Director, Analytical Sciences, Drug Product
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 clarify 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 laboratory achievement and innovation to join our Pharmaceutical Sciences group at ORIC Pharmaceuticals. The candidate will provide analytical leadership on projects, working closely with cross-functional teams to bring new therapeutics to cancer patients. The successful candidate will report to the VP, Head of Pharmaceutical Sciences and will be responsible for:
- Leading all drug product (DP) analytical activities in-house and at external vendors, including method development, validation, product release, stability testing, investigations, deviations, control strategy, and impurities characterization.
- Mentoring and developing team members, fostering scientific innovation, independence, and an inclusive culture of growth. Building and maintaining state-of-the-art analytical lab capabilities.
- Building strong relationships with external vendors, supporting reviews, visits, and audits.
- Developing phase-appropriate analytical and product strategies, providing technical guidance, and ensuring regulatory compliance for all analytical aspects.
- Representing DP Analytical Sciences in cross-functional teams and contributing to leadership deliverables including budgeting, project management, and strategic planning.
Qualifications
Requirements
- Ph.D. in analytical chemistry or a relevant field with 12+ years of industry experience, preferably including late-stage drug development and NDA filings.
- Excellent communication skills for preparing presentations and conveying ideas clearly.
- Ability to work independently and collaboratively in a fast-paced, multidisciplinary environment.
- Hands-on experience in GLP and cGMP environments with analytical technologies such as UHPLC, GC, LC-MS, and others.
- Experience in regulatory document writing, product specifications, and validation reports.
- Understanding of ICH and regulatory guidances.
- Strong problem-solving skills, scientific curiosity, and adaptability.
- Ability to take initiative and provide strategic input.
Additional Information
The salary range is estimated between $210K-$260K, dependent on experience and qualifications.
ORIC is an equal opportunity employer, committed to diversity and inclusion.
#J-18808-Ljbffr