Associate Director, Process Chemistry

• Management of outsourced and in-house research and development activities. Lead drug substance activities on one or more projects.  Function as a subject matter expert for 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.
• Management of GMP manufacturing activities at external partners including preparation and review of MBRs and EBRs work closely with Analytical Sciences to support method development and validation and manage quality event resolution for GMP compliance.
• Lead scientific and technical thinking on assigned projects. Effectively working cross-functionally with Regulatory Quality Analytical and Formulations Development colleagues to deliver on program objectives and deliverables. 
• Author and review technical reports technical packages 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 closely with clinical and preclinical colleagues for need forecasting and supply logistics including CMO selection enablement and troubleshooting at site and tech transfer. Proactively coordinate and work with CROs CDMOs and CMOs ensuring uninterrupted clinical supplies. Communication excellence in project management; budget planning oversight in partnership with quality regulatory clinical and preclinical departments. Periodic documentation of progress and accruals and contract/PO/invoice coordination with finance. 

Qualifications :

• PhD in organic chemistry with 10years of relevant hands-on pharmaceutical/biotech industry experience or equivalent in the field of new drug discovery and development
• Proven track record for solving process chemistry problems including identification optimization and characterization of robust and scalable synthetic routes.
• Scientific excellence as demonstrated by publications presentations and leadership/engagement in the scientific/professional community.
• Working understanding of analytical tools used in process development (DSC TGA DVS HPLC NMR KF PLM XRPD).
• Understanding of reaction safety hazards assessment and its application to reaction scale-up.
• Detailed understanding of process characterization in preparation for validation including experience with using statistical methods for reaction modeling to support filings.
• Experience in tech transfer scale-up manufacturing on multikilogram scale and working in GMP environment.
• 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 CROs CMOs and CDMOs.
• Experience in writing and reviewing batch records specifications stability protocols/data review and development reports.
• Experience in late-stage pharmaceutical and process chemistry drug development including putting together data and documents towards authoring/reviewing and submitting an NDA for a small molecule commercial product highly preferred.
• Demonstrated ability to quickly adapt and find creative solutions to ensure deliverables are met as external environment and stakeholder input evolves.

Excellent oral and written communication skills. Succinct but thorough communication skills with attention to detail analytical/critical thinking and data organization presentation and inference.

Additional Information :

The anticipated salary range for candidates is between $175000-$200000 in South San Francisco.  The final rate 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.  

Remote Work :

No

Employment Type :

Full-time