What are the responsibilities and job description for the Associate Director Analytical Sciences position at ORIC Pharmaceuticals?
ORIC Pharmaceuticals Inc is a clinical stage oncology company dedicated to improving patients lives and focused on developing treatments that address mechanisms of therapeutic resistance. 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 CMC 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 Sr. Director of Analytical Sciences and will be responsible for :
- Management of outsourced and inhouse research activities. Function as a subject matter expert for tech transfer / development of processes to external vendors and CMOs. Create and execute plans for external projects by providing technical guidance strategic and tactical direction and oversight to ensure the product requirements are designed and delivered appropriately and in a timely manner for all the stakeholders and customers across all the stages of drug development from discovery through preclinical to clinical and commercial.
- Independently lead and provide oversight for analytical method development solid state characterization validation release and stability testing activities at CDMOs and inhouse.
- Management of GMP manufacturing and product characterization activities at external partners including preparation and review of analytical methods Method Validation Protocols Method Validation Reports Stability protocols and CoAs; work closely with process and formulation colleagues to propose specifications for RSMs IPCs intermediates API and DP based upon batch history data and control strategy.
- Manage and provide technical guidance during investigations / quality events 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 contribute to regulatory filing strategy.
- Prepare presentation materials and clearly communicate research results to manager and at internal / external meetings.
- Work crossfunctionally with Regulatory Quality Preclinical Process and Formulations Development colleagues.
- Maintain oversight of batch genealogy stability and test results to ensure all information is appropriately archived readily available and is transformed into useful knowledge and understanding.
- Work closely with formulation and process colleagues for CMO selection enablement and troubleshooting at site and tech transfer. Proactively coordinate and work with CROs CDMOs and CMOs ensuring smooth tech transfer uninterrupted clinical supplies.
- Communication excellence in managing projects and deliverables including budget planning oversight in partnership with crossfunctional colleagues periodic organization and documentation of progress and accruals and contract / PO / invoice coordination with finance.
Qualifications :
Additional Information :
All your information will be kept confidential according to EEO guidelines.
Remote Work : Employment Type :
Fulltime
Key Skills
Program assessment,FDA Regulations,Manufacturing & Controls,Program Evaluation,budget forecast,Research Experience,Operations Management,Research & Development,Strategic Planning,Contract Management,Leadership Experience,negotiation
Experience : years
Vacancy : 1
