Director, Analytical Sciences, Drug Product

We are seeking a highly motivated analytical research and development scientist with a proven record of sustained laboratory achievement and innovation to join our growing Pharmaceutical Sciences group at ORIC Pharmaceuticals. The candidate will be part of crossfunctional 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 VP Head of Pharmaceutical Sciences and will be responsible for the following.

• Lead all drug product (DP) analytical activities inhouse and at external vendors (CDMOs and CROs) including method development optimization/troubleshooting validation; product release and stability testing; OOS/OOT investigations deviations and other quality events; control strategy and specification setting; impurities characterization; and shelflife/retest date assignment.
• Mentor and develop team members by fostering scientific innovation independence and an inclusive culture of learning growth and continuous improvement. Build and maintain internal stateoftheart analytical lab capabilities to support discovery preformulation and formulation development.
• Build strong working relationships with external vendors and support annual reviews technical visits and quality audits.
• Develop phase appropriate analytical and product strategies and execute plans by providing technical guidance strategic and tactical direction and oversight to ensure uninterrupted clinical supply and registration readiness. Accountable for all aspects of analytical DP regulatory filings and quality compliance internally and at CDMOs.
• Represent DP Analytical Sciences in crossfunctional teams. Contribute to all PharmSci Leadership Team (PSLT) deliverables including budgeting project management and strategic planning. Ensure the Analytical Sciences strategy and results are effectively communicated at the Pharmaceutical Development team meetings and other internal and external (e.g. CDMO) forums.

Qualifications :

Requirements

• Ph.D. in analytical chemistry or relevant field with 12 years of relevant handson pharmaceutical/biotech industry experience or equivalent in the field of drug discovery and development. Experience in latestage drug development including NDA preparation/filing commercialization and commercial technical operations for small molecule drugs is highly preferred.
• Excellence in verbal and written communication including preparation of presentation materials and concisely and clearly conveying ideas strategy and data as needed in all interactions.
• Demonstrated ability to work independently and effectively in a collaborative fastpaced integrated multidisciplinary team environment that includes work internally and with external partners such as research organizations/Universities CROs CMOs and CDMOs.
• Extensive handson experience in GLP and cGMP environment and thorough understanding of analytical technologies including UHPLC GC LCMS GCMS SFC dissolution disintegration wet chemistry DSC TGA PSD XRPD spectroscopic and compendial methods and solidstate and physical testing.
• Experience in writing and reviewing regulatory documents product specifications method validation protocol/ reports analytical methods development reports and stability reports.
• Working understanding of all applicable ICH and regulatory guidances.
• Demonstrated problemsolving 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.

Additional Information :

The anticipated salary range for candidates is between $210K$260K The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the title type and length of experience within the job type and length of experience within the industry education etc. 

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 characteristic.  

Remote Work :

No

Employment Type :

Fulltime