Senior Scientist, Analytical Sciences

South San Francisco, CA - USA

Monthly Salary: Not Disclosed

Posted on: 13 hours ago

Vacancies: 1 Vacancy

Job Summary

Independently lead analytical development and product characterization activities for our drug development portfolios. Provide oversight technical guidance and tactical direction for analytical method development transfer validation release and stability testing activities at CDMOs. Function as a subject matter expert for in-depth physical/ chemical characterization of NCEs at CROs.
Independently conceptualize design and conduct experiments; interpret and present data and conclusions to various audience including senior leadership. Expected to solve challenging problems by application of one or more (traditional or emerging) analytical techniques. Maintain timely and accurate lab records consistent with good documentation practices and work in compliance with all applicable laboratory safety quality and regulatory guidance and requirements.
Create and execute strategic plans for projects both internally and externally ensuring product requirements are designed and delivered appropriately and in a timely manner for all the stakeholders and customers at all stages of drug development - from discovery through preclinical to clinical and commercial. Provide technical guidance during investigations 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 support any due diligence/partnership efforts.
Communication excellence in project management; budget planning oversight of progress and periodic accruals and contract/PO/invoice coordination with finance; follow-ups and keeping activities on track meeting high quality deliverables in a timely manner.

Qualifications :

Ph.D. in analytical chemistry or related field with 3 years of experience or equivalent in the field of drug discovery and development.
Demonstrated problem-solving skills critical thinking and ability to quickly adapt and shift focus as needed.
Demonstrated ability to take initiative ownership and provide strategic input. A proven record of sustained laboratory achievement and innovation.
Extensive hands-on experience in analytical technologies including UHPLC GC LC-MS GC-MS SFC dissolution disintegration wet chemistry DSC TGA PSD XRPD spectroscopic and compendial methods. Thorough mechanistic understanding of underlying science and contemporary practice of various analytical technologies and development for new drug candidates in preclinical through early and late-stage clinical development.
Awareness and knowledge of cross-functional activities such as DMPK 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 CROs and CDMOs.
Experience in writing and reviewing product specifications method validation protocols/ reports analytical methods and development reports.
Working understanding of 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 communities.

Additional Information :

The anticipated salary range for candidates who will work on-site at our South San Francisco location is between $150000-$180000. The final wage 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.

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 :

Employment Type :

Full-time

Independently lead analytical development and product characterization activities for our drug development portfolios. Provide oversight technical guidance and tactical direction for analytical method development transfer validation release and stability testing activities at CDMOs. Function as a su...

Independently lead analytical development and product characterization activities for our drug development portfolios. Provide oversight technical guidance and tactical direction for analytical method development transfer validation release and stability testing activities at CDMOs. Function as a subject matter expert for in-depth physical/ chemical characterization of NCEs at CROs.
Independently conceptualize design and conduct experiments; interpret and present data and conclusions to various audience including senior leadership. Expected to solve challenging problems by application of one or more (traditional or emerging) analytical techniques. Maintain timely and accurate lab records consistent with good documentation practices and work in compliance with all applicable laboratory safety quality and regulatory guidance and requirements.
Create and execute strategic plans for projects both internally and externally ensuring product requirements are designed and delivered appropriately and in a timely manner for all the stakeholders and customers at all stages of drug development - from discovery through preclinical to clinical and commercial. Provide technical guidance during investigations 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 support any due diligence/partnership efforts.
Communication excellence in project management; budget planning oversight of progress and periodic accruals and contract/PO/invoice coordination with finance; follow-ups and keeping activities on track meeting high quality deliverables in a timely manner.

Qualifications :

Ph.D. in analytical chemistry or related field with 3 years of experience or equivalent in the field of drug discovery and development.
Demonstrated problem-solving skills critical thinking and ability to quickly adapt and shift focus as needed.
Demonstrated ability to take initiative ownership and provide strategic input. A proven record of sustained laboratory achievement and innovation.
Extensive hands-on experience in analytical technologies including UHPLC GC LC-MS GC-MS SFC dissolution disintegration wet chemistry DSC TGA PSD XRPD spectroscopic and compendial methods. Thorough mechanistic understanding of underlying science and contemporary practice of various analytical technologies and development for new drug candidates in preclinical through early and late-stage clinical development.
Awareness and knowledge of cross-functional activities such as DMPK 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 CROs and CDMOs.
Experience in writing and reviewing product specifications method validation protocols/ reports analytical methods and development reports.
Working understanding of 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 communities.

Additional Information :

Remote Work :

Employment Type :

Full-time

Key Skills

Laboratory Experience
Mammalian Cell Culture
Biochemistry
Assays
Protein Purification
Research Experience
Next Generation Sequencing
Research & Development
cGMP
Cell Culture
Molecular Biology
Flow Cytometry

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About Company

ORIC Pharmaceuticals

ORIC Pharmaceuticals is a clinical stage biopharmaceutical company dedicated to improving patients’ lives by Overcoming Resistance In Cancer. ORIC’s clinical stage product candidates include ORIC-114, a brain penetrant inhibitor designed to selectively target EGFR and HER2 with high ... View more

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