Kymera Therapeutics · 19 hours ago
Director, Process Engineering
Greater Boston
Full-time
Onsite
Director/Executive
$195K/yr - $275K/yr
15+ years expKymera Therapeutics is a clinical-stage biotechnology company pioneering the field of targeted protein degradation. They are seeking a highly motivated and experienced Director of Process Engineering to provide strategic and technical leadership in small-molecule drug substance process development, scale-up, and commercial readiness for therapies aimed at serious Immunology and Inflammation diseases.
BiotechnologyHealth CareMedicalTherapeutics
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
Qualification
Required
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
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
Preferred
Preference for candidates with a deep understanding of the principles of crystallization development and experience translating these to robust, scalable processes
Benefits
Annual bonus
Equity participation
Comprehensive benefits
Company
Kymera Therapeutics
Kymera Therapeutics is a biotechnology company that specializes in the field of targeted protein degradation.
51-200 employees
H1B Sponsorship
Kymera Therapeutics has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (5)
2024 (2)
2023 (4)
2022 (3)
2021 (3)
Funding
Current Stage
Public CompanyTotal Funding
$1.96BKey Investors
Biotechnology Value FundAtlas Venture
2025-12-10Post Ipo Equity· $602M
2025-06-26Post Ipo Equity· $250.8M
2024-08-19Post Ipo Equity· $225M
Leadership Team
Nello Mainolfi
Founder, President and Chief Executive Officer
Jeremy Chadwick
Chief Operating Officer
Recent News
2025-12-11
Company data provided by crunchbase