Associate Director, Drug Product CMC

Initial Therapeutics, Inc.; Indianapolis (IN); On-site; USD 129,000 - 231,000; Full time

Job summary

Lilly, headquartered in Indianapolis, IN, seeks an Associate Director, Drug Product within the CMC group to lead nonclinical and clinical formulation development for small molecules, manage external partners, and ensure timely deliverables across Phase I–III programs.

You will oversee cross-functional teams, coordinate vendor activities domestically and internationally, and contribute to regulatory submissions while travel of 5–10% is anticipated.

Qualifications

• BS or MS in Pharmaceutical Sciences or a related scientific discipline required; PhD strongly preferred.
• 7+ years of experience in small molecule formulation development across oral, subcutaneous, and intravenous dosage forms.
• Deep understanding of formulation development and manufacturing for poorly soluble (BCS II/IV) small molecules.
• Strong knowledge of pharmaceutical and engineering principles for liquid and solid dosage forms at clinical and commercial scale.
• Proficiency with analytical and solid-state characterization techniques (HPLC/UPLC, XRPD, DSC, TGA, DVS).
• Experience managing external development partners (CROs, CDMOs, CMOs).
• Working knowledge of cGMP requirements and pharmaceutical development standards.
• Strong strategic, analytical, and problem-solving skills; ability to drive timely results.
• Excellent communication, interpersonal, and project leadership skills.

Responsibilities

• Manage external vendors (CROs/CDMOs) to execute studies and development activities.
• Design and develop nonclinical formulations for oral, subcutaneous, and IV delivery.
• Oversee stability and compatibility studies for nonclinical formulations.
• Support clinical formulation development of oral solid dosage forms.
• Author or review development and dose preparation protocols and reports.
• Review PK/PD and safety study data related to formulations.
• Represent CMC in cross-functional teams for development guidance.
• Coordinate shipments to CDMO/CRO sites for clinical supply.
• Prepare formulation documentation for regulatory submissions (IND/CTA).
• Collaborate with discovery, nonclinical, clinical, PM, legal, sourcing, supply chain and QA/regulatory teams.

Skills

7+ years experience

Formulation development

Analytical techniques

cGMP knowledge

Vendor management

Cross-functional collaboration

Project leadership

Communication

Travel willingness

Education

BS/MS in Pharmaceutical Sciences

PhD preferred

Tools

HPLC/UPLC

XRPD

DSC

TGA

DVS

Job description

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

Centessa Pharmaceuticals, a wholly subsidiary of Eli Lilly and Company is advancing a portfolio of high conviction programs with strong biological validation. Our asset-centric model offers a unique R&D logic that has been applied by single asset companies to improve productivity. This operating model has minimal centralized infrastructure, reduced hierarchy, and exclusive focus on data driven capital allocation.

Our teams are uniquely incentivized to expeditiously interrogate key scientific hypotheses. We believe the asset-centric model can lead to improved success rates for programs with greater speed and modest costs.

Centessa’s CMC group is currently seeking an Associate Director of Drug Product within the CMC group to support our early stage programs. The successful candidate will have a demonstrated track record of designing high performance nonclinical and clinical formulations as well as managing CROs and CDMOs. The candidate should also have hands‑on experience in developing and manufacturing nonclinical and clinical small molecule drug products to support Phase I to Phase III. This candidate will primarily lead work with various vendors and oversee nonclinical formulation development, with flexibility to support clinical drug product development, across programs to meet company deliverables and timelines. Travel to vendors both domestically and internationally might occasionally be required.

Responsibilities:

• Manage and guide external vendors, such as Contract Research Organizations (CROs) and Contract Development and Manufacturing Organizations (CDMOs) to:
• Execute physiochemical characterization and pre-formulation studies for New Chemical Entities (NCEs).
• Design and develop nonclinical formulations of drug candidates (oral, subcutaneous, and intravenous) to ensure stability, bioavailability and effective drug delivery in animal models.
• Design and oversee execution of nonclinical formulation stability and compatibility studies.
• Support clinical formulation development of oral solid dosage forms, as needed.
• Author and/or review and approve development and dose preparation protocols and reports.
• Review formulation related sections of protocols and reports associated with Pharmacokinetic (PK), Pharmacodynamic (PD), and safety studies.
• Represent CMC and provide nonclinical formulation, DS and DP stability, and supply guidance at internal and external cross functional team meetings.
• Coordinate shipments in support of nonclinical and Clinical development supply requirements to various CDMO and CRO sites.
• Assist in compiling formulation-related documentation for regulatory submissions (e.g., IND, CTA) to meet nonclinical development requirements.
• Work closely and collaboratively with cross-functional CMC groups including discovery, nonclinical, clinical, project management, legal, sourcing, supply chain, quality and regulatory, as well as other CMC functions.

Minimum Qualifications:

• BS or MS in Pharmaceutical Sciences or a related scientific discipline required; PhD strongly preferred.
• 7+ years of experience in small molecule formulation development, including support of nonclinical and clinical programs across oral, subcutaneous, and intravenous dosage forms.
• Deep understanding of formulation development and manufacturing of poorly soluble (BCS Class II/IV) small molecule compounds for oral, subcutaneous, and intravenous delivery.
• Strong knowledge of pharmaceutical and engineering principles related to liquid and solid dosage form development at clinical and commercial scale.
• Proficiency with analytical and solid-state characterization techniques, including HPLC/UPLC, XRPD, DSC, TGA, DVS, and related methodologies.
• Experience managing external development partners (CROs, CDMOs, CMOs) and coordinating pharmaceutical product development activities.
• Working knowledge of cGMP requirements and pharmaceutical development standards.
• Strong strategic, analytical, and problem-solving skills, with the ability to anticipate risks, develop contingency plans, and drive timely, high-quality results.
• Excellent communication, interpersonal, and project leadership skills, with the ability to influence stakeholders, manage cross-functional and external relationships, and effectively communicate complex concepts to diverse audiences.
• Highly organized, detail-oriented, and self-directed, with the ability to manage multiple priorities and perform effectively in a fast-paced, dynamic environment; willingness to travel domestically and internationally (5-10%).

Work Location:

• The Associate Director, Drug Product, CMCrole is a based in the US, with occasional travel.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form https://careers.lilly.com/us/en/workplace-accommodation for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

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.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL).

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $129,000 - $231,000

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities). Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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