VP, Technical Process Development

Summary

Join Neumora, a biopharmaceutical company revolutionizing brain disease treatment, as the SVP/VP, Technical Process Development. Lead comprehensive compound-specific development strategies from Phase I to commercialization, bridging Discovery and CMC. Provide technical leadership to interdisciplinary teams, overseeing drug substance, drug product, analytical, quality, regulatory, and clinical/commercial supply aspects. Manage multiple assets, vendor relationships, and project timelines. Collaborate with various functional areas to achieve optimal development and business results. This role requires a PhD in Chemistry or a related field, 15+ years of pharmaceutical experience, and extensive knowledge of drug substance development and regulatory submissions. Neumora offers competitive benefits, including comprehensive health insurance, a 401(k) plan, company equity, generous paid time off, and a discretionary year-end bonus.

Requirements

• PhD required in Chemistry or related scientific discipline
• At least 15+ years of relevant technical development experience in the pharmaceutical industry. Small molecule development experience is a must
• Extensive knowledge of drug substance development, process chemistry, process optimization, manufacturing including transfer and scale-up and validation
• Hands-on experience in the authoring of global regulatory submissions (e.g., IND, IMPD, NDA)
• Deep understanding of analytical and formulation development and a proven track record in CMC development for clinical stage programs
• Solid understanding of how pharmaceutical development integrates and partners with Quality, Regulatory CMC, Non-Clinical, Clinical, and other functional areas
• Demonstrated success leading high-performing teams through complex challenges, with proven ability to set clear direction, develop talent, foster collaboration, and drive measurable results while cultivating an inclusive culture where diverse perspectives are valued
• Excellent verbal and written communication skills and the ability to effectively work across levels, functions, and with both internal and external stakeholders
• Strong sense for value of investment, ability to manage ambiguity and make decisions with limited information

Responsibilities

• Lead the DS/DP process development team including building out the team as needed to ensure strong development skills exist across various assets in development
• Provide technical leadership and subject matter expertise to drug substance development from R&D through commercial readiness (chemical development, manufacturing process development, process optimization, process transfer and scale-up, validation and launch)
• Troubleshoot technical development and manufacturing challenges at the vendor (e.g., process development challenges, manufacturing issues and investigations) in collaboration with internal stakeholders
• Lead end-to-end technology process transfers to and from vendors and business partners
• Manage multiple assets internally and at the vendor, ranging from development, First-in-Human, and pivotal clinical studies, to intended registrational studies and commercial launch including but not limited to vendor relationships and oversight, contracts, project timelines, budget, and internal communications to appropriate stakeholders
• Actively collaborate with other functional areas (Clinical, Commercial, Regulatory, Clinical Pharmacology, Toxicology, Quality, etc.) to achieve the best development and business results for the company
• Communicate and partner effectively with functional areas within Tech Ops and other stakeholders (Quality, Toxicology, DMPK, Clinical Pharmacology, Regulatory CMC, Clinical Operations, etc.) to define and execute development strategy for the project incorporating QbD principles at all stages of development
• Identify and escalate key issues and risks as well as resource allocation needs, as appropriate
• Critically review relevant documents, including development reports, technical documents, CMC regulatory submissions, briefing booklets, information requests, etc
• Lead or contribute to continuous improvement initiatives across the enterprise
• Partner with the Business Development group to support or lead Due Diligence evaluations and activities associated with bringing in new assets and will partner with alliance management, as necessary

Preferred Qualifications

Commercial readiness and launch experience desirable

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
• 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