Technical Operations Manager, Process Chemistry
About The Position
The Technical Operations Manager, Process Chemistry, Kilo Lab provides leadership and oversight of Kilo Lab and Process Chemistry operational activities supporting process development, scale-up, technology transfer, clinical supply, and commercial development programs. The role leads Kilo Lab operations and ensures facilities, equipment, personnel, and operational systems are maintained and resourced for safe, efficient, and compliant process development activities and GMP campaigns. The position partners with Process Chemistry, Quality, Engineering, EHS, Manufacturing, and Project Management to support effective execution and project delivery. It sustains an agile, science-driven operating model that meets development-program needs while maintaining site safety, quality, and GMP compliance. Process Chemistry retains ownership of process design, technical direction, and operational procedures; Technical Operations provides infrastructure, resources, and execution support. The manager leads and develops Kilo Lab personnel, supports technology transfers and process scale-up, oversees process safety and equipment readiness, and helps plan operational capacity, staffing, facilities, equipment, budgets, and capability expansion.
Requirements
- BS, MS, or PhD in Chemical Engineering, Chemistry, Pharmaceutical Sciences, or a related technical discipline.
- 8+ years of experience in pharmaceutical, chemical, or CDMO operations.
- Experience supporting process development, scale-up, or pilot plant operations.
- Experience leading technical or operational teams.
- Demonstrated experience with GMP operations.
- Experience coordinating cross-functional activities.
- Knowledge of process safety and scale-up principles.
Nice To Haves
- Experience in API development and manufacturing.
- Technology transfer execution experience.
- Experience in early-phase pharmaceutical development.
- Experience with reactive chemistry and hazard assessment.
- Capital project management experience.
- Pharmaceutical pilot plant or Kilo Lab operations experience.
Responsibilities
- Lead Kilo Lab operations, including scheduling, resource allocation, equipment readiness, and execution of process development, scale-up, and GMP campaigns.
- Optimize facility utilization, operational efficiency, and execution across competing project priorities.
- Partner with Process Chemistry to enable process development, scale-up, and translation of laboratory procedures into safe, practical operations.
- Lead operational readiness for internal and external technology transfers, including resource assessments, scale-up readiness reviews, risk mitigation, and knowledge transfer.
- Collaborate on operational procedures and continuous improvement while preserving Process Chemistry ownership of process design and technical direction.
- Promote process safety through risk assessments, hazard reviews, and implementation of appropriate safeguards for development-scale operations.
- Oversee facility and equipment readiness, maintenance, reliability, qualification support, and lifecycle planning.
- Ensure compliance with site safety, quality systems, and GMP requirements, including personnel qualification, deviation management, CAPAs, and inspection readiness.
- Lead and develop Kilo Lab personnel, fostering a culture of safety, accountability, collaboration, and continuous improvement.
- Partner with Process Chemistry leadership to assess capacity, identify operational constraints, and plan future staffing, facility, and equipment needs.
- Support operating and capital budgets, capability expansion, and long-term capacity planning.
Benefits
- Comprehensive medical, dental, and vision insurance with significant employer contributions.
- 401(k) retirement plan with generous employer matching.
- Paid time off, paid sick leave, and company holidays.
- Employer-funded Health Savings Account contributions for eligible plans.
- Healthcare and dependent care Flexible Spending Accounts.
- Employer-paid employee life insurance, AD&D, and short- and long-term disability insurance.
- Employee Assistance Program, mental health resources, and wellness programs.
- Family-friendly benefits, including fertility support and maternity resources.
- Professional development and career growth opportunities.
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What This Job Offers
Job Type
Full-time
Career Level
Manager
