Title: Senior Manager, Process Development, DownstreamLocation: Brisbane, CAAbout 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.Position Summary:The Senior Manager, Process Development, Downstream will be responsible for all aspects of Drug Substance (DS) manufacturing with expertise in downstream processing (CHO cell culture and protein production) including the oversight and management of Contract Development and Manufacturing Organizations (CDMOs). Working with the CMC team and other key functions such as project management, 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 clinical to late-stage/commercial manufacturing. In addition, the role requires authoring, reviewing, and editing of CMC related regulatory submissions (e.g., BLA) 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:Develop, plan, and oversee downstream DS process development and manufacturing programs, including planning aspects projection of DS material requirements, budgets, and timelines.Manage and provide technical oversight/guidance to CDMO teams for process technology transfer and optimization, non-GMP and cGMP manufacture of DS in support of ongoing clinical programs.Execute plans in accordance with cGMP, ICH, and FDA regulations.Partner with and maintain regular contact with key stakeholders including Drug Product, Analytical sciences, Quality Assurance, Regulatory Affairs, Supply chain, Finance, and Program Management. Write and review relevant sections for regulatory submissions.Prepare, review, or edit cGMP batch records, change controls, deviations, CMC regulatory and quality documents.Participate and represent CMC Process Development in project teams.Qualifications:PhD/MS in relevant life sciences or engineering discipline with 5+ years of Pharmaceutical/Biotechnology industry experience in process development of biologics, technology transfer, and cGMP manufacturing operations, orBS in relevant life sciences or engineering discipline with 8+ years of Pharmaceutical/Biotechnology industry experience in process development of biologics, technology transfer, and cGMP manufacturing operations.Thorough understanding of downstream purification process development for therapeutic proteins (in particular, antibody and fusion proteins).Hands-on experience with unit operations including scale-up, transfer to GMP manufacturing, and process validation.Experience in managing US/international CDMOs for the manufacture of non-GMP and cGMP DS. Working knowledge of FDA and international cGMP regulation guidelines. Experience with regulatory submissions.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 $146,000 - $170,000. 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.
#J-18808-Ljbffr