Senior Manager, Early-stage Biologics Development, CMC

Job Description

Title: Senior Manager, Early-Stage Biologics Development, CMC

Location: Brisbane, CA

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, Early-stage Biologics Development, CMC will be responsible for all early- stage aspects of Drug Substance (DS) manufacturing with expertise in Cell line development and upstream processing (CHO cell culture and protein production) including the oversight and management of CROs/CDMOs. Working with the CMC team and other functions such as Research, QA, and Regulatory, the ideal candidate must be an outstanding leader with a proven track record of strategic planning and execution having advanced molecules from pre-clinical development to clinical trials. In addition, the role requires authoring, reviewing, and editing of CMC related regulatory submissions and associated quality documents. The candidate must have exceptional organizational and communication skills, be capable of communicating strategic plans to upper management, summarize data, and effectively manage interactions with stakeholders across functions.

Responsibilities:

• Serve as a subject matter expert and lead for all aspects of lead drug candidate development, including CMC developability, cell line development, process development, and GLP material generation.
• Develop, plan, and oversee cell line and DS development programs, including planning aspects such as projection of material requirements, budgets, and timelines.
• Manage Contract Research Organizations (CROs) and Contract Development and Manufacturing Organizations (CDMOs) for Developability, Cell line development, process development and optimization, non-GMP and cGMP manufacture of DS in support of clinical programs.
• Execute plans in accordance with cGMP, ICH, and FDA regulations.
• Partner with and maintain regular contact with key stakeholders including Research, Clinical Pharm, Analytical Science, Drug product, Quality Assurance, Regulatory Affairs, Supply chain, Finance, and Program Management. Write and review relevant sections for regulatory submissions.
• Participate and represent CMC Process Development in project teams.
• Prepare, review, or edit cGMP batch records, CMC regulatory and quality documents.

Qualifications:

• PhD/MS in relevant life sciences or engineering discipline with 5+ years of Pharmaceutical/Biotechnology industry experience in Early-stage process development of biologics, technology transfer, and cGMP manufacturing operations, or
• BS in relevant life sciences or engineering discipline with 8+ years of Pharmaceutical/Biotechnology industry experience in Early phase process development of biologics, technology transfer, and cGMP manufacturing operations.
• Expertise in molecule biology, cell line development, and process development (CHO cell culture and protein production) is required.
• Experience in managing US/international CDMOs for the manufacture of non-GMP and cGMP grade DS materials.
• A broad knowledge of all aspects of CMC including cell line development, process development, technology transfer, regulatory and quality requirements, analytical development, formulation, and drug product technologies.
• Experience with regulatory, QA, and cGMP requirements for biologics.
• Experience with IND filings; knowledge of relevant FDA regulations and guidelines is required. Working knowledge of ICH and FDA guidelines and regulations.
• Proven leadership and cross-functional management of CMC-related programs. Track record of successfully driving and managing programs, overcoming challenges, and managing risks.
• Critical thinking and problem-solving skills with ability to drive risk-based decision making.
• Strong organizational and project management skills, including proficient use of MS Project and other tools.
• Excellent communication and interpersonal skills in working across the organization.

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 $153,000 - $162,000. 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.

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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.