Senior Scientist, Analytical Sciences

• Independently lead analytical development and product characterization activities for our 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. Expected to 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.

Qualifications

• 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.

Additional Information

The anticipated salary range for candidates who will work on-site at our South San Francisco location is between $150,000-$180,000. The final wage offered to a successful candidate will be dependent on several factors that may include, title, type and length of experience within the role, type and length of experience within the industry, education, geography, and other job-related factors.

ORIC Pharmaceuticals, Inc. is an equal opportunity employer. ORIC does not discriminate based on race, color, religion, gender, sexual orientation, gender identity, age, national origin, disability status, protected veteran status, or any other legally protected characteristics.