VP, Drug Substance Manufacturing - Validation

October 13

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Neumora

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Description

•At Neumora, we are pushing the boundaries of science and technology to revolutionize the way patients with brain disease are treated. •The VP, Drug Substance Manufacturing and Validation is responsible for leading chemical development, scale-up of drug substance and process validation for NDA readiness, and will also lead all aspects of commercial manufacturing with CDMO and transfer validated DS manufacturing to secondary CDMO. •Lead drug substance manufacturing, scale-up and process validation for late-stage program. •Lead DS manufacturing campaigns to supply for clinical trials and commercial launch readiness. •Develop and optimize scalable chemical processes for the synthesis of drug substance, focusing on efficiency, yield, and purity. •Critically review and approve relevant documents, including but not limited to all manufacturing, scale-up and validation protocols, reports and plans. •Manage CDMO relationship with their technical team to enable on-time deliverables for DS batches. •Identify secondary CDMO to transfer DS manufacturing process; lead validation of the process at secondary CDMO. •Provide input for NDA readiness; author/review relevant DS reports and DS sections of the NDA. •Maintain awareness of relevant new and current technologies, capabilities, and effectively share this knowledge with others. •Collaborate with cross-functional teams, including but not limited to CMC, analytical development, formulation development, quality assurance, and regulatory affairs to ensure seamless project progressions. •Represent DS manufacturing at CMC team and coordinate with the CMC team on program timelines and deliverables. •Develop and manage the DS budget and implement continuous improvement initiatives to reduce COGS and improve product quality. •Prepare long-term DS manufacturing process and network strategy to support 3-year supply projections.

Requirements

•Advanced degree in relevant scientific discipline; MS or PhD in Chemistry or Chemical Engineering preferred •15+ years of relevant small molecule process manufacturing experience •Proven track record of manufacturing process development, process validation and process transfer leading to commercial use •Deep experience in drafting, reviewing and filing regulatory submissions (e.g. IND, IMPD, NDA, etc.) •Hands-on experience in pharmaceutical manufacturing and chemical process development •Advanced team leadership experience (direct leadership and matrix leadership) with the ability to communicate complex ideas succinctly and provide a strategic vision •CDMO relationship management, providing technical guidance and escalating issues to keep timelines and deliverables •Strong communication, creativity, organizational, and project management skills •Ability to collaborate effectively within and across functional areas •Advanced knowledge or experience in a specialized scientific area •Discipline to drive results •Commercial launch and supply experience desirable •20-30% travel required

Benefits

•Medical, dental, vision, and life insurance •401(k) plan: Neumora matches 50% of an employee’s eligible contribution, up to the first 6% of salary (up to 3% employer contribution) •Company Equity (New Hire Awards, Annual Awards, ESPP) •Accrued Vacation Days: 15 days per year •Sick Days: 10 days per year •Company Holidays: 13 days plus summer recharge week in July and winter shutdown in December •Paid Medical Leave, Paid New Parent Bonding Leave, Paid Family Leave, paid short-term and long-term disability •Discretionary year-end bonus