Director, CMC Drug Substance - 22-161
Fully Remote
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. He/She 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.


Responsibilities:

  • Directs 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
  • Leads or contributes to the strategy, planning, execution, and progress reporting for development projects as well commercial products 
  • Identifies, evaluates, selects, and develops relationships and actively manages external partners (CROs, CMOs, RM suppliers, consultants, etc.). This includes writing, reviewing, and managing requests for proposals, statements of work, contracts, budgets, and timelines
  • Ensures processes are in line with health, safety, environmental and quality requirements including regulations, policies, applicable guidelines, and practices
  • Develops and provides high level guidance to senior management on CMC requirements and generates project and resource plans for company drug substance development
  • Preparation of necessary CMC documents suitable for regulatory filings as needed
  • Efficiently supports cross functional project teams. Coordinates drug substance activities with analytical and drug product development teams within CMC. Understands and supports the needs and requirements from other functional groups including toxicology, pharmacokinetics, and regulatory. Provides updates to project and management teams
Requirements
  • 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
  • Author appropriate Quality sections for regulatory submissions (IND, IMPD, and/or NDA) 
  • Experienced 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
  • Excellent ability to work both independently and in a matrix team environment, in a goal and team-oriented setting and handle competing priorities
  • Strong ethical standards, with the ability to speak up, identifying critical risks and gaps while providing appropriate mitigations/solutions
  • Provide a positive approach to Elevar’s workspace, while fostering an inclusive and collaborative environment


Elevar’s policy is to provide equal employment opportunities to all applicants and employees without regards to race, color, religion, creed, gender identity or expression, age, national origin or ancestry, citizenship, disability, sexual orientation, marital status, pregnancy, veteran status, membership in the uniformed services, genetic information, or any other basis protected by applicable law.