Director, Bioanalytical Sciences
To see similar active jobs please follow this link: Remote Management jobs
Title: Director, Bioanalytical 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 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 auto-antibodies which together form immune complexes which are fundamental in the pathogenesis of IgA nephropathy (IgAN). In addition, 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 Director, Bioanalytical Sciences, to join an experienced, fast-paced and collaborative team at Vera Therapeutics. The position will report to the Executive Director, Bioanalytical Sciences, and will be part of the PK, immunogenicity and biomarker assay development and validation function at Vera Therapeutics. The individual will be a key contributor to all aspects of bioanalytical assays for our antibody and fusion protein products. Working with key stakeholders in the Clinical Pharmacology and Analytical Sciences teams and key personnel from functions including Clinical Research, Clinical Operations, Biostatistics, Quality Assurance, Regulatory, and Project Management, and with CROs, this individual will establish robust bioanalytical methods to support clinical studies and enable global regulatory approvals of our products.
Responsibilities:
Work with the clinical research team to design and execute bioanalytical aspects (e.g., PK, ADA, and biomarkers) of clinical studies.
Work with CROs to develop, validate, and maintain bioanalytical methods supporting Vera’s clinical studies.
Review validation protocols, test procedures, raw data, and technical reports to ensure scientific integrity and compliance with regulatory requirements.
Collaborate with Clinical Operations, Clinical Data management, and Biostatistics functions to ensure timely collection of high-quality data to support clinical studies.
Represent the bioanalytical function to various cross-functional groups
Author memos, protocols, reports, and analytical sections for regulatory filings.
Participate in selection or CROs and provide input on timelines, budget, shipments, and inventory managements.
Support Quality audits, deviations, and troubleshooting activities.
Engage in complex and large-scale deliverables and initiatives to consistently successful and timely execution.
Deliver more than is expected by driving a culture of innovation, novel thinking, and continuous improvement across own area that serves as a model for other areas across own function to follow.
Qualifications:
PhD in Chemistry, Biochemistry, or related discipline with 4+ years of experience in pharma/biotech with strong scientific acumen and experience in the field of bioanalysis and biomarkers.
Demonstrated expertise in PK assay development, validation by hybrid LBA-LC-MS/MS methods AND substantial experience in ADA assay development and validation.
Experience in bioanalytical interpretation of immunogenicity results.
Expertise in development and validation ligand binding and cell-based neutralizing assays.
Ability to troubleshoot complex assays in real time.
Experience authoring and reviewing methods, validation protocols and reports, and regulatory filings, in particular authoring relevant sections of BLA.
Solid expertise in the interpretation and application of international regulatory guidelines for bioanalytical methods.
Wide-ranging experience managing global CROs, including in China.
Expertise with biomarker discovery for kidney/autoimmune disease is strongly desired.
Proven track record of achieving complex strategic goals and objectives despite highly challenging circumstances.
Helps shape and positively influence our culture.
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 $194,000 - $224,000. 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.
About the job
Director, Bioanalytical Sciences
To see similar active jobs please follow this link: Remote Management jobs
Title: Director, Bioanalytical 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 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 auto-antibodies which together form immune complexes which are fundamental in the pathogenesis of IgA nephropathy (IgAN). In addition, 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 Director, Bioanalytical Sciences, to join an experienced, fast-paced and collaborative team at Vera Therapeutics. The position will report to the Executive Director, Bioanalytical Sciences, and will be part of the PK, immunogenicity and biomarker assay development and validation function at Vera Therapeutics. The individual will be a key contributor to all aspects of bioanalytical assays for our antibody and fusion protein products. Working with key stakeholders in the Clinical Pharmacology and Analytical Sciences teams and key personnel from functions including Clinical Research, Clinical Operations, Biostatistics, Quality Assurance, Regulatory, and Project Management, and with CROs, this individual will establish robust bioanalytical methods to support clinical studies and enable global regulatory approvals of our products.
Responsibilities:
Work with the clinical research team to design and execute bioanalytical aspects (e.g., PK, ADA, and biomarkers) of clinical studies.
Work with CROs to develop, validate, and maintain bioanalytical methods supporting Vera’s clinical studies.
Review validation protocols, test procedures, raw data, and technical reports to ensure scientific integrity and compliance with regulatory requirements.
Collaborate with Clinical Operations, Clinical Data management, and Biostatistics functions to ensure timely collection of high-quality data to support clinical studies.
Represent the bioanalytical function to various cross-functional groups
Author memos, protocols, reports, and analytical sections for regulatory filings.
Participate in selection or CROs and provide input on timelines, budget, shipments, and inventory managements.
Support Quality audits, deviations, and troubleshooting activities.
Engage in complex and large-scale deliverables and initiatives to consistently successful and timely execution.
Deliver more than is expected by driving a culture of innovation, novel thinking, and continuous improvement across own area that serves as a model for other areas across own function to follow.
Qualifications:
PhD in Chemistry, Biochemistry, or related discipline with 4+ years of experience in pharma/biotech with strong scientific acumen and experience in the field of bioanalysis and biomarkers.
Demonstrated expertise in PK assay development, validation by hybrid LBA-LC-MS/MS methods AND substantial experience in ADA assay development and validation.
Experience in bioanalytical interpretation of immunogenicity results.
Expertise in development and validation ligand binding and cell-based neutralizing assays.
Ability to troubleshoot complex assays in real time.
Experience authoring and reviewing methods, validation protocols and reports, and regulatory filings, in particular authoring relevant sections of BLA.
Solid expertise in the interpretation and application of international regulatory guidelines for bioanalytical methods.
Wide-ranging experience managing global CROs, including in China.
Expertise with biomarker discovery for kidney/autoimmune disease is strongly desired.
Proven track record of achieving complex strategic goals and objectives despite highly challenging circumstances.
Helps shape and positively influence our culture.
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 $194,000 - $224,000. 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.