Description

The Director, CMC Drug Substance serves as the responsible leader with oversight of CMC Drug Substance in support of progressing Elevar’s development pipeline and ensuring sustained product supply. This position will provide strategic guidance on short- and long-term planning as well as technical insight in the implementation, optimization and establishing robustness of the manufacture of drug substance. The role will involve significant collaboration within the CMC group as well as cross-functionally with regulatory, quality, and external partners. This is a remote-based position located in the United States.

Responsibilities:

• Direct the CMC drug substance development and manufacturing activities within Elevar’s portfolio by providing scientific and technical leadership including oversight of multiple projects at various stages of the drug development life cycle from late-phase clinical studies, through filing/launch and sustained supply
• Lead and contribute to the strategy, planning, execution, and progress reporting for development projects as well as commercial products
• Identify, evaluate, select, and develop relationships and actively manage external partners (CROs, CMOs, RM suppliers, consultants, etc.). This includes writing, reviewing, and managing requests for proposals, statements of work, contracts, budgets, and timelines.
• Ensure processes are in line with health, safety, environmental, and quality requirements including regulations, policies, applicable guidelines, and practices
• Develop and provide high-level guidance to senior management on CMC requirements and generate project and resource plans for company drug substance development
• Author and update CMC documents suitable for regulatory filings (IND’s, IMPD’s, NDA’s, MAA’s, etc.)
• Efficiently support cross-functional project teams
• Coordinate drug substance activities with analytical and drug product development teams within CMC
• Understand and support the needs and requirements from other functional groups including toxicology, pharmacokinetics, and regulatory
• Provide updates to project and management teams
  
  

Requirements

• Bachelor’s degree with 15 years; Master’s degree with 12 years; or PhD with 8 year’s experience. Proven director-level/functional area management experience demonstrating business acumen, developing and delivering functional/department strategy, delivering results, championing innovation, coaching and developing subordinates including remote and cross-functional teams.
• Ph.D. in organic chemistry (preferred) or chemical engineer with at least 7 or more years of related technical experience in the pharmaceutical/biotech industry
• In-depth knowledge and experience in synthetic route development, process optimization, large-scale manufacturing of drug substance, and technical transfer to external partners
• Prior experience selecting and working with domestic and international CMOs and consultants including awareness of best industry practice and emergence of enabling technology
• Familiarity with analytical techniques and methods used to characterize small molecule APIs
• A broad understanding of cGLP/cGMP requirements, compendia testing, ICH, FDA, and EMA guidelines with respect to pharmaceutical product development and manufacture
• Direct experience in authoring of drug substance sections of NDA, MAA, IND, and IMPD
• Experience in developing a robust control strategy including defining process risks, identifying critical process parameters (CPP), and establishing proven acceptable ranges (PAR)
• Excellent interpersonal and communication skills (written and oral), including the ability to effectively and accurately present data to peers, management, and external partners
• Strong ethical standards, with the ability to speak up, identifying critical risks and gaps while providing appropriate mitigations/solutions
• Ability to demonstrate Elevar’s core values by holding ourselves and each other accountable for the work we do, taking time to collaborate effectively while working remotely, making space for ingenuity in work and thought, and staying grounded in compassion
  
  

The anticipated annual base salary range for this role is $200,000 to $230,000. Final compensation depends on multiple factors including but not limited to, relevant experience, skillset, depth and breadth of knowledge, internal equity, and external market factors. Elevar Therapeutics is a rapidly growing biotech company that offers competitive wages and benefits package including medical, dental, vision, time off, a retirement plan, and other voluntary benefits for employees.