VP, Manufacturing Science and Technology (MSAT)

The VP of Manufacturing Science and Technology is a hands-on leader focusing on product development, scale-up, and commercialization across the portfolio and throughout all clinical stages of development. The incumbent will directly manage the transition of drug substance and drug product development to GMP manufacturing including transitions between vendors ensuring that CDMO partners have the appropriate capabilities, facilities, and equipment necessary to ensure robust manufacturing processes that meet global regulations. The incumbent is responsible for developing and executing strategies in collaboration with product development and CDMO partners that optimize manufacturing processes, costs, product performance, and continuous improvement. The incumbent is responsible for managing DS development scientists and manufacturing partners as well as developing strong partnerships with cross-functional teams to establish and maintain product process timelines and strategies.

Responsibilities:

• Independently and strategically develop and lead the DS development team. Closely collaborate with DP development team. Build strong GMP manufacturing partnerships with the appropriate capabilities to support drug development and GMP manufacturing throughout the clinical phases of development and commercialization.
• Develop the group structure and the on-boarding of key personnel to accentuate internal skills as well as close internal gaps in knowledge/talent while managing full-time personnel and contingent workers.
• Develop and meet functional goals to established timelines.
• Provide technical leadership and subject matter expertise throughout the various clinical phases of development, scale-up and commercialization of small molecule DS processes including DS manufacturing optimization. Collaborate with DP development team on DP process optimization and GMP manufacturing. Ensure DS and DP processes ultimately are efficient, robust and suitable for large-scale cGMP production, aligning process, validation, and supply approaches with overall program and portfolio objectives.
• Define and maintain the technical framework for DS process lifecycle management (e.g., process validation and ongoing verification, and process performance optimization) and collaborate on DP process lifecycle management to support reliable clinical and commercial supply; act as lifecycle technical owner for DS processes, including process/impurity control strategy, continued process improvement and verification (CPV), and technical input into change controls across clinical and commercial stages.
• Lead operational oversight of all DS technology transfer and process improvement activities and collaborate on all DP technology transfer and process improvement activities at CDMOs from early-stage clinical development through commercialization, including coordinating and reviewing technology transfers activities, reviewing and approving batch records, ensuring CDMO cGMP manufacturing readiness, overseeing production campaigns of key starting materials, DS, and DP in compliance with cGMP requirements, and providing timely resolution of technical, manufacturing performance and operational issues.
• Oversee early-phase development personnel through the transition of processes from Discovery to CMC. Support early-stage (pre-clinical through Phase 2a) development activities by providing late-stage and commercial manufacturing perspectives to Neumora CMC and program teams and external partners.
• Represent late-stage process strategy, validation and clinical/commercial manufacturing on internal Neumora cross-functional CMC and program teams, communicating risks, mitigation plans, and supply readiness for key program milestones.
• Lead technical investigations, deviations and root cause analyses at CDMOs, including assessing product impact and implementing corrective and preventive actions; represent Neumora in technical discussions during regulatory inspections and partner diligence activities as needed.
• Address challenges and conflict in real-time with a solution-oriented approach.
• Collaborate with Manufacturing Operations, Quality, Regulatory Affairs, and CDMOs on the review/appropriateness of MBRs, process transfers, process verification, cleaning verification, process validation, and specification development, investigations, changes, and risk assessments to ensure compliance with cGMP and health authority expectations.
• Oversee, prepare and/or review CMC sections of regulatory submissions (e.g., IND, CTA, NDA), including process description, control strategy, validation, and lifecycle management documentation.
• Contribute to establishing best practices ways of working with CDMOs, including technical input into CDMO selection, technical due diligence, and continuous improvement of external collaborations.
• Develop and maintain a phase appropriate QMS for PD and Manufacturing as appropriate.
• Support CDMO audits and quality agreements within the scope of the role.
• Serve as the Program Team Lead (core team and sub team as needed) lead on Neumora internal and external facing programs.

Qualifications:

• S./M.S. or Ph.D. in Chemical Engineering or a closely related engineering or scientific discipline.
• Minimum of 15 years of pharmaceutical industry experience with substantial focus on small molecule drug substance process strategy and validation, scale-up, and late-phase cGMP manufacturing operations.
• Demonstrated experience with late-stage (Phase 2b–3) and commercial drug substance cGMP manufacturing, including successful technology transfers and process validation at CDMOs or external manufacturing sites.
• Strong working knowledge of cGMP requirements and CMC regulatory expectations (FDA, EMA, ICH) for small molecule DS, including prior involvement in authoring or reviewing CMC sections of major regulatory submissions.
• Comfortable using design of experiments (DoE), JMP, process capability analysis, and other statistical tools (directly or via specialists) to drive process characterization and validation.
• Proven ability to work effectively with cross-functional teams (e.g., CMC, Quality, Regulatory, Supply Chain, Program Management) and external partners to deliver clinical and commercial supply.
• Excellent communication, problem-solving, and organizational skills, with a track record of influencing decisions and driving execution in a fast-paced, development-stage environment.
• Available to travel for man in plant and technical visits at least 20%.

Preferred Qualifications:

• Experience in small molecule pharmaceutical development for solid oral dosage forms.
• Significant work experience in a virtual (100% outsourced) biopharmaceutical development business model is preferred.