BioSpace
aTyr Pharma- Senior Scientist, CMC Analytical Development and Val...
BioSpace - San Diego, California, United States, 92189
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aTyr Pharma- Senior Scientist, CMC Analytical Development and Validation
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aTyr Pharma- Senior Scientist, CMC Analytical Development and Validation
role at
BioSpace . We are seeking a highly motivated and experienced individual to be a CMC Analytical Development and Validation Senior Scientist within our Technical Operations Group. This role primarily supports late-phase and commercial analytical activities for aTyr’s efzofitimod program, a recombinant Fc-fusion biologic in Phase III trials. Responsibilities include supporting method lifecycle management across cGMP contract service providers (CSPs), including establishment, transfer, qualification, validation, and oversight of Drug Substance and Drug Product methods. Reporting to the Head of the CMC Analytical Team, you will design, contract, and oversee analytical work. Success depends on strong analytical expertise in method transfer and validation within GMP environments, project management skills, and the ability to influence external organizations. Ideal candidates are experienced protein analytical chemists with backgrounds in QC, method validation, and vendor management, thriving in a small, dynamic setting. Primary Responsibilities
Participate in vetting and selecting new analytical CSPs. Develop timelines and strategies for analytical transfer activities. Support analytical contract scoping and review at CSPs. Manage establishment of analytical methods at new CSP labs. Manage Method Transfer studies per USP 1224. Manage Method Validation studies per ICH Q2 R2. Manage Compendial Method Verification studies per USP 1226. Support Method Lifecycle Management, track analytical data, and troubleshoot validated methods. Review and approve GMP laboratory documents. Ensure testing performance and data integrity from CSPs. Contribute to regulatory documentation sections. Assist in CMC budgeting and timeline planning. Occasional travel to CSP labs (up to 5%). Qualifications
B.S., M.S., or Ph.D. in Analytical Chemistry or related field. At least 5 years of experience in CMC Analytical fields (AD, QC) in biotech/pharma. 2-3 years bench QC testing and/or method validation in GMP, plus 2-3 years managing analytical projects at CSPs or in-house. Hands-on experience with protein analytical techniques (HPLC/UPLC, CE, icIEF, ELISA, Mass Spectrometry). Understanding of ICH and FDA regulatory requirements for Method Validation, Transfer, and cGMP testing. Experience managing cGMP contract service providers is a plus. Excellent communication skills, independence, initiative, and problem-solving abilities. Additional Information
The salary range is $140,000-$165,000 annually, with additional benefits including stock options, Employee Stock Purchase Plan, and comprehensive health plans. For more info, visit
www.atyrpharma.com . We are an equal opportunity employer committed to a diverse and inclusive workplace. Reasonable accommodations will be provided in accordance with applicable laws. Job Details
Seniority level: Mid-Senior level Employment type: Full-time Job function: Research, Analysis, IT Industries: Biotechnology, Pharmaceuticals
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Join to apply for the
aTyr Pharma- Senior Scientist, CMC Analytical Development and Validation
role at
BioSpace . We are seeking a highly motivated and experienced individual to be a CMC Analytical Development and Validation Senior Scientist within our Technical Operations Group. This role primarily supports late-phase and commercial analytical activities for aTyr’s efzofitimod program, a recombinant Fc-fusion biologic in Phase III trials. Responsibilities include supporting method lifecycle management across cGMP contract service providers (CSPs), including establishment, transfer, qualification, validation, and oversight of Drug Substance and Drug Product methods. Reporting to the Head of the CMC Analytical Team, you will design, contract, and oversee analytical work. Success depends on strong analytical expertise in method transfer and validation within GMP environments, project management skills, and the ability to influence external organizations. Ideal candidates are experienced protein analytical chemists with backgrounds in QC, method validation, and vendor management, thriving in a small, dynamic setting. Primary Responsibilities
Participate in vetting and selecting new analytical CSPs. Develop timelines and strategies for analytical transfer activities. Support analytical contract scoping and review at CSPs. Manage establishment of analytical methods at new CSP labs. Manage Method Transfer studies per USP 1224. Manage Method Validation studies per ICH Q2 R2. Manage Compendial Method Verification studies per USP 1226. Support Method Lifecycle Management, track analytical data, and troubleshoot validated methods. Review and approve GMP laboratory documents. Ensure testing performance and data integrity from CSPs. Contribute to regulatory documentation sections. Assist in CMC budgeting and timeline planning. Occasional travel to CSP labs (up to 5%). Qualifications
B.S., M.S., or Ph.D. in Analytical Chemistry or related field. At least 5 years of experience in CMC Analytical fields (AD, QC) in biotech/pharma. 2-3 years bench QC testing and/or method validation in GMP, plus 2-3 years managing analytical projects at CSPs or in-house. Hands-on experience with protein analytical techniques (HPLC/UPLC, CE, icIEF, ELISA, Mass Spectrometry). Understanding of ICH and FDA regulatory requirements for Method Validation, Transfer, and cGMP testing. Experience managing cGMP contract service providers is a plus. Excellent communication skills, independence, initiative, and problem-solving abilities. Additional Information
The salary range is $140,000-$165,000 annually, with additional benefits including stock options, Employee Stock Purchase Plan, and comprehensive health plans. For more info, visit
www.atyrpharma.com . We are an equal opportunity employer committed to a diverse and inclusive workplace. Reasonable accommodations will be provided in accordance with applicable laws. Job Details
Seniority level: Mid-Senior level Employment type: Full-time Job function: Research, Analysis, IT Industries: Biotechnology, Pharmaceuticals
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