Eli Lilly and Company
Sr. Director, ADC Drug-Linker Synthetic Process Development
Eli Lilly and Company, Indianapolis, Indiana, us, 46262
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana, committed to developing and delivering life‐changing medicines, improving disease understanding and management, and supporting communities through philanthropy and volunteerism.
Responsibilities
Lead and oversee CMC process development activities for novel payloads and drug‑linkers within ADC programs, ensuring alignment with overall program goals.
Collaborate closely with Discovery teams to ensure manufacturability and facilitate smooth transition from early research to CMC development.
Develop scalable, robust, and reproducible processes for payload linker synthesis, enabling technology transfer from development labs to GMP manufacturing.
Build and strengthen internal capabilities by developing team expertise, infrastructure, and technologies related to payload linker process development.
Stay current on emerging technologies and scientific advancements in ADC linker and payload chemistry to maintain a competitive edge.
Champion a strong safety culture in all laboratory activities, ensuring proper handling, containment, and risk assessment practices for highly potent compounds.
Provide technical guidance and career development support to team members, including goal setting, performance evaluations, and skills enhancement.
Manage external collaborations with vendors and CDMOs specializing in linker and payload synthesis and process development.
Ensure compliance with regulatory guidelines and support filing activities for INDs, BLAs, and other regulatory submissions.
Basic Requirements
Ph.D. in synthetic organic chemistry or a relevant scientific discipline with >8 years of experience; or B.S. or M.S. with 15+ years of demonstrated equivalent experience in a related field.
Proven leadership experience managing small‑molecule CMC development programs and leading scientific teams through all stages of development from discovery handoff to GMP manufacturing and regulatory submission.
Extensive expertise and scientific knowledge in linker design, payload chemistry, and related bioconjugation strategies.
Proven ability to drive innovation in ADC or small‑molecule process development, focusing on implementing novel technologies, improving efficiency, and solving complex scientific challenges.
Experience in preparing and contributing to regulatory filings, including IND, IMPD, and BLA submissions, with responsibility for drafting and reviewing CMC‑related documentation.
Additional Skills/Preferences
Experience working in high‑potency laboratory environments, including containment strategy development and occupational safety practice implementation.
Experience working with ADC projects, particularly regarding unique CMC and regulatory considerations, is a plus.
Strong leadership skills with a track record of building, mentoring, and retaining high‑performing technical teams.
Excellent cross‑functional collaboration and communication skills; able to influence without authority and align internal and external stakeholders.
Physical Demands/Travel The physical demands of this job are consistent with a laboratory and office environment.
Work Environment This position’s work environment is primarily laboratory and office. The requirements and expectations described here are representative of those encountered while performing the essential functions of this job.
Accommodations Lilly is dedicated to helping individuals with disabilities actively engage in the workforce, ensuring equal opportunities. If you require accommodation to submit a resume or interview for this position, please submit a request online. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.
EEO Statement Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
Compensation and Benefits Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $159,000 – $233,200. Full‑time equivalent employees may also be eligible for a company bonus (depending on performance). Lilly offers a comprehensive benefit program, including 401(k) matching, pension, vacation, medical/dental/vision/pharmacy benefits, flexible benefits such as healthcare and dependent day care flex spending accounts, life insurance, death benefits, time‑off and leave of absence options, and well‑being benefits such as an employee assistance program, fitness programs, and employee clubs. Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs at its discretion; Lilly’s compensation practices and guidelines will apply for any promotion or transfer.
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Responsibilities
Lead and oversee CMC process development activities for novel payloads and drug‑linkers within ADC programs, ensuring alignment with overall program goals.
Collaborate closely with Discovery teams to ensure manufacturability and facilitate smooth transition from early research to CMC development.
Develop scalable, robust, and reproducible processes for payload linker synthesis, enabling technology transfer from development labs to GMP manufacturing.
Build and strengthen internal capabilities by developing team expertise, infrastructure, and technologies related to payload linker process development.
Stay current on emerging technologies and scientific advancements in ADC linker and payload chemistry to maintain a competitive edge.
Champion a strong safety culture in all laboratory activities, ensuring proper handling, containment, and risk assessment practices for highly potent compounds.
Provide technical guidance and career development support to team members, including goal setting, performance evaluations, and skills enhancement.
Manage external collaborations with vendors and CDMOs specializing in linker and payload synthesis and process development.
Ensure compliance with regulatory guidelines and support filing activities for INDs, BLAs, and other regulatory submissions.
Basic Requirements
Ph.D. in synthetic organic chemistry or a relevant scientific discipline with >8 years of experience; or B.S. or M.S. with 15+ years of demonstrated equivalent experience in a related field.
Proven leadership experience managing small‑molecule CMC development programs and leading scientific teams through all stages of development from discovery handoff to GMP manufacturing and regulatory submission.
Extensive expertise and scientific knowledge in linker design, payload chemistry, and related bioconjugation strategies.
Proven ability to drive innovation in ADC or small‑molecule process development, focusing on implementing novel technologies, improving efficiency, and solving complex scientific challenges.
Experience in preparing and contributing to regulatory filings, including IND, IMPD, and BLA submissions, with responsibility for drafting and reviewing CMC‑related documentation.
Additional Skills/Preferences
Experience working in high‑potency laboratory environments, including containment strategy development and occupational safety practice implementation.
Experience working with ADC projects, particularly regarding unique CMC and regulatory considerations, is a plus.
Strong leadership skills with a track record of building, mentoring, and retaining high‑performing technical teams.
Excellent cross‑functional collaboration and communication skills; able to influence without authority and align internal and external stakeholders.
Physical Demands/Travel The physical demands of this job are consistent with a laboratory and office environment.
Work Environment This position’s work environment is primarily laboratory and office. The requirements and expectations described here are representative of those encountered while performing the essential functions of this job.
Accommodations Lilly is dedicated to helping individuals with disabilities actively engage in the workforce, ensuring equal opportunities. If you require accommodation to submit a resume or interview for this position, please submit a request online. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.
EEO Statement Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
Compensation and Benefits Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $159,000 – $233,200. Full‑time equivalent employees may also be eligible for a company bonus (depending on performance). Lilly offers a comprehensive benefit program, including 401(k) matching, pension, vacation, medical/dental/vision/pharmacy benefits, flexible benefits such as healthcare and dependent day care flex spending accounts, life insurance, death benefits, time‑off and leave of absence options, and well‑being benefits such as an employee assistance program, fitness programs, and employee clubs. Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs at its discretion; Lilly’s compensation practices and guidelines will apply for any promotion or transfer.
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