Senior Manager - Drug Product Development
To see similar active jobs please follow this link: Remote Management jobs
Title: Senior Manager, Drug Product Development
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, Drug Product Development will report to the Associate Director of Drug Product and Formulation Development and will be responsible for leading engineering activities needed to establish new drug product filling lines for GMP manufacturing. Working as part of the CMC team and collaborating with key personnel, the candidate will work with CDMOs to establish new filling lines for the growing portfolio of projects at Vera.
Responsibilities:
Working as part of a CMC team to support the development of new therapeutics.
Provide technical expertise to cross-functional teams on drug product filling of vials, syringes, and other primary containers.
Lead process development and technology transfers to external manufacturing sites.
Design and manage manufacturing studies to bring new fill/finish lines into operation.
Provide input for scheduling and planning of filling operations.
Drafting reports and study summaries in support of regulatory filings.
Communicating project updates and requirements to team members.
Qualifications:
Bachelor’s degree in chemical engineering, biochemistry, or relevant discipline; and 6+ years of experience in drug development.
In depth, hands-on experience developing and validating DP processes, with knowledge of fluid dynamics and aseptic procedures.
Relevant experience managing vendors and technology transfers.
Proficiency with MS Word, PowerPoint and Excel.
Committed to producing high quality and timely deliverables.
Work independently and efficiently.
Demonstrate flexibility, patience, and good verbal, written, and interpersonal communication skills.
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 $156,000. 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
Senior Manager - Drug Product Development
To see similar active jobs please follow this link: Remote Management jobs
Title: Senior Manager, Drug Product Development
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, Drug Product Development will report to the Associate Director of Drug Product and Formulation Development and will be responsible for leading engineering activities needed to establish new drug product filling lines for GMP manufacturing. Working as part of the CMC team and collaborating with key personnel, the candidate will work with CDMOs to establish new filling lines for the growing portfolio of projects at Vera.
Responsibilities:
Working as part of a CMC team to support the development of new therapeutics.
Provide technical expertise to cross-functional teams on drug product filling of vials, syringes, and other primary containers.
Lead process development and technology transfers to external manufacturing sites.
Design and manage manufacturing studies to bring new fill/finish lines into operation.
Provide input for scheduling and planning of filling operations.
Drafting reports and study summaries in support of regulatory filings.
Communicating project updates and requirements to team members.
Qualifications:
Bachelor’s degree in chemical engineering, biochemistry, or relevant discipline; and 6+ years of experience in drug development.
In depth, hands-on experience developing and validating DP processes, with knowledge of fluid dynamics and aseptic procedures.
Relevant experience managing vendors and technology transfers.
Proficiency with MS Word, PowerPoint and Excel.
Committed to producing high quality and timely deliverables.
Work independently and efficiently.
Demonstrate flexibility, patience, and good verbal, written, and interpersonal communication skills.
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 $156,000. 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.