Senior Manager - Analytical Sciences
To see similar active jobs please follow this link: Remote Management jobs
Title: Senior Manager, Analytical Sciences
Location: Remote
About Us:
Vera Therapeutics (Nasdaq: VERA), is a late-stage biotechnology company focused on developing treatments for serious immunological diseases. Vera’s mission is to advance treatments that target the source of immunologic diseases in order to change the standard of care for patients. Vera’s lead product candidate is atacicept, a fully humanized fusion protein self-administered at home as a subcutaneous injection once weekly that blocks both B-cell Activating Factor (BAFF) and A Proliferation Inducing Ligand (APRIL), which stimulate B cells and plasma cells to produce galactose-deficient IgA1 (Gd-IgA1) and associated autoantibodies, which together form immune complexes that are fundamental in the pathogenesis of IgA nephropathy (IgAN). Vera is also considering evaluating the role of atacicept in other immunologic disorders. Additionally, Vera is developing MAU868, a monoclonal antibody designed to neutralize infection with BK Virus, a polyomavirus that can have devastating consequences in certain settings such as kidney transplant. For more information, please visit: www.veratx.com.
Our values are the cornerstone of our culture. Our values inspire us every day and guide everything we do—from how we hire great people, to advancing our mission together, to achieving our ultimate goal to improve medical treatment for patients suffering from immunological diseases.
Position Summary:
We are seeking a Senior Manager, Analytical Sciences to join an experienced, fast-paced and collaborative team. The Senior Manager, Analytical Sciences will report to the Associate Director, Analytical Sciences (Quality Control) and will manage method validation, method transfer, and stability programs. In addition, the Senior Manager, Analytical Sciecnes will support all aspects of QC functions for antibody and fusion protein products. Working with the CMC team and key personnel including Quality Assurance, Regulatory, and Project Management, and with external CDMO and Contract Testing Laboratories, this position will ensure timely delivery of investigational products, drive process/product understanding, and enable commercial supply.
Responsibilities:
Work virtually with external partners to develop, transfer, qualify and validate the analytical methods used for in-process testing, drug substance and drug product release, demonstration of comparability, and stability testing.
Manage data and associated activities for method transfer, validation, batch release, and stability for in-process, drug substance, and drug product at CMOs/CTLS.
Maintain Reference Standards and critical reagents for multiple CMOs and third-party testing sites.
Review CMO and third-party qualification/validation protocols, test procedures, raw data, and technical reports.
Author technical protocols, reports, and analytical sections for regulatory filings.
Contribute to due diligence activities, gap analysis, deviations, and OOS investigations.
Qualifications:
MS or BS in Chemistry, Biochemistry, or related discipline with a minimum of 6 years of experience in clinical-stage biopharma with a proven technical track record in Quality Control.
Experience developing, implementing, or supporting analytical methods for release, stability, and extended characterization testing across multiple technical areas (chromatography, bioassays, spectroscopy, etc.).
Experience managing large analytical data sets including method transfer, method validation, lot release, and stability data.
Experience managing critical reagents.
Familiarity with international regulatory guidelines for analytical methods.
Experience authoring and reviewing analytical methods, technical reports, and regulatory filings.
Experience working with CDMOs and third-party testing sites.
Experience with statistical analysis and statistical software is a plus.
Excellent interpersonal skills and demonstrated ability to work well in a team-oriented environment.
Vera Therapeutics Inc. is an equal-opportunity employer.
Vera Therapeutics is committed to fair and equitable compensation practices and we strive to provide employees with total compensation packages that are market competitive. For this role, the anticipated base pay range is $ - $. The exact base pay offered for this role will depend on various factors, including but not limited to the candidate’s geography, qualifications, skills, and experience.
At Vera, base pay is only one part of your total compensation package. The successful candidate will be eligible for an annual performance incentive bonus, new hire equity, and ongoing performance-based equity. Vera Therapeutics also offers various benefits offerings, including, but not limited to, medical, dental, and vision insurance, 401k match, flexible time off, and a number of paid holidays.
Notice to Recruiters/Staffing Agencies
Recruiters and staffing agencies should not contact Vera Therapeutics through this page. All recruitment vendors (search firms, recruitment agencies, and staffing companies) are prohibited from contacting our hiring manager(s), executive team members, or employees.
We require that all recruiters and staffing agencies have a fully executed, formal written agreement on file.
Vera Therapeutics’ receipt or acceptance of an unsolicited resume submitted by a vendor organization to this website or employee does not constitute an actual or implied contract between Vera Therapeutics and such organization and will be considered unsolicited and Vera Therapeutics will not be responsible for related fees.
About the job
Senior Manager - Analytical Sciences
To see similar active jobs please follow this link: Remote Management jobs
Title: Senior Manager, Analytical Sciences
Location: Remote
About Us:
Vera Therapeutics (Nasdaq: VERA), is a late-stage biotechnology company focused on developing treatments for serious immunological diseases. Vera’s mission is to advance treatments that target the source of immunologic diseases in order to change the standard of care for patients. Vera’s lead product candidate is atacicept, a fully humanized fusion protein self-administered at home as a subcutaneous injection once weekly that blocks both B-cell Activating Factor (BAFF) and A Proliferation Inducing Ligand (APRIL), which stimulate B cells and plasma cells to produce galactose-deficient IgA1 (Gd-IgA1) and associated autoantibodies, which together form immune complexes that are fundamental in the pathogenesis of IgA nephropathy (IgAN). Vera is also considering evaluating the role of atacicept in other immunologic disorders. Additionally, Vera is developing MAU868, a monoclonal antibody designed to neutralize infection with BK Virus, a polyomavirus that can have devastating consequences in certain settings such as kidney transplant. For more information, please visit: www.veratx.com.
Our values are the cornerstone of our culture. Our values inspire us every day and guide everything we do—from how we hire great people, to advancing our mission together, to achieving our ultimate goal to improve medical treatment for patients suffering from immunological diseases.
Position Summary:
We are seeking a Senior Manager, Analytical Sciences to join an experienced, fast-paced and collaborative team. The Senior Manager, Analytical Sciences will report to the Associate Director, Analytical Sciences (Quality Control) and will manage method validation, method transfer, and stability programs. In addition, the Senior Manager, Analytical Sciecnes will support all aspects of QC functions for antibody and fusion protein products. Working with the CMC team and key personnel including Quality Assurance, Regulatory, and Project Management, and with external CDMO and Contract Testing Laboratories, this position will ensure timely delivery of investigational products, drive process/product understanding, and enable commercial supply.
Responsibilities:
Work virtually with external partners to develop, transfer, qualify and validate the analytical methods used for in-process testing, drug substance and drug product release, demonstration of comparability, and stability testing.
Manage data and associated activities for method transfer, validation, batch release, and stability for in-process, drug substance, and drug product at CMOs/CTLS.
Maintain Reference Standards and critical reagents for multiple CMOs and third-party testing sites.
Review CMO and third-party qualification/validation protocols, test procedures, raw data, and technical reports.
Author technical protocols, reports, and analytical sections for regulatory filings.
Contribute to due diligence activities, gap analysis, deviations, and OOS investigations.
Qualifications:
MS or BS in Chemistry, Biochemistry, or related discipline with a minimum of 6 years of experience in clinical-stage biopharma with a proven technical track record in Quality Control.
Experience developing, implementing, or supporting analytical methods for release, stability, and extended characterization testing across multiple technical areas (chromatography, bioassays, spectroscopy, etc.).
Experience managing large analytical data sets including method transfer, method validation, lot release, and stability data.
Experience managing critical reagents.
Familiarity with international regulatory guidelines for analytical methods.
Experience authoring and reviewing analytical methods, technical reports, and regulatory filings.
Experience working with CDMOs and third-party testing sites.
Experience with statistical analysis and statistical software is a plus.
Excellent interpersonal skills and demonstrated ability to work well in a team-oriented environment.
Vera Therapeutics Inc. is an equal-opportunity employer.
Vera Therapeutics is committed to fair and equitable compensation practices and we strive to provide employees with total compensation packages that are market competitive. For this role, the anticipated base pay range is $ - $. The exact base pay offered for this role will depend on various factors, including but not limited to the candidate’s geography, qualifications, skills, and experience.
At Vera, base pay is only one part of your total compensation package. The successful candidate will be eligible for an annual performance incentive bonus, new hire equity, and ongoing performance-based equity. Vera Therapeutics also offers various benefits offerings, including, but not limited to, medical, dental, and vision insurance, 401k match, flexible time off, and a number of paid holidays.
Notice to Recruiters/Staffing Agencies
Recruiters and staffing agencies should not contact Vera Therapeutics through this page. All recruitment vendors (search firms, recruitment agencies, and staffing companies) are prohibited from contacting our hiring manager(s), executive team members, or employees.
We require that all recruiters and staffing agencies have a fully executed, formal written agreement on file.
Vera Therapeutics’ receipt or acceptance of an unsolicited resume submitted by a vendor organization to this website or employee does not constitute an actual or implied contract between Vera Therapeutics and such organization and will be considered unsolicited and Vera Therapeutics will not be responsible for related fees.