Director, Process Engineering

Role Summary

Director of Process Engineering to provide strategic and technical leadership in small-molecule drug substance process development, scale-up, and commercial readiness for potentially transformational therapies for serious Immunology and Inflammation diseases. Join a fast-paced, innovative biotech environment where bold ideas and collaboration drive breakthroughs. As a key member of the CMC organization, you will partner with process and analytical chemists to design robust, scalable, and cost-effective manufacturing processes that enable late-stage development, manufacturing and eventual commercialization. The ideal candidate will bring deep expertise in chemical process engineering within a GMP environment, strong project leadership capabilities, and a passion for delivering life-changing medicines.

Responsibilities

• Define and execute process engineering strategies aligned with Kymera’s timelines.
• Conduct design, development, optimization, and scale-up of small-molecule drug substance manufacturing processes using a unit operation approach.
• Drive process robustness, yield improvement, impurity control, and cost of goods optimization.
• Provide technical guidance for primarily outsourced development across various geographies.
• Co-lead registration stability, process characterization, and Process Performance Qualification (PPQ) activities.
• Co-author and review CMC sections of regulatory submissions (INDs, IMPDs, NDAs/MAAs), including process descriptions, control strategies, and validation approaches.
• Ensure processes are compliant with global regulatory expectations (FDA, EMA, ICH).
• Review and approve master and executed batch records. Assist with deviations, change controls, and other QA related tasks.
• Serve as the primary technical process engineering interface with C(D)MOs and external partners.
• Oversee and guide process development activities executed externally, ensuring timelines, quality, and technical rigor.
• Partner closely with Analytical Development, Drug Product Development, Quality, Regulatory Affairs, Supply Chain, and External CDMOs.
• Foster a culture of scientific excellence, accountability, and cross-functional collaboration.
• Implement best practices in process engineering, risk management, and data-driven decision-making.
• Identify and mitigate technical and operational risks from mid-stage development through commercialization.
• Contribute to long-range CMC planning, budgeting, and resource forecasting.

Qualifications

• Ph.D., M.S., or B.S. in Chemical Engineering.
• 15+ years of experience in small molecule pharmaceutical process engineering, with progressive technical and leadership responsibility.
• Demonstrated experience scaling small-molecule processes from theory to laboratory through commercial scale.
• Hands-on experience working with GMP manufacturing and CMOs.
• Strong understanding of chemical reaction engineering, unit operation modelling, crystallization, isolation, and purification processes.
• Experience with process modeling, scale-up principles, and technology transfer.
• Experience with process characterization- including Quality by Design (QbD) principles, process performance qualification (PPQ), and regulatory expectations for small molecules.
• Preference for candidates with a deep understanding of crystallization development and translating these to robust, scalable processes.
• Proven ability to lead manufacturing and development activities and influence cross-functional stakeholders.
• Excellent communication skills, with the ability to clearly convey complex technical concepts.
• Comfortable operating in a fast-moving, entrepreneurial biotech environment.

Education

• Ph.D., M.S., or B.S. in Chemical Engineering.