Director Analytical Sciences - 22-136
Fully Remote
Description


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.   He/She 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.


Responsibilities: 


• Provides scientific and technical leadership in respect of Analytical Development for projects at various stages of the drug development life cycle

• Leads or contributes to the strategy, planning, execution, and progress reporting for development projects 

• Manages activities which include analytical method assessment, development, transfer, validation and troubleshooting for drug substances and drug products, reference standard management, and stability program oversight

• Provides detailed review and approves protocols, reports, and raw data for analytical method qualification/validation, release testing, and reference materials qualification

• Works closely with external CRO/CDMOs collaborators to c advance method development, qualification, transfer, and validation for API and DP for advanced programs

• Identifies, evaluates, selects, and develops relationships and actively manages 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

• Ensures processes are in line with health, safety, environmental and quality requirements including regulations, policies, applicable guidelines, and procedures



Requirements


• Master’s degree in analytical chemistry or related field with at least 10+ years, or a Ph.D 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 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