Director or Senior Director, CMC Program Management

Kymera Therapeutics; Massachusetts; On-site; USD 195,000 - 330,000; Full time

Benefits offered by this job

Competitive compensation

Annual bonus eligibility

Equity participation

Comprehensive benefits

Job summary

Kymera Therapeutics is a clinical-stage biotechnology company seeking a Sr. Director of CMC to lead end-to-end CMC program management for mid-to-late-stage programs, shaping timelines for drug substance, product, analytical, and regulatory workstreams in collaboration with CDMOs/CROs.

You will guide Phase 3 planning, technology transfer, and regulatory filings, build integrated plans, drive risk assessments, and mentor cross-functional teams to ensure on-time delivery of high-quality

Qualifications

• PhD, MS in pharmaceutics, pharmaceutical sciences, chemistry, chemical engineering, or related discipline with 10+ years (PhD) or 15+ years (MS) of CMC experience; Sr. Director level requires commensurate additional experience.
• CMC program/project management experience for oral small molecule programs, with experience advancing programs through Phase 3, NDA/MAA submission, process validation, and approval.
• Broad CMC knowledge spanning drug substance, product, and analytical development, with depth to challenge assumptions, assess risk, and support troubleshooting.
• Experience with CDMOs and CROs, technology transfer, GMP manufacturing, and commercial supply management.
• Knowledge of global CMC regulatory requirements (FDA, EMA, ICH), GMP/GLP, and inspection readiness.
• Proven ability to manage complex, cross-functional programs and translate technical concepts into executable plans.
• Exceptional communication, organizational skills and attention to detail.
• Proficiency with project management tools (MS Project, Smartsheet, or equivalent) for integrated timeline and resource planning.

Responsibilities

• Drive end-to-end CMC program management for mid to late-stage programs, including timeline development, critical path identification, risk assessment, and execution tracking.
• Build and maintain integrated plans spanning drug substance, drug product, analytical, quality, regulatory, and supply chain workstreams.
• Support planning and execution of Phase 3, registration and validation campaigns, commercial-scale technology transfer, and commercial readiness activities for oral solid dosage forms.
• Conduct CMC team meetings; ensure clear, timely communication of status, risks, decisions, and issues
• Participate in CDMO/CRO meetings to monitor status, action items, and risks, and ensure alignment with CMC plans. Proactively identify items that require action.
• Coordinate preparation, review, and on-time delivery of CMC components for global regulatory filings, in partnership with Regulatory Affairs and subject matter experts.
• Serve as the CMC timeline and deliverables go-to contact for CMC function leads, core team program managers, and cross-functional partners.
• Develop CMC best practices for decision-making and scenario planning.
• Promote a culture of cross-functional collaboration and execution excellence.

Skills

CMC program management

Phase 3 experience

Regulatory knowledge

Cross-functional leadership

Strong communication

Risk assessment

Analytical thinking

Project management tools

Education

PhD in pharmaceutics or related

MS in related field

Tools

MS Project

Smartsheet

Job description

Who we are

Kymera is a clinical-stage biotechnology company pioneering the field of targeted protein degradation (TPD) to develop medicines that address critical health problems and have the potential to dramatically improve patients’ lives. Kymera is deploying TPD to address disease targets and pathways inaccessible with conventional therapeutics. Having advanced the first degrader into the clinic for immunological diseases, Kymera is focused on building an industry-leading pipeline of oral small molecule degraders to provide a new generation of convenient, highly effective therapies for patients with these conditions. Founded in 2016, Kymera has been recognized as one of Boston’s top workplaces for the past several years. For more information about our science, pipeline and people, please visitwww.kymeratx.com or follow us onX (formerly Twitter)orLinkedIn.

Who we are

Kymera is a clinical-stage biotechnology company pioneering the field of targeted protein degradation (TPD) to develop medicines that address critical health problems and have the potential to dramatically improve patients’ lives. Kymera is deploying TPD to address disease targets and pathways inaccessible with conventional therapeutics. Having advanced the first degrader into the clinic for immunological diseases, Kymera is focused on building an industry-leading pipeline of oral small molecule degraders to provide a new generation of convenient, highly effective therapies for patients with these conditions. Founded in 2016, Kymera has been recognized as one of Boston’s top workplaces for the past several years. For more information about our science, pipeline and people, please visitwww.kymeratx.com or follow us onX (formerly Twitter)orLinkedIn.

How we work

• PIONEER: We are courageous, resilient and rigorous in our mission to improve patients’ lives through our revolutionary degrader medicines.
• COLLABORATE: We value trust + transparency from everyone. Our goals are shared, our decisions data-driven and our camaraderie genuine.
• BELONG: We recognize our differences, inviting curiosity and inclusivity, so that our people are valued, seen, and heard.

How you’ll make an impact

• Drive end-to-end CMC program management for mid to late-stage programs, including timeline development, critical path identification, risk assessment, and execution tracking.
• Build and maintain integrated plans spanning drug substance, drug product, analytical, quality, regulatory, and supply chain workstreams.
• Support planning and execution of Phase 3, registration and validation campaigns, commercial-scale technology transfer, and commercial readiness activities for oral solid dosage forms.
• Conduct CMC team meetings; ensure clear, timely communication of status, risks, decisions, and issues
• Participate in CDMO/CRO meetings to monitor status, action items, and risks, and ensure alignment with CMC plans. Proactively identify items that require action.
• Coordinate preparation, review, and on-time delivery of CMC components for global regulatory filings, in partnership with Regulatory Affairs and subject matter experts.
• Serve as the CMC timeline and deliverables go-to contact for CMC function leads, core team program managers, and cross-functional partners.
• Develop CMC best practices for decision-making and scenario planning.
• Promote a culture of cross-functional collaboration and execution excellence.

Skills and experience you’ll bring

• PhD., M.S., or equivalent in pharmaceutics, pharmaceutical sciences, chemistry, chemical engineering, or a related discipline, with 10+ years (Ph.D.) or 15+ years (M.S.) of CMC experience; Sr. Director level requires commensurate additional experience and demonstrated scope.
• CMC program/project management experience for oral small molecule programs, with experience advancing programs through Phase 3, NDA/MAA submission, process validation, and approval.
• Broad CMC technical knowledge spanning drug substance, drug product, and analytical development, with sufficient depth to challenge assumptions, assess risk, and support troubleshooting.
• Prior experience in working with CDMOs and CROs, technology transfer, GMP manufacturing, and commercial supply management.
• Working knowledge/experience in global CMC regulatory requirements and expectations (FDA, EMA, ICH), GMP/GLP compliance, and inspection readiness.
• Proven ability to manage complex, cross-functional programs and translate technical concepts into executable plans.
• Exceptional communication, organizational skills and attention to detail.
• Proficiency with project management tools (e.g., MS Project, Smartsheet, or equivalent) for integrated timeline and resource planning.

Equal Employment Opportunity

Kymera Therapeutics is proud to be an equal opportunity employer, seeking to create a welcoming and diverse environment. All applicants will receive consideration for employment without regard to race, color, religion, creed, gender, national origin, age, disability, veteran status, pregnancy, sex, marital status, gender expression or identity, genetic information, sexual orientation, citizenship, or any other legally protected class.

Compensation

• Kymera offers a competitive compensation package that recognizes both results and capabilities through market-based, performance-driven pay.
• The anticipated base salary range for this role is $195,000 – $330,000, with eligibility for annual bonus, equity participation, and comprehensive benefits.
• Actual salary is based on a holistic evaluation of the specific role/level as well as each candidate’s depth of experience and the capabilities they bring to the position.