Senior Scientist, Analytical Sciences

ORIC Pharmaceuticals•South San Francisco, CA

19h•$150,000 - $180,000•Onsite

About The Position

ORIC Pharmaceuticals is seeking a lab-based, highly motivated Senior Scientist in Analytical Sciences. 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. The successful candidate will report to the Sr. Director of Analytical Sciences. This role involves independently leading analytical development and product characterization activities for drug development portfolios, providing oversight and technical guidance for analytical method development, transfer, validation, release, and stability testing at CDMOs. The scientist will also function as a subject matter expert for physical/chemical characterization of NCEs at CROs, conceptualize and conduct experiments, interpret and present data, and solve challenging problems using various analytical techniques. Maintaining accurate lab records and adhering to safety and regulatory guidelines are essential. The role includes creating and executing strategic plans, providing technical guidance during investigations, and authoring/reviewing technical reports and regulatory filings. Communication and project management skills are crucial, including budget planning and contract coordination.

Requirements

Ph.D. in analytical chemistry or related field with 3+ years of experience, or equivalent, in the field of drug discovery and development.
Demonstrated problem-solving skills, critical thinking, and ability to quickly adapt and shift focus as needed.
Demonstrated ability to take initiative, ownership, and provide strategic input.
A proven record of sustained laboratory achievement and innovation.
Extensive hands-on experience in analytical technologies including UHPLC, GC, LC-MS, GC-MS, SFC, dissolution, disintegration, wet chemistry, DSC, TGA, PSD, XRPD, spectroscopic and compendial methods.
Thorough mechanistic understanding of underlying science and contemporary practice of various analytical technologies and development for new drug candidates in preclinical through early and late-stage clinical development.
Awareness and knowledge of cross-functional activities such as DMPK, 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 CROs and CDMOs.
Experience in writing and reviewing product specifications, method validation protocols/ reports, analytical methods and development reports.
Working understanding of ICH and regulatory guidance.
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 communities.

Responsibilities

Independently lead analytical development and product characterization activities for drug development portfolios.
Provide oversight, technical guidance and tactical direction for analytical method development, transfer, validation, release, and stability testing activities at CDMOs.
Function as a subject matter expert for in-depth physical/ chemical characterization of NCEs at CROs.
Independently conceptualize, design, and conduct experiments; interpret and present data and conclusions to various audience, including senior leadership.
Solve challenging problems by application of one or more (traditional or emerging) analytical techniques.
Maintain timely and accurate lab records consistent with good documentation practices and work in compliance with all applicable laboratory, safety, quality, and regulatory guidance and requirements.
Create and execute strategic plans for projects, both internally and externally, ensuring product requirements are designed and delivered appropriately and in a timely manner for all the stakeholders and customers at all stages of drug development - from discovery through preclinical to clinical and commercial.
Provide technical guidance during investigations at CDMOs/ CROs 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 support any due diligence/partnership efforts.
Communication excellence in project management; budget planning, oversight of progress and periodic accruals, and contract/PO/invoice coordination with finance; follow-ups and keeping activities on track meeting high quality deliverables in a timely manner.