Director, Analytical Sciences (Remote) - 25-100

The Director, Analytical Sciences serves as the responsible leader with oversight of analytical chemistry 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 selection and implementation of appropriate analytical methods. 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: 

• Provide scientific and technical leadership in respect of Analytical Development for projects at various stages of the drug development life cycle
• Lead and contribute to the strategy, planning, execution, and progress reporting for development projects 
• Manage activities which include analytical method assessment, development, transfer, validation and troubleshooting for drug substances and drug products, reference standard management, and stability program oversight
• Provide detailed review and approve protocols, reports, and raw data for analytical method qualification/validation, release testing, and reference materials qualification
• Work closely with external CRO/CDMOs collaborators to advance product development through late-stage clinical studies to commercialization
• Author and update CMC documents suitable for regulatory filings (IND’s, IMPD’s, NDA’s, MAA’s, etc.)
• Identify, evaluate, select, and develop relationships and actively manage external parties (CROs, CMOs, RM suppliers, consultants, etc.). This includes writing, reviewing, and managing requests for proposals, statements of work, contracts, budgets and timelines, and oversight on due diligence efforts.
• Ensure processes are in line with health, safety, environmental, and quality requirements including regulations, policies, applicable guidelines, and procedures

• 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.
• Master’s degree in analytical chemistry or related field with at least 10+ years, or a PhD with a minimum of 8+ years of experience, with increasing responsibility
• Extensive technical experience in analytical testing, method development and phase-appropriate qualification/validation, characterization, and support of stability programs for small molecule drug substance and their corresponding drug product
• A broad understanding of cGLP/cGMP requirements, compendia testing, ICH, FDA, and EMA guidelines with respect to pharmaceutical product development and manufacture
• Excellent interpersonal and communication skills (written and oral), including the ability to effectively and accurately present data to peers, management, and external partners
• Direct experience in the authoring of analytical and stability sections of NDA, MAA, IND and IMPD
• 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
• 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 $190,000 to $220,000. 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.

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