Senior Manager - QC Stability Management
Job Title: Senior Manager, QC Stability Management
Location: Remote
About Us:
Vera Therapeutics (Nasdaq: VERA), is a late clinical-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 weekly injection that blocks both B-cell Activating Factor (BAFF) and A Proliferation Inducing Ligand (APRIL), which stimulate B cells to produce autoantibodies contributing to certain autoimmune diseases, including IgA nephropathy. Vera is also considering evaluating the role of atacicept in other immunologic disorders. Additionally, Vera is developing VT-109, a novel, next-generation dual BAFF/APRIL inhibitor in preclinical development, and 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:
The Senior Manager, QC Stability Management, will join an experienced, fast-paced and collaborative team. The Senior Manager will report to the Associate Director of Analytical Sciences (Quality Control) and will manage stability programs, QC change control and deviations. In addition, the Senior Manager 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, Project Management, and with external CDMO and Contract Testing Laboratories, this position will ensure timely delivery of investigational product, drive process/product understanding, and enable commercial supply.
Responsibilities:
Work virtually with external partners to develop and manage stability programs, ensure compliance with regulatory guidelines
Manage stability data which includes analysis of data generated at multiple CDMOs and CTLs as well as publishing Vera stability reports, including interpretation of stability data to support product shelf life and storage conditions
Lead implementation of stability data management tool
Provide technical review of batch release and stability data
Collaborate with cross-functional teams including CDMOs and CTLs to manage stability sample inventory and coordinate shipments between different testing sites
Manage QC related change controls, deviations, and OOS investigations
Maintain Reference Standards and critical reagents for multiple CDMOs and CTLs
Review CDMO and CTL stability 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, and regulatory audits
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 with a focus in stability testing
Experience in developing and managing stability programs
Experience supporting analytical methods for release and stability testing across multiple technical areas (chromatography, bioassays, microbiological, etc.)
Experience managing large analytical data sets including method transfer, method validation, lot release, and stability data
Experience managing critical reagents
Strong knowledge of cGMPs and with international regulatory guidelines for analytical methods and stability studies
Experience authoring and reviewing analytical methods, technical reports, and regulatory filings
Experience working with CDMOs and CTLs
Experience with statistical analysis and statistical software is a plus
Detail-oriented with excellent analytical and problem-solving skills
Effective communication and documentation skills
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 begins at $145,000. 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.
Fraud Alert
To all candidates: your personal information and online safety are a top priority for us. At Vera Therapeutics, recruiters only direct candidates to apply through our official career page at https://veratx.com/careers/.
Recruiters will always contact you using the domain of veratx.com. We will never request payments, ask for financial account information or sensitive information like social security numbers. If you are unsure if a message is from Vera Therapeutics, please email human resources.
About the job
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Senior Manager - QC Stability Management
Job Title: Senior Manager, QC Stability Management
Location: Remote
About Us:
Vera Therapeutics (Nasdaq: VERA), is a late clinical-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 weekly injection that blocks both B-cell Activating Factor (BAFF) and A Proliferation Inducing Ligand (APRIL), which stimulate B cells to produce autoantibodies contributing to certain autoimmune diseases, including IgA nephropathy. Vera is also considering evaluating the role of atacicept in other immunologic disorders. Additionally, Vera is developing VT-109, a novel, next-generation dual BAFF/APRIL inhibitor in preclinical development, and 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:
The Senior Manager, QC Stability Management, will join an experienced, fast-paced and collaborative team. The Senior Manager will report to the Associate Director of Analytical Sciences (Quality Control) and will manage stability programs, QC change control and deviations. In addition, the Senior Manager 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, Project Management, and with external CDMO and Contract Testing Laboratories, this position will ensure timely delivery of investigational product, drive process/product understanding, and enable commercial supply.
Responsibilities:
Work virtually with external partners to develop and manage stability programs, ensure compliance with regulatory guidelines
Manage stability data which includes analysis of data generated at multiple CDMOs and CTLs as well as publishing Vera stability reports, including interpretation of stability data to support product shelf life and storage conditions
Lead implementation of stability data management tool
Provide technical review of batch release and stability data
Collaborate with cross-functional teams including CDMOs and CTLs to manage stability sample inventory and coordinate shipments between different testing sites
Manage QC related change controls, deviations, and OOS investigations
Maintain Reference Standards and critical reagents for multiple CDMOs and CTLs
Review CDMO and CTL stability 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, and regulatory audits
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 with a focus in stability testing
Experience in developing and managing stability programs
Experience supporting analytical methods for release and stability testing across multiple technical areas (chromatography, bioassays, microbiological, etc.)
Experience managing large analytical data sets including method transfer, method validation, lot release, and stability data
Experience managing critical reagents
Strong knowledge of cGMPs and with international regulatory guidelines for analytical methods and stability studies
Experience authoring and reviewing analytical methods, technical reports, and regulatory filings
Experience working with CDMOs and CTLs
Experience with statistical analysis and statistical software is a plus
Detail-oriented with excellent analytical and problem-solving skills
Effective communication and documentation skills
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 begins at $145,000. 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.
Fraud Alert
To all candidates: your personal information and online safety are a top priority for us. At Vera Therapeutics, recruiters only direct candidates to apply through our official career page at https://veratx.com/careers/.
Recruiters will always contact you using the domain of veratx.com. We will never request payments, ask for financial account information or sensitive information like social security numbers. If you are unsure if a message is from Vera Therapeutics, please email human resources.