Remote VP Drug Substance Manufacturing and Validation

Summary

Join Neumora Therapeutics as we push the boundaries of science and technology to revolutionize brain disease treatment. We're seeking a VP, Drug Substance Manufacturing and Validation to lead chemical development, scale-up, process validation, and commercial manufacturing.

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

Responsibilities

• 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.  Represent Neumora as the Subject Matter Expert internally and with the CDMO
• 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

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)
• Annual paid time off
• 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
• Leave of Absence: Paid Medical Leave, Paid New Parent Bonding Leave, Paid Family Leave, paid short-term and long-term disability
• Discretionary year-end bonus