Sr. Director - GMP Operations Project Management

BioSpace; Watertown (MA); On-site; USD 180,000 - 264,000; Full time

Benefits offered by this job

401(k) plan

Pension

Vacation benefits

Medical, dental, vision benefits

Flexible benefits

Well-being benefits

Job summary

Lilly seeks a GMP manufacturing project manager to lead cross-site, multi-CDMO programs, coordinating technology transfer, manufacturing readiness, materials, analytical testing, quality review, release, and delivery across internal sites and external partners.

The role demands senior program management in a cGMP environment, strong cross-functional collaboration with R&D, CMC, QA, Regulatory, and Supply Chain, and the ability to navigate complex dependencies with travel as needed.

Qualifications

• Experience managing external vendors (CDMOs, CROs, or suppliers) in biopharmaceuticals.
• Experience with sterile drug product manufacturing and fill-finish operations.
• Demonstrated ability to build and manage project timelines for multi-vendor, cross-functional programs.
• Proficiency in dashboards/reports using Smartsheet/Power BI/Tableau/Excel.

Responsibilities

• Serve as GMP PM lead for drug product manufacturing across CDMOs and Lilly sites.
• Develop and drive integrated project plans for tech transfer, manufacturing readiness, production, testing, release, and delivery.
• Coordinate cross-functional planning among CMC, Manufacturing, Quality, Regulatory, Supply Chain, and program teams.
• Establish milestones, dependencies, decision points, and owners across sites.
• Lead manufacturing readiness reviews and ensure timely closure of actions.
• Track GMP campaigns and communicate risks and impacts to teams and leadership.

Skills

Project management

Cross-functional leadership

Dashboards

Vendor management

Communication

Travel readiness

cGMP knowledge

Education

Bachelor’s degree in life sciences/chemistry/engineering/pharma

Master’s degree in life sciences/engineering/pharma

PhD in life sciences/engineering/pharma

Tools

Smartsheet

Power BI

Tableau

Excel

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.

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.

We are currently developing several novel drug delivery systems to serve our patients and make lives better. The Advanced Delivery Systems (ADS) portfolio includes gene editing, in vivo CAR T, and vaccine technologies. These programs span RNA, lipid nanoparticle (LNP), and cell and gene therapy modalities, and they advance through close collaboration among R&D, CMC, Quality, and Supply Chain teams and a network of external partners. This role is central to keeping that work on track by connecting vendors, internal teams, and leadership.

Position Summary

We are seeking an experienced GMP manufacturing project manager to lead integrated planning and execution of non-viral drug product manufacturing activities across multiple external CDMOs and Lilly internal manufacturing sites. This individual will develop and manage cross-functional GMP project plans encompassing technology transfer, manufacturing readiness, materials, production, analytical testing, quality review, release, and delivery. The role will connect internal technical and functional teams with manufacturing-site teams, identify dependencies and risks, facilitate timely decisions, and drive mitigation and recovery plans to support reliable delivery of GMP materials. The successful candidate will have strong experience managing complex manufacturing programs in a cGMP environment and working across CMC, Manufacturing, Quality, Supply Chain, Regulatory, and program teams.

Responsibilities

• Serve as the GMP project management lead for drug product manufacturing activities conducted across multiple CDMOs and Lilly internal manufacturing sites.
• Develop, maintain, and drive integrated project plans covering technology transfer, manufacturing readiness, production, analytical testing, quality review, release, and delivery.
• Coordinate cross-functional planning among CMC, Manufacturing, Quality, Supply Chain, Regulatory, and program teams.
• Establish clear milestones, dependencies, decision points, critical paths, and accountable owners across internal functions and manufacturing sites.
• Lead manufacturing readiness reviews to confirm alignment on materials, methods, documentation, equipment, scheduling, testing, and release activities.
• Facilitate recurring project-team and manufacturing-site meetings, document decisions and actions, and ensure timely closure of commitments.
• Identify schedule, technical, quality, supply, and resource risks that could affect GMP execution or material availability.
• Develop and drive mitigation, contingency, and recovery plans in partnership with the accountable technical and functional leads.
• Coordinate cross-site dependencies where drug substance, drug product, testing, packaging, release, or other activities occur at different locations.
• Track the status of GMP campaigns and communicate emerging risks, decisions, and impacts to program teams and leadership.
• Support escalation and resolution of issues affecting manufacturing execution while ensuring that technical and quality decisions remain with the accountable functions.
• Maintain portfolio-level visibility across concurrent GMP manufacturing projects and help prioritize activities when timelines or resources conflict.
• Establish fit-for-purpose project-management tools, templates, governance forums, and reporting practices for GMP manufacturing programs.
• Capture lessons learned from manufacturing campaigns and incorporate them into plans for subsequent batches, sites, and programs.
• Partner with the appropriate business functions on budget and contractual implications, without owning sourcing, contracting, or vendor onboarding.

Requirements

• Bachelor's, Master's, or PhD in life sciences, chemistry, engineering, or pharmaceutical sciences with the following years of CMC and project management experience: Bachelor's with 17+ years/Master's with 15+ years or PhD with 10+ years. Professional certifications, such as PMP or Six Sigma.
• Experience as a project manager managing external vendors (CDMOs, CROs, or suppliers) in the biopharmaceutical or pharmaceutical industry.
• Experience with sterile drug product manufacturing and fill-finish operations.
• Demonstrated experience building and managing project timelines for multi-vendor, cross-functional programs.
• Proficiency in building dashboards and reports using Smartsheet, Power BI, Tableau, or equivalent and advanced Excel.
• Working knowledge of cGMP manufacturing, tech transfer, and CMC development for RNA, LNP, or cell and gene therapy modalities.
• Experience working with cross-functional teams, including R&D, CMC, QA, Regulatory Affairs, Supply Chain, and Finance. Strong leadership skills, including the ability to influence and align cross-functional teams at all levels of an organization.
• Familiarity with project management tools and methodologies (PMP or equivalent a plus).
• Strong analytical and problem-solving skills, with great attention to detail and the ability to turn complex data into clear, actionable insights.
• Excellent oral and written communication skills, including presenting key updates and challenges to program and leadership teams.
• Entrepreneurial mindset with a drive to improve processes and bring structure to a fast-moving environment.
• Ability to build effective working relationships with internal and external partners. Available to travel if/when needed.
• Self-motivated and excited to take on new challenges.

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

$180,000 - $264,000

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.

#WeAreLilly