Job Details

Client is seeking a highly motivated analytical research and development scientist with a proven record of sustained laboratory achievement and innovation to join their growing CMC group. The candidate will be part of cross-functional teams providing analytical leadership on projects, working closely on a shared mission to bring new therapeutics to cancer patients.

Job Description

The successful candidate will report to the Sr. Director of Analytical Sciences and will be responsible for:

• Management of outsourced and in-house research activities. Function as a subject matter expert for tech transfer/development of processes to external vendors (contract development and manufacturing organizations/contract testing organizations, CDMOs/CTOs). Create and execute plans for external projects by providing technical guidance, strategic and tactical direction, and oversight to ensure the product requirements are designed and delivered appropriately and in a timely manner for all stakeholders and customers across all stages of drug development, from discovery through preclinical to clinical and commercial.
• Independently lead and oversee analytical method development, validation, solid state characterization, release, and stability testing activities at CDMOs and in-house.
• Manage GMP manufacturing and product characterization activities at external partners, including preparation and review of analytical methods, Method Validation Protocols, Method Validation Reports, Stability protocols, and CoAs; work closely with process and formulation colleagues to propose/ justify specifications for RSMs, IPCs, intermediates, API, and DP based upon batch history data and control strategy.
• Manage and provide technical guidance during investigations/ quality events at CDMOs/ CTOs in collaboration with quality.
• Author and review technical reports, technical data packages, and relevant sections in health authority filings (including INDs, NDAs, annual reports, and any other regulatory interactions), and contribute to regulatory filing strategy.
• Prepare presentation materials and clearly communicate research results to manager, and at internal/external meetings.
• Work cross-functionally with Regulatory, Quality, Pre-clinical, Clinical supply, Process and Formulations Development colleagues.
• Maintain oversight of batch genealogy, stability, and test results to ensure all information is appropriately archived, readily available, and is transformed into useful knowledge and understanding.
• Work closely with formulation and process colleagues for CDMO selection, enablement and troubleshooting at site, and tech transfer. Proactively coordinate and work with CTOs, CDMOs, and CMOs ensuring smooth tech transfer, uninterrupted clinical supplies.
• Communication excellence in managing projects and deliverables, including budget planning, oversight in partnership with cross-functional colleagues, periodic organization and documentation of progress and accruals, and contract/PO/invoice coordination with finance.

• Ph.D. in analytical chemistry or relevant field with 10+ years of relevant hands-on pharmaceutical/biotech industry experience, or equivalent, in the field of new drug discovery and development.
• Demonstrated problem-solving skills, scientific curiosity, passion, critical thinking, and ability to quickly adapt and shift focus as needed.
• Demonstrated ability to take initiative, ownership, problem identification, problem solving and strategic input. A proven record of sustained laboratory achievement and innovation.
• Extensive hands-on experience and mechanistic understanding of analytical technologies including UHPLC, GC, LC-MS, GC-MS, SFC, dissolution, disintegration, wet chemistry, DSC, TGA, PSD, XRPD, spectroscopic and compendial methods.
• Awareness and knowledge of cross-functional activities such as toxicology and clinical development.
• Demonstrated ability to work independently and efficiently in a collaborative, fast-paced, integrated, multidisciplinary team environment that includes work internally and with external partners, such as research organizations/Universities, CTOs, CMOs, and CDMOs.
• Experience in writing and reviewing product specifications, method validation protocol/ reports, analytical methods, development reports, risk assessments, release, and stability.
• Experience in late-stage pharmaceutical drug development, such as discriminating dissolution method development, building control strategy, assembling data and authoring an NDA for a small molecule commercial product is highly preferred.
• Experience in process chemistry aspects of new drug development, including fate and purge studies, specification setting and justification, and other aspects required to building control strategy, assembling data and authoring an NDA for a small molecule commercial product is highly preferred.
• Working understanding of all ICH and regulatory guidances. A strong attention to detail and demonstrated prior experience working in lab, GLP, and cGMP environment.
• Scientific excellence as demonstrated by publications, presentations, and leadership/engagement in the scientific/professional community.
• Onsite, hybrid, or remote work are all negotiable.