Advisor - Local Site Technical Services Molecule Steward - Small Molecule

BioSpace; Lebanon (IN); On-site; USD 140,000 - 230,000; Full time

Job summary

A leading pharmaceutical company is seeking an Advisor for Local Site Technical Services to provide technical oversight for the Lebanon facility's API manufacturing. This role requires a Bachelor's degree in Chemistry, Engineering, or a related field, along with over 10 years of experience in cGMP API manufacturing. Responsibilities include facilitating process knowledge transfer, collaborating on facility start-ups, and authoring standard operating procedures. Strong technical leadership and communication skills are essential.

Qualifications

• Minimum of 10 years of direct experience in cGMP API manufacturing.
• Experience covering multiple unit operations related to API development.
• Understanding of process and cleaning validations, commercialization strategies.

Responsibilities

• Provide technical oversight for molecules manufactured at the Lebanon facility.
• Lead technical transfer of processes between production facilities.
• Facilitate process knowledge transfer to Process Team members.
• Collaborate with Manufacturing to support facility start-up and qualification.
• Author, review, or approve standard operating procedures related to TS/MS activities.
• Lead investigations and technical studies, and support process validation activities.
• Drive continuous improvements and post‑launch technical agendas.
• Interact with regulators and support agency audits as needed.
• Ensure compliance with quality, safety and regulatory expectations (cGMP).

Skills

Technical leadership

Communication skills

Analytical skills

Problem-solving skills

Prioritization

Collaboration

Education

Bachelor’s degree in Chemistry, Engineering, Pharmaceutical Sciences or related field

Job description

Advisor - Local Site Technical Services Molecule Steward - Small Molecule

At Lilly, we unite caring with discovery to make life better for people around the world. This role serves as the technical representative for the Lebanon facility. The position collaborates with central TSMS teams and other manufacturing sites to ensure robust molecule stewardship, seamless transfer of API from pre‑commercial to commercial stages, and commercialization support for new molecules.

Responsibilities

• Provide technical oversight and stewardship for one or more molecules manufactured at the Lebanon facility. Lead technical transfer of processes between production facilities. Anticipate and address complex scale‑up issues.
• Facilitate process knowledge transfer to Process Team members and assist in process‑related training for Manufacturing Process Team members.
• Collaborate with Manufacturing to support the start‑up and qualification of new facilities and associated process equipment.
• Author, review, or approve standard operating procedures related to TS/MS activities. Review and approve manufacturing batch records and other documentation.
• Authorize technical documents supporting process control strategies, technology transfers, process validation, deviation/adverse event reporting, and technical studies.
• Lead resolution of technical issues related to control strategy and manufacturing.
• Anticipate and resolve key technical or operational problems, communicating issues promptly and leading process‑related investigations.
• Mentor and provide scientific expertise to Process Team members; apply process knowledge and data analysis skills to support API manufacturing operations.
• Design laboratory experiments to guide process troubleshooting and continuous process improvement. Implement medium to large continuous improvements to manufacturing processes.
• Lead post‑launch technical agendas and deliver projects that drive substantial step changes in manufacturing.
• Interact with regulators or stakeholders on technical issues or in support of internal and external agency audits.
• Lead or assist in planning and execution of process validation activities and large process‑related change controls.
• Make decisions that impact a function or geography, building relationships with internal and external partners.
• Perform all job responsibilities in compliance with quality, safety and regulatory expectations as well as cGMP.

Basic Requirements

• Education Level: Bachelor’s degree in Chemistry, Engineering, Pharmaceutical Sciences, or a related field (Chemistry focus preferred).
• Experience: Minimum of 10 years of direct experience in cGMP API manufacturing, covering multiple unit operations and platforms related to API development, commercialization, and commercial production.

Additional Skills/Preferences

• Strong technical leadership and communication skills.
• Advanced analytical and problem‑solving skills.
• Deep understanding of process and cleaning validations, commercialization strategies, and execution.
• Ability to integrate multiple technology disciplines to advance programs.
• Effective prioritization and multitasking capabilities.
• Collaborative mindset with cross‑functional teams.

Additional Information

• Position Location: US: Lebanon IN (LP1 site)
• Travel Percentage: 5‑30%
• Shift Information: 8‑hour shift, 5 days a week. Occasional night and weekend work may be required.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities for all. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form for further assistance.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.