SVP/VP - Technical Process Development, Biotech/Pharma

The SVP/VP, Technical Process Development is responsible for leading the execution of comprehensive, compound-specific development strategies to meet global R&D project needs from Phase I through Commercialization, and acts as a lead for the interface between Discovery and CMC.

This role provides technical leadership to interdisciplinary, matrix teams responsible for developing and executing technical development plans that incorporate all elements across the drug substance, drug product, analytical, quality, regulatory, and clinical/commercial supply, including acting as primary contact for core program teams for all things related to process development. The incumbent must provide hands-on leadership and be willing and able to support all aspects of development.

Responsibilities:

• Leads the DS/DP process development team including building out the team as needed to ensure strong development skills exist across various assets in development.
• Provides 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).
• Troubleshoots technical development and manufacturing challenges at the vendor (e.g., process development challenges, manufacturing issues and investigations) in collaboration with internal stakeholders.
• Leads end-to-end technology process transfers to and from vendors and business partners.
• Manages 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 collaborates with other functional areas (Clinical, Commercial, Regulatory, Clinical Pharmacology, Toxicology, Quality, etc.) to achieve the best development and business results for the company.
• Communicates and partners 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.
• Identifies and escalates key issues and risks as well as resource allocation needs, as appropriate.
• Critically reviews relevant documents, including development reports, technical documents, CMC regulatory submissions, briefing booklets, information requests, etc.
• Leads or contributes to continuous improvement initiatives across the enterprise.
• Partners 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.

Qualifications:

• 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.
• Commercial readiness and launch experience desirable.
• 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.

2025 Company benefits include:

• 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

The salary range posted describes the minimum to maximum base salary range for this position in the location listed.  Actual salary may vary based upon geographic location, work experience, education, licensure requirements and/or skill level and will be finalized at the time of offer. Base Salary Range: $328,617-$390,400