Associate Director Analytical Sciences
Associate Director Analytical Sciences
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Salary Not Disclosed
1 Vacancy
Job Description
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 :
- Ph.D. in analytical chemistry or relevant field with 10 years of relevant handson pharmaceutical/biotech industry experience or equivalent in the field of new drug discovery and development.
- 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. A proven record of sustained laboratory achievement and innovation.
- Extensive handson experience and mechanistic understanding of analytical technologies including UHPLC GC LCMS GCMS SFC dissolution disintegration wet chemistry DSC TGA PSD XRPD spectroscopic and compendial methods.
- Awareness and knowledge of crossfunctional activities such as toxicology and clinical development.
- Demonstrated ability to work independently and efficiently 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.
- Experience in writing and reviewing product specifications method validation protocol/ reports analytical methods development reports release and stability.
- Experience in latestage pharmaceutical drug development such as discriminating dissolution method development building control strategy assembling data and authoring an NDA for a small molecule commercial product is highly preferred.
- Experience in process chemistry aspects of new drug development including fate and purge studies specification setting and justification and other aspects required to building control strategy assembling data and authoring an NDA for a small molecule commercial product is highly preferred.
- Working understanding of all ICH and regulatory guidances. 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 community.
- Onsite hybrid or remote work are all negotiable.
Additional Information :
All your information will be kept confidential according to EEO guidelines.
Remote Work :
No
Employment Type :
Fulltime
Employment Type
Full-time
