Associate Director - TSMS (Oligonucleotides)
Eli Lilly and Company
5 hours ago
On-site
Houston, TX
Operations
Main Purpose and Objectives:
- Lead/mentor a technical staff and understand chemical synthesis processing related to cGMP API commercial manufacturing.
- Manage routine production support activities while balancing technical projects and process optimizations.
- Support technical transfer of new processes to site; develop and execute process and process-related validation plans; establish process control and capability; maintain GMP compliance in associated documents/activities.
Responsibilities:
- Maintain a safe work environment; lead safety initiatives and support all HSE Corporate and Site Goals.
- Hire, manage, and grow a team of scientists supporting technology transfer, process validation, manufacturing operations, and continuous improvement; accountable for TSMS production support performance.
- Partner within TSMS and across disciplines to implement the technical agenda, site business plan objectives, and GMP Quality Plan objectives.
- Provide oversight and technical excellence for investigations and complaints.
- Perform technical review/approval of site quality documents, plans, regulatory submissions, validation-related documents, and studies.
- Interact with regulators, customers, and other outside stakeholders; support internal/external agency audits.
- Set strategic direction/technical agenda to improve process capability, process control, yield, and/or productivity.
- Network globally to share best practices, rationale, and control strategies for alignment across sites.
Basic Requirements:
- Bachelor’s or Master’s in Chemistry, Microbiology, Biochemistry, Biochemical Engineering, or related science.
- 5+ years of cGMP commercial API manufacturing experience in Technical Services or related disciplines (Manufacturing, QC, QA, Advanced Project Management, Development, Regulatory Sciences, or Engineering).
Additional Preferences:
- Experience in small molecule, peptide, or oligonucleotide manufacturing.
- Technical leadership, administrative, and organizational skills.
- Ability to deliver highly complex and cross-functional work.
- Demonstrated project management skills.
- Strong analytical/quantitative problem-solving.
- Ability to communicate and influence across stakeholders.
- Strategic thinking and ability to balance short- and long-term needs.
- Ability to learn and apply technical/scientific knowledge.
Other Information:
- Occasional travel (5–10%).
- Required to be working onsite; required to be on call; shift work may apply.
Benefits:
- Eligibility to participate in company-sponsored 401(k); pension; vacation benefits; medical, dental, vision, and prescription drug benefits; flexible benefits (e.g., healthcare/dependent day care FSA); life insurance and death benefits; time off/leave of absence benefits; well-being benefits (e.g., employee assistance program, fitness benefits).
Application Instructions:
- If you require accommodation to submit a resume, complete the workplace accommodation request form: https://careers.lilly.com/us/en/workplace-accommodation
- Lead/mentor a technical staff and understand chemical synthesis processing related to cGMP API commercial manufacturing.
- Manage routine production support activities while balancing technical projects and process optimizations.
- Support technical transfer of new processes to site; develop and execute process and process-related validation plans; establish process control and capability; maintain GMP compliance in associated documents/activities.
Responsibilities:
- Maintain a safe work environment; lead safety initiatives and support all HSE Corporate and Site Goals.
- Hire, manage, and grow a team of scientists supporting technology transfer, process validation, manufacturing operations, and continuous improvement; accountable for TSMS production support performance.
- Partner within TSMS and across disciplines to implement the technical agenda, site business plan objectives, and GMP Quality Plan objectives.
- Provide oversight and technical excellence for investigations and complaints.
- Perform technical review/approval of site quality documents, plans, regulatory submissions, validation-related documents, and studies.
- Interact with regulators, customers, and other outside stakeholders; support internal/external agency audits.
- Set strategic direction/technical agenda to improve process capability, process control, yield, and/or productivity.
- Network globally to share best practices, rationale, and control strategies for alignment across sites.
Basic Requirements:
- Bachelor’s or Master’s in Chemistry, Microbiology, Biochemistry, Biochemical Engineering, or related science.
- 5+ years of cGMP commercial API manufacturing experience in Technical Services or related disciplines (Manufacturing, QC, QA, Advanced Project Management, Development, Regulatory Sciences, or Engineering).
Additional Preferences:
- Experience in small molecule, peptide, or oligonucleotide manufacturing.
- Technical leadership, administrative, and organizational skills.
- Ability to deliver highly complex and cross-functional work.
- Demonstrated project management skills.
- Strong analytical/quantitative problem-solving.
- Ability to communicate and influence across stakeholders.
- Strategic thinking and ability to balance short- and long-term needs.
- Ability to learn and apply technical/scientific knowledge.
Other Information:
- Occasional travel (5–10%).
- Required to be working onsite; required to be on call; shift work may apply.
Benefits:
- Eligibility to participate in company-sponsored 401(k); pension; vacation benefits; medical, dental, vision, and prescription drug benefits; flexible benefits (e.g., healthcare/dependent day care FSA); life insurance and death benefits; time off/leave of absence benefits; well-being benefits (e.g., employee assistance program, fitness benefits).
Application Instructions:
- If you require accommodation to submit a resume, complete the workplace accommodation request form: https://careers.lilly.com/us/en/workplace-accommodation