Senior Director, Analytical Sciences, Drug Product

Company Description

ORIC is a research-driven company dedicated to discovering and developing novel therapies that can Overcome Resistance In Cancer. Our collaborative, empowering culture gives scientists the authority, responsibility, and support to do cutting-edge work on therapies for treatment-resistant cancers. Our culture and values support our mission, provide a shared understanding of how we work together as a company and provide a clear sense of what is most important for us as an organization.

Job Description

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 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 VP, Head of Pharmaceutical Sciences and will be responsible for the following.

• Lead all drug product (DP) analytical activities in-house 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 shelf-life/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 state-of-the-art analytical lab capabilities to support discovery, pre-formulation 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 cross-functional 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 12-15+ years of relevant hands-on pharmaceutical/biotech industry experience, or equivalent, in the field of drug discovery and development. Experience in late-stage 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, fast-paced, integrated, multidisciplinary team environment that includes work internally and with external partners, such as research organizations/Universities, CROs, CMOs, and CDMOs.
• Extensive hands-on experience in GLP and cGMP environment, and thorough understanding of analytical technologies including UHPLC, GC, LC-MS, GC-MS, SFC, dissolution, disintegration, wet chemistry, DSC, TGA, PSD, XRPD, spectroscopic and compendial methods, and solid-state 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 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.
  
  

Additional Information

The anticipated salary range for candidates is between $240K-$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.