Senior Manager, Analytical Sciences

• Management of outsourced and in-house research activities. Function as a subject matter expert for tech transfer/development of processes to external vendors (contract development and manufacturing organizations/contract testing organizations CDMOs/CTOs). 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 stakeholders and customers across all stages of drug development from clinical to commercial.
• Independently lead and oversee analytical method development validation solid state characterization release/ stability testing data review and trending retest/shelf-life extensions and NDA enabling activities at CDMOs and in-house.
• Manage 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 colleagues to propose/ justify specifications for RSMs IPCs intermediates and API based upon batch history data and analytical control strategy.
• Manage and provide technical guidance during investigations/ quality events at CDMO and CROs in collaboration with quality.
• Author and review development/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 cross-functionally with Regulatory Quality Clinical supply and Process chemistry 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.
• Communication excellence in managing projects and deliverables including budget planning oversight in partnership with cross-functional 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 7-10 years of relevant hands-on pharmaceutical/biotech industry experience or equivalent in the field of new drug discovery and development.
• 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. A proven record of sustained laboratory achievement and innovation.
• Experience in process chemistry aspects of new drug development including fate and purge studies specification setting and justification and other aspects required to build a control strategy assembling data and authoring an NDA for a small molecule commercial product is a must.
• Extensive hands-on experience and mechanistic understanding of analytical technologies including UHPLC GC LC-MS GC-MS SFC dissolution disintegration wet chemistry DSC TGA PSD XRPD spectroscopic and compendial methods.
• Proven track record of Person-in-Plant (PIP) oversight and a history of working within a late-stage commercial company are highly preferred.
• Awareness and knowledge of cross-functional activities such as toxicology and clinical development.
• Demonstrated ability to work independently and efficiently in a collaborative fast-paced integrated multidisciplinary team environment that includes work internally and with external partners such as research organizations/Universities and CDMOs.
• Experience in writing and reviewing product specifications method validation protocol/ reports analytical methods development reports risk assessments release and stability.
• Working understanding of all ICH and regulatory guidance. 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.
•  hybrid or remote work is negotiable.

Additional Information :

The anticipated base salary for candidates who will work on-site at our San Diego location is between $170000-$185000 per year. The final rate offered to a successful candidate will be dependent on several factors that may include title type and length of experience within the role type and length of experience within the industry education geography and other job-related factors. This position is not eligible for H-1B visa sponsorship.

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 characteristics.

Remote Work :

No

Employment Type :

Full-time