Senior Advisor, Regulatory Starting Material

Lilly • Indianapolis, IN

12d • $153,000 - $268,400

About The Position

Centessa Pharmaceuticals, a wholly owned subsidiary of Eli Lilly and Company, is seeking a Senior Advisor, Regulatory Starting Material for an Associate Director level role. The position leads the strategy, justification, and regulatory positioning of Regulatory Starting Materials (RSMs) for drug substance manufacturing processes supporting late-stage clinical and commercial programs. Reporting to the Vice President, CMC, the role serves as an internal and external subject matter expert on RSM selection under ICH Q11 and applicable regional guidance. It ensures synthetic routes, GMP starting points, and supply strategies are scientifically sound, regulatorily defensible, and aligned with commercial manufacturing readiness.

The Senior Advisor partners with Process Chemistry, Analytical Development, Regulatory Affairs, Quality, Supply Chain, Manufacturing, and external manufacturing partners to develop and defend RSM strategy in regulatory submissions and health authority interactions. The role also oversees starting material resupply and scale-up activities, supports technology transfer and manufacturing changes, manages relationships with API manufacturers and suppliers, and helps address risks affecting timelines, regulatory readiness, and commercial supply. Domestic and international travel of approximately 10–20% is required. The role is based in the US.

Requirements

• Advanced degree in chemistry, chemical engineering, or a related field; a PhD is strongly preferred.
• At least 7 years of relevant experience in CMC, process chemistry, or drug substance/API development and manufacturing, including demonstrated leadership of starting material or CMC regulatory strategy programs.
• Demonstrated experience supporting late-stage clinical and/or commercial drug substance programs.
• Deep working knowledge of ICH Q11 and applicable regional guidance and expectations governing the selection and justification of Regulatory Starting Materials.
• Demonstrated experience authoring and defending CMC regulatory submission content, including direct health authority interaction experience related to starting material or drug substance manufacturing strategy.
• Strong background in synthetic/process chemistry and ability to critically evaluate route scouting, impurity control strategy, and structural relevance arguments for candidate starting materials.
• Experience managing relationships with drug substance/API CMOs and raw material suppliers, including batch record reviews and overarching manufacturing oversight.
• Working knowledge of cGMP requirements for drug substance manufacturing and the GMP/non-GMP boundary.
• Strong leadership, cross-functional collaboration, and scientific writing and communication skills.
• Ability to exercise judgment within broadly defined practices and policies when determining solutions and actions.
• Demonstrated ability to identify and address starting material-related risks that could jeopardize regulatory timelines, supply, or overall program success.

Nice To Haves

• PhD in chemistry, chemical engineering, or a related field.
• Experience supporting technology transfer of drug substance processes from clinical to commercial scale.

Responsibilities

• Lead identification, justification, and regulatory strategy for Regulatory Starting Materials across drug substance synthetic routes in accordance with ICH Q11 and relevant regional guidance and reflection papers.
• Manage starting material resupply campaigns and scale-up efforts, including inventory, production forecasts, manufacturing timing, production suite slot reservations, and contracting.
• Author and review CMC regulatory submission content related to RSM selection and justification, including Module 3 sections, briefing documents, and agency responses, in support of INDs, NDAs, and MAAs.
• Prepare and lead health authority interactions related to starting material strategy, develop briefing packages, and represent the company in agency discussions.
• Partner with Process Chemistry and Analytical Development to evaluate synthetic routes, assess structural relevance of candidate starting materials, and support impurity fate-and-purge and risk assessments.
• Define and document the boundary between non-GMP and GMP manufacturing steps for drug substance processes, ensuring alignment with CMOs and internal quality standards.
• Lead technology transfer and process changes affecting RSM designation as programs move from late-stage clinical development toward commercial manufacturing.
• Manage relationships with drug substance/API CMOs and RSM suppliers, including technical oversight, site visits, supplier qualification, and dual-sourcing strategies.
• Monitor evolving global regulatory guidance and agency precedent on starting material selection and translate changes into updated internal strategy, templates, and risk assessments.
• Collaborate with Regulatory Affairs, Quality, Supply Chain, and Manufacturing to ensure RSM strategy supports program timelines, submission readiness, and commercial supply continuity.
• Support due diligence activities, including licensing and partnering, that require assessment of drug substance manufacturing routes and starting material risk.
• Provide subject matter expertise during regulatory inspections and audits related to drug substance manufacturing and starting material justification.
• Build, lead, and mentor a team supporting RSM and drug substance CMC strategy activities, depending on scope.

Benefits

• Company bonus, depending in part on company and individual performance.
• Eligibility to participate in a company-sponsored 401(k).
• Pension.
• Vacation benefits.
• Eligibility for medical, dental, vision, and prescription drug benefits.
• Flexible benefits, including healthcare and/or dependent day care flexible spending accounts.
• Life insurance and death benefits.
• Certain time off and leave of absence benefits.
• Well-being benefits, including an employee assistance program, fitness benefits, and employee clubs and activities.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior