Head of Chemistry, Manufacturing and Controls, Gilgamesh

Remote

Role

This position will report to the Chief Executive Officer and will be responsible for all Chemistry, Manufacturing and Controls activities for Development Projects. The primary goals for the VP of CMC over the next 24 months will be enabling the Phase I clinical studies for two Gilgamesh programs, one oral and one iv, by providing clinical supplies that meet all required cGMP and ICH guidelines.

Specifically:

  • Oversee all manufacturing activities from candidate identification through clinical phases
  • Develop robust, scalable, and cost-effective manufacturing processes for drug substance (API) and drug product (DP)
  • Develop and implement stage appropriate analytical methods and protocols (independent generation, academic collaboration or external vendor management) to ensure product quality
  • Execute plans to ensure that the manufacturing and QC processes are in accordance with cGMP, ICH (International Council on Harmonization), and FDA/EMA regulations
  • Design and develop process optimization to support clinical manufacturing, scale up, technology transfer, validation and regulatory filings
  • Identify, select and manage Contract Development and Manufacturing Organizations (CDMOs) for process optimization, cGMP manufacturing, and supply of drug substance and drug product in support of ongoing non-clinical and clinical activities
  • Oversee technology transfer including manufacturing process and analytical methods from Gilgamesh to CDMOs/CROs and vice versa
  • Ensure that all CDMOs/CROs are using systems and processes in compliance with all relevant regulatory standards
  • Review/prepare cGMP batch records, analytical methods, method validation reports, CMC regulatory and quality documents
  • Forecast drug substance and drug product needs and manage supply chain and logistics in support of preclinical and clinical programs
  • Prepare budget estimates and control costs for CMC activities
  • Evaluate small molecule candidates for further development including library design, lead optimization, solid state characteristics and scalability consistent with a target candidate profile to complement Gilgamesh’s portfolio of medicinal drugs
  • Liaise with internal and external groups to ensure timelines and IND-enabling activities are on track

Qualifications

  • 15 or more years of experience in a pharmaceutical or biotechnology CMC/cGMP environment
  • Successful track record in designing and selecting small molecules for pharmaceutical development and oversight of activities leading to regulatory filings
  • Experience in managing CROs/CDMOs for the manufacture of cGMP API and DP
  • Experience with SC/IV and Inhalable formulation/devices preferred
  • Experience with IND and NDA filings and thorough knowledge of relevant FDA and EMA regulations
  • Strong project management skills across functional teams with a track record of proactive problem solving
  • Strategic leadership and tactical skills, excellent initiative and judgment, and demonstrated ability to positively represent the goals of Gilgamesh
  • Experience in an early stage, privately held biotechnology company is desirable
  • Demonstrated ability to develop and maintain excellent working relationships with both internal colleagues and external contacts, including key thought leaders, and investigators
  • Demonstrated ability to work well in teams in a cross functional manner
  • Demonstrated ability to communicate and work independently with scientific/technical personnel
  • Ability to think critically, and demonstrated troubleshooting and problem solving skills
  • Self-motivated and willing to accept temporary responsibilities outside of initial job description
  • Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities

Education

  • Advanced degree (MS or PhD) in Chemistry, Chemical Engineering or a related discipline

Compensation

  • An attractive compensation package commensurate with this senior leadership role will be provided
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