Director, Raw Material Strategy and Drug Product Lead

BioSpace; Boston (MA); On-site; USD 158,000 - 275,000; Full time

Job summary

A leading company is seeking a proactive and scientifically grounded Director to lead the development of GMP cell banking and drug product processes. The role demands a cross-functional leader who can strategically integrate resources and drive the development of innovative therapies, ensuring compliance with regulatory standards.

Benefits

Comprehensive benefit program

401(k) and pension

Vacation benefits

Medical, dental, and vision benefits

Employee assistance program

Fitness benefits

Qualifications

• Minimum of 6+ years (Ph.D.) or 12+ years (M.S.) in industry.
• Experience in cell therapy, biologics, or regenerative medicine.
• Proven expertise in GMP cell banking, cryopreservation.

Responsibilities

• Establish and lead a unified technical strategy for cell banking and drug product development.
• Oversee lifecycle management of cell banks.
• Integrate automation technologies to enhance efficiency.

Skills

Leadership

Cell Therapy Expertise

GMP Compliance

Education

Ph.D. or M.S. in Cell Biology, Chemical Engineering, Bioengineering, Pharmaceutical Sciences

Job description

Director, Raw Material Strategy and Drug Product Lead

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Director, Raw Material Strategy and Drug Product Lead

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At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

Overview

At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.

Summary

We are looking for a proactive, scientifically grounded Director to lead the development and integration of GMP cell banking, cryopreserved drug product process development, and raw material/media strategy. This role is ideal for a technically strong, cross-functional leader who can operate strategically while also being hands-on. You will play a critical role in enabling our first-in-human studies, and in building the infrastructure to scale into future clinical phases.

Roles and Responsibilities

• Establish and lead a unified technical strategy that integrates GMP cell banking, cryopreserved drug product development, raw material control, and media optimization and production to support pre-clinical and clinical programs
• Oversee the development, qualification, and lifecycle management of iPSC Master and Working Cell Banks, ensuring traceability, testing compliance, and alignment with regulatory expectations.
• Drive the development and scale-up of cryopreserved iPSC derived cell therapy products, including optimization of freezing/thawing protocols, formulation buffers, container-closure systems, and post-thaw performance characterization.
• Lead the implementation of a robust raw material control framework, including sourcing, vendor selection, risk assessments, and change management—ensuring consistency across media, reagents, and critical inputs for development processes.
• Champion the integration of automation and high-throughput technologies where appropriate, to enable efficient and scalable execution across cell banking, media preparation, and formulation workflows.
• Collaborate cross-functionally with Quality, Regulatory, Analytical Development, and Manufacturing (CDMOs) to support CMC documentation, tech transfer, and regulatory submissions (e.g., IND, IMPD).
• Build, lead, and mentor a multidisciplinary team of scientists, engineers, and technical staff while fostering a culture of scientific rigor, operational excellence, and compliance.
  
  
  

Basic Requirements

• Ph.D. or M.S. in Cell Biology, Chemical Engineering, Bioengineering, Pharmaceutical Sciences, or a related discipline.
• Ph.D. 6+ years and M.S. 12+ years of industry experience, including leadership roles in cell therapy, biologics, or regenerative medicine.
  
  
  

Additional Preferences

• Proven expertise in at least two of the following: GMP cell banking, cryopreservation, media formulation and production, and raw material control.
• Experience supporting early clinical-stage programs and contributing to regulatory submissions.
• Strong understanding of GMP, ICH, and regulatory expectations for raw materials and cell therapy products.
  
  
  

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 Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.

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

$158,250 - $275,000

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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  Director

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