AD/Director, CMC - Drug Substance Development

New York, NY

About the job


Company Background:

Gilgamesh Pharmaceuticals is a clinical stage biopharmaceutical company aspiring to deliver innovative therapeutics to address the unprecedented unmet need for improved mental health treatments. Research to date for NMDA receptor antagonist and 5HT2A receptor agonist prototype molecules has revealed exciting efficacy outcomes and shows promise to be a true leap forward in allowing people to achieve more enjoyable, fulfilled lives. Key therapeutic indications under investigation include MDD, Bipolar Disorder, Substance Use Disorder and OCD. All Gilgamesh programs are entirely new proprietary chemical entities.


Job Description:

We are seeking a dynamic and experienced professional to join our team as the Director/Associate Director of CMC, Drug Substance Development. The successful candidate will play a pivotal role in driving the development and manufacturing of small molecule drug substances to support our diverse portfolio of pharmaceutical products. The successful candidate will be responsible for providing committed and accountable leadership to Gilgamesh management by delivering well-developed CMC solutions critical to advancing the company’s development pipeline.


This position requires broad-based expertise to help create and implement stage-appropriate solutions for the manufacture of drug substance. Specific responsibilities include procurement, vendor management, synthesis design, process development, specification setting, and manufacture of non-clinical and clinical grade drug substances and related compounds. The position will work closely with the Head of CMC, Project Management, Clinical Operations, Regulatory, and multiple key stakeholders in internal and external governance committees.


Responsibilities:

  • Leadership and Strategy:
  • Provide strategic leadership for drug substance development that aligns with the overall corporate goals and objectives.
  • Provide oversight and direction on drug substance development activities including late-stage discovery support, raw and starting material sourcing, process development and transfer, clinical stage manufacturing, validation, and quality management.
  • Technical Expertise:
  • Utilize knowledge of pharmaceutical development to design manufacturing processes that are safe, scalable, robust, cost effective, and environmentally friendly.
  • Apply fundamental chemistry and engineering principles to address complex challenges involving syntheses; reaction analytics and kinetics; salt, polymorph and particle size attributes; impurity profile management; physical-chemical stability; bioavailability; process safety; and equipment selection.
  • Apply quality-by-design principles in a phase-appropriate manner to ensure process robustness in the manufacture of toxicological, clinical, registration stability, and process validation batches.
  • Identify opportunities for intellectual property creation/enhancement and work to efficiently prosecute them when appropriate.
  • Analyze and summarize complex data sets. Prepare technical reports, publications and oral presentations.
  • Regulatory Compliance:
  • Implement best practices in process development, technology transfer, and manufacturing to ensure process development, specifications, manufacture, and validation meet or exceed industry and regulatory requirements.
  • Oversee the preparation and submission of regulatory documents related to drug substance CMC, ensuring compliance with global regulatory requirements.
  • Utilize knowledge of controlled substance regulations globally in strategic planning and the selection and management of outsourcing partners.
  • Collaborate with regulatory affairs to address queries and facilitate regulatory inspections.
  • Project Management:
  • Develop and manage work plans that include process development strategies that translate into deliverables and milestones in a constantly evolving work environment.
  • Develop contingency plans where necessary.
  • Manage all aspects of the company’s outsourcing activities including selection of outsourcing partners, contract management, budget planning, technical collaboration/supervision and the progression of milestones and deliverables.
  • Travel domestically and/or internationally to accomplish objectives, when necessary.
  • Cross-Functional Collaboration:
  • Provide project teams with integrated technical, timeline, and budgetary packages to achieve pre-clinical, clinical development and regulatory objectives.
  • Communicate risks and delays to line management/project teams in a timely fashion.
  • Partner with Discovery Chemistry on syntheses to facilitate candidate nomination into development. Work closely with external partners, CROs, and CDMOs to facilitate process development, technology transfer and manufacturing activities.
  • Work with Discovery Chemistry, outsourcing partners, and patent counsel to appropriately expand the Gilgamesh intellectual property portfolio.
  • Travel domestically and/or internationally to accomplish objectives, when necessary, including participation in periodic (~semi-annual) in-person meetings of Gilgamesh employees.
  • Continuous Improvement:
  • Drive continuous improvement initiatives to enhance the efficiency and robustness of drug substance manufacturing and overall CMC processes.
  • Implement novel technologies and methodologies to stay at the forefront of industry trends.


Requirements:

  • PhD in Chemistry, Chemical Engineering, or a related discipline with a minimum of 10 years of experience in pharmaceutical drug substance development and manufacturing.
  • Proven track record of successful leadership in a pharmaceutical CMC role, with a focus on drug substance development involving route selection, methodology development, process development, process safety, material characterization, quality-by-design principles, intellectual property protection, negotiating and managing contracts.
  • Strong laboratory skills and knowledge of organic synthesis and pharmaceutical development. Excellence in the use and interpretation of modern analytical techniques.
  • Strong understanding of global regulatory requirements and experience interacting with regulatory agencies on matters pertaining to GMP manufacturing, risk management and quality control strategies, and drug safety.
  • Excellent communication and interpersonal skills.
  • Ability to effectively collaborate with cross-functional teams and external partners.
  • Demonstrated ability to lead and mentor a high-performing team.
  • History of self-starting, multi-tasking, and flexible work style in a fluid environment.
  • Experience in preparing IND (or IMPD) and/or NDA/MAA submissions.
  • Working knowledge of drug product development and clinical supply chain management is a strong plus.
  • Working knowledge of and experience with controlled substance regulation is a strong plus.


If you are a highly motivated individual with a passion for improving the lives of patients with neuroscience and mental health disorders, we encourage you to apply for this exciting opportunity. We offer a competitive salary, equity, benefits package, and opportunities for professional growth and development.


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