Senior Manager, Manufacturing, Drug Product

The Senior Manager, Manufacturing, Drug Product will report to the Senior Director, Manufacturing and will be responsible for all aspects of Drug Product (DP) filling including the oversight and management of Contract Development and Manufacturing Organizations (CDMOs). Working with the CMC team and key personnel including Quality Assurance, Supply Chain, and Regulatory, the ideal candidate must be an outstanding leader with a proven track record of strategic planning and execution in drug product manufacturing having advanced molecules from late-stage to commercial manufacturing. 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:

• Develop, plan, and oversee drug product filling manufacturing programs, including projection of material requirements, budgets, and timelines.
• Manage and provide technical oversight and guidance to CDMOs for process technology transfer and optimization, and cGMP manufacture of drug product in support of ongoing clinical programs and commercial supply.
• Support lot release activities within the required timelines including closure of deviations, CAPAs, and product complaints.
• Execute plans in accordance with cGMP, ICH, and FDA regulations.
• Partner with and maintain regular contact with key stakeholders including Drug Substance, Analytical Sciences, Quality Assurance, Supply Chain, Regulatory Affairs, Finance, and Program Management.
• Write and review relevant sections for regulatory submissions including APRs/PQRs.
• Oversight of CPV implementation, data trending, and assessment of process capabilities.
• Prepare, review, or edit cGMP batch records, CMC regulatory and quality documents.
• Participate in vendor selection processes and perform site audits.

Qualifications:

• PhD/MS in relevant life sciences or engineering discipline preferred with a minimum of 5 years of Pharmaceutical/Biotechnology industry experience in late-stage process development or cGMP manufacturing operations of biologics, or BS in relevant life sciences or engineering discipline with a minimum of 8 years of Pharmaceutical/Biotechnology industry experience in late-stage process development or cGMP manufacturing operations of biologics.
• Expertise in drug product filling operations and process validation is required.
• Experience in CMC for biologics (specifically antibodies and fusion proteins) including broad knowledge of all aspects of CMC including process development, technology transfer, regulatory and quality requirements, analytical development, formulation, and drug product technologies.
• Experience in managing US/international CDMOs for the manufacture of cGMP drug product.
• Expertise in drug delivery device assembly process (e.g., autoinjector) is preferred but not required.
• Working knowledge of FDA and international cGMP regulatory guidelines and 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 starting base pay range is $158K. 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.