Senior Advisor, Manufacturing Science and Technology

Eli Lilly and Company; Watertown (MA); On-site; USD 141,000 - 228,800; Full time

Benefits offered by this job

401(k) participation

Comprehensive benefits program

Company bonus eligibility

Job summary

Eli Lilly and Company seeks a Senior Advisor, Manufacturing Science and Technology in Watertown, MA. You'll manage external manufacturing activities for proprietary lipid manufacturing while working closely with suppliers and internal teams.

The ideal candidate has a PhD or equivalent and at least 6 years of experience in biopharmaceutical manufacturing, particularly with lipid-based products. We offer comprehensive benefits and competitive salary.

Qualifications

• 6+ years experience with PhD, 9+ with Master's, or 12+ with Bachelor’s in relevant fields.
• 7+ years of manufacturing operations experience in biopharmaceuticals.
• Experience with lipid or excipient manufacturing and scale-up.

Responsibilities

• Manage external manufacturing activities for bespoke lipid manufacturing.
• Support drug substance and product manufacturing for clinical studies.
• Guide manufacturing strategy, goals, and operational activities.

Skills

Leadership skills

Problem-solving skills

Analytical skills

Regulatory knowledge

Cross-functional teamwork

Education

PhD, Master's, or Bachelor's in chemistry, life sciences, or engineering

Job description

Position Summary

We are seeking an exceptional Senior Advisor, Manufacturing Science and Technology to join Orna Therapeutics, a wholly‑owned subsidiary of Eli Lilly and Company in Watertown, MA. The candidate will manage external manufacturing activities for proprietary lipid manufacturing and pipeline support to circular RNA and lipid nanoparticle candidates. The role includes planning external manufacturing activities, ensuring timely delivery of materials, acting as the primary liaison with external suppliers, logistics providers, and test/manufacturing partners, and working with internal R&D, CMC, and other teams.

Responsibilities

• Technical and operational management of manufacturing operations for custom raw materials (lipids) through their development lifecycle.
• Support drug substance (DS) and drug product (DP) manufacturing for preclinical and clinical studies to enable seamless transition to commercial supply.
• Provide guidance and direction for manufacturing strategy, goals, budgets, and other operational activities to ensure timely delivery.
• Integrate internal and external team activities into manufacturing operations and present plans and progress to the Leadership Team as needed.
• Manage CDMOs for manufacturing operations, tech transfers, investigations/OOS, and batch documentation reviews.
• Identify and select CDMOs for cGMP manufacture for Orna’s portfolio development programs.
• Resolve any issues impacting timelines or other critical deliverables, communicate potential impacts to management and stakeholders, and assist in mitigation plans.
• Author regulatory and technical documents for regulatory submissions in support of custom raw materials (lipids) manufacturing and serve as subject‑matter expert in regulatory interactions.

Basic Requirements

• PhD, Master’s, or Bachelor’s degree in chemistry, life sciences, engineering, or related field with the following years of relevant industry experience: PhD 6+ years, Master’s 9+ years, or Bachelor’s 12+ years.
• Experience with lipid or excipient manufacturing and scale‑up is required.
• Minimum of 7+ years of manufacturing operations experience in the biopharmaceutical/pharmaceutical industry covering RNA/LNP modalities.
• Good understanding of tech transfer, cGMP manufacturing and regulatory requirements for RNA and LNP modalities.
• Experience working with cross‑functional product development teams, including R&D, QA, Pre‑clinical, Safety, Regulatory Affairs, and other groups.
• Experience authoring and reviewing early and/or late‑stage regulatory filings.

Additional Preferences

• Strong leadership skills, including demonstrated ability to influence at all levels of an organization.
• An entrepreneurial approach to develop new, innovative ideas that drive growth within the manufacturing organization.
• Effective relationship building with internal and external partners; availability to travel as needed.
• Ability to plan and implement stage‑appropriate change management and set realistic goals to ensure timely and successful completion.
• Strong analytical and problem‑solving skills with great attention to detail.
• Excellent oral and written communication skills, including presentation to effectively communicate key updates and challenges.
• Detail‑oriented, self‑motivated, and excited to take on new challenges.

Physical Demands / Travel

Work is performed in a lab environment. Travel is approximately 10% of the time.

Benefits and Compensation

Salary range: $141,000 - $228,800. Full‑time employees are eligible for a company bonus (depending on company and individual performance). Lilly offers a comprehensive benefits program, including 401(k) participation, pension, vacation, medical, dental, vision, prescription drug coverage, flexible spending accounts, life insurance, death benefits, leave of absence benefits, employee assistance program, fitness benefits, and employee clubs.

Equal Employment Opportunity Statement

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.