relevant discipline.
- Must have 15+ years of experience in the biotech/pharmaceutical industry, and experience in all stages of biologics CMC development.
- Requires expertise in CMC functional areas.
- Must have a solid understanding of cGMP and FDA regulations and guidelines related to CMC, and experience in the preparation of CMC regulatory filings.
- Required to be proficient in the process of analyzing scientific data and results with the ability to review scientific documents.
- Must have strong problem solving and risk-based decision-making skills, and a strong ability to influence or manage without having direct authority.
- Requires highly developed interpersonal and communication skills.
If interested, please apply directly to this job posting. No calls please. Include your daytime phone number and we will contact you confidentially or reply to your email.
Fairway Consulting Group is included in Hunt Scanlon’s list of Top 50 Healthcare & Life Sciences Search Firms.