Advisor - Technical Steward - TSMS

Job Overview

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Employment Type

Full-time
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Compensation

Salary
Range $66,000.00 - $209,000.00
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Work Schedule

On-call
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Benefits

Health Insurance
Dental Insurance
Vision Insurance
401(k)
pension
vacation benefits
Life insurance

Job Description

Lilly is a globally recognized pharmaceutical company headquartered in Indianapolis, Indiana, with over 50,000 employees worldwide dedicated to advancing health care through innovative and life-changing medicines. The company embodies a commitment to uniting caring with discovery to improve lives globally. At Lilly, every decision, every detail, and every day is driven by the urgent and selfless work required to meet the needs of patients who depend on their medicines. Lilly takes pride in delivering solutions that are impactful and meaningful, focusing on the critical mission of making life better for people everywhere. They foster a culture grounded in purpose, collaboration, and scientific excellence, providing employees with the opportunity to engage in work that genuinely matters to patients and communities.

Currently, Lilly is expanding its footprint with the construction of an advanced manufacturing facility in Houston, Texas, focused on the production of Active Pharmaceutical Ingredients (APIs) including novel modalities. This greenfield manufacturing site marks a significant investment in Lilly’s future and represents a unique opportunity to be part of a startup team tasked with developing and operationalizing processes to achieve successful Good Manufacturing Practice (GMP) commercial manufacturing. The role in this new facility is situated within the Technical Services and Manufacturing Sciences (TSMS) function and involves stewardship, site transfer, and commercialization support for small molecule, peptide, or oligonucleotide molecules.

This position requires a seasoned professional with comprehensive knowledge of the pharmaceutical industry and GMP regulatory expectations for large-scale manufacturing. The successful candidate will leverage their scientific expertise and leadership to oversee the technical transfer and process operations, collaborating across multiple departments including engineering, validation, quality assurance, quality control, development, and regulatory compliance. They will provide mentorship to process teams, troubleshoot complex technical manufacturing issues, author detailed technical reports, and lead continuous improvement and validation activities. This challenging yet rewarding role demands a proactive approach to problem-solving, strong communication skills, and the ability to influence across functional and geographic boundaries.

In addition to the technical responsibilities, the role involves supporting the startup and validation of new process equipment and facilities, managing change controls of varying complexity, and ensuring compliance with safety and GMP standards. The candidate is expected to make decisions that impact broader functional areas and build strong internal and external partnerships. This full-time role requires occasional travel, on-site presence, participation in shift work, and being on call to support manufacturing needs. Lilly values diversity and inclusion, actively supports employees with disabilities, and promotes an egalitarian and supportive work environment through its employee resource groups. The compensation for this position ranges broadly from $66,000 to $209,000 annually, depending on experience, education, and location, complemented by a company bonus structure and a comprehensive benefits package that includes medical, dental, vision, life insurance, 401(k), pension, vacation, flexible spending accounts, and wellness programs. Full compliance with US work authorization requirements is mandatory for this employment opportunity.

Job Requirements

  • At least 10 years of experience in cGMP small molecule, peptide, or oligonucleotide API commercial-scale manufacturing
  • Bachelor’s degree required, master’s or PhD preferred
  • Process and equipment knowledge of chemical synthesis active pharmaceutical ingredients
  • Thorough understanding of GMP requirements for large-scale manufacturing facilities
  • Demonstrated leadership skills
  • Excellent oral and written communication skills
  • Must be authorized to work in the United States on a full-time basis without sponsorship
  • Willingness to work onsite and occasional travel
  • Ability to work shifts and be on call as needed

Job Qualifications

  • Bachelor’s degree in relevant scientific or engineering discipline required
  • Master’s or PhD degree preferred
  • Minimum 10 years of experience in cGMP small molecule, peptide, or oligonucleotide API commercial-scale manufacturing
  • Proven leadership skills
  • Excellent oral and written communication skills
  • Strong process and equipment knowledge of chemical synthesis of APIs
  • Thorough understanding of GMP requirements in large-scale manufacturing
  • Demonstrated ability to lead technical and manufacturing agendas
  • Experience with process validation and commercialization is a plus
  • Ability to work onsite full-time and occasional travel
  • Authorization to work in the United States without sponsorship

Job Duties

  • Provide technical oversight and stewardship for molecules manufactured at the Houston facility
  • Lead technical transfer of processes between production sites, addressing complex scale-up issues
  • Mentor Process Team members in monitoring, trending, and analyzing production data
  • Author technical reports supporting process control strategies, technology transfers, process validation, deviation and adverse event reporting, and technical studies
  • Lead resolution of technical issues related to control strategy and manufacturing
  • Troubleshoot manufacturing floor issues and lead process-related investigations with impact assessment
  • Write and review standard operating procedures and manufacturing documentation
  • Support process knowledge transfer and training for Manufacturing staff
  • Design and coordinate laboratory experiments for troubleshooting and continuous improvement
  • Assist in start-up and validation of new facilities and process equipment
  • Lead post-launch technical projects driving manufacturing improvements
  • Plan and execute process validation activities
  • Implement medium to large process-related change controls
  • Make impactful decisions and build relationships with internal and external partners
  • Perform all job responsibilities in compliance with safety, regulatory, and current GMP requirements

Job Criteria

Experience

Mid Level (3-7 years)


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