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Associate Director/Director, Drug Substance Development and Manufacturing
2 months ago
We are seeking an Associate Director or Director, Drug Substance development and manufacturing in the CMC team. The Chemistry, Manufacturing and Controls (CMC) team is highly collaborative team that operates at our New York Headquarters. The associate director or director of Drug Substance will be expected to utilize and manage a global network of Contract Research Organizations (CROs) and Contract Manufacturing Organizations (CMOs) to develop processes and manufacture drug substance for pre-clinical through commercial stage projects. The Associate Director or Director of Drug Substance CMC is expected to be seen as an expert in synthetic routes of chemistry and process chemistry both within our company and when working with CROs/CMOs. This position will be based in New York.
Key Responsibilities:
- Develop and optimize synthetic route and processes for small molecule drug substances supporting all stages of development from IND enabling studies to clinical studies to validation and commercialization.
- Manage developmental stage-appropriate analytical activities for monitoring material quality.
- Collaborate with cross-functional teams, including analytical development, formulation development, quality assurance, and regulatory affairs, to ensure seamless project progression
- Devise and execute detailed plans for tech transfer, process familiarization and manufacturing utilizing external CROs/CMOs to ensure timely delivery of GMP drug substance and drug product.
- Participate in budget planning and API needs forecasting (including expenditures with CROs/CMOs and consultants).
- Prepare technical reports and presentations to communicate results and progress to internal and external stakeholders including leadership team
- Own the drug substance modules in the regulatory dossier and collaborate with regulatory affairs to support regulatory submissions and inspections.
- Able to anticipate, identify, and resolve key scale-up challenges through critical evaluation of process and analytical data.
- Mentor direct reports and team members (internal as well as external) assuring desired project outcomes.
- Incorporate QbD principles and novel technology to process development, as appropriate.
Requirements:
- Advanced degree (PhD/Masters) in chemistry, chemical engineering, or a related discipline is required with a minimum of 10 years of experience in the pharmaceutical or other related industry. Exceptional candidates without an advanced degree may be considered.
- Hands-on working experience and in-depth understanding of GMP requirements and CMC regulatory requirements for small molecule drug substance manufacturing and related quality requirements.
- Technical project leadership experience in early-stage and/or late-stage drug substance process development.
- Familiar with medicinal chemistry and working knowledge of organic chemistry
- Working knowledge of drug substance analytical methods including phase-appropriate qualification/validation requirements.
- Strong skills applying fundamental engineering and scientific principles to process design, implementation, and tech transfer
- Experience managing and building strong relationships with contract manufacturing organizations
- Experience with successful drug submissions (IND, BLA, IMPD, MAA, etc.) as well as phase-appropriate cGMP requirements
- First-hand experience in writing/assisting with CMC documents for regulatory submissions.
- Excellent interpersonal and communication skills (written and oral). This includes the ability to effectively and accurately present data to peers, management, and external partners
Preferred:
- Experience with process development and characterization using QbD principals and application of risk assessment tools such as FMEA.
- Prior experience in technical management of domestic and international CROs/CMOs.
- Experience in a small company or start-up environment
