Senior Director Analytical Development Cell and Gene Therapy

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. 

We are seeking a head of Analytical Development within the Cell and Gene Therapy (CGT) Development organization. In this unique high-visibility role, you will define the global enterprise strategy for the maturation, innovation, site bridging, and regulatory alignment of our analytical platform for clinical CGT programs at Lilly through BLA/MAA. Current CGT technologies include AAV, mRNA/LNP, LVV products throughout stages of clinical development.

You will manage the department responsible for the development, registration, commercialization, and analytical control strategies for CGT projects. These responsibilities include method development, qualification and transfer, process development support, non-GMP stability studies, physical and chemical characterization activities, and preparation of relevant portions of regulatory submission documents.

Responsibilities

• Manage the analytical development efforts associated with the commercialization of Lilly CGT products

• Lead and grow a team of approximately 75 FTEs and responsible for:

• Developing and optimizing analytical assays across different stages of drug development for AAV, LVV, gRNA, mRNA, lipids, LNPs

• Testing non-GMP samples to support development studies such as comparability assessments, process development, stability, product and process characterization, etc.

• Collaborating closely with the Quality Control team to transfer and qualify methods at CDMOs, CROs, and internal QC labs

• Enhancing our product and process understanding by characterizing impurities, defining CQAs, process troubleshooting, supporting process control strategies

• Provide input to CGT leadership team on the strategic direction of the department

• Author and review technical documents and regulatory submissions

• Determine resourcing for new projects and make assignments within the department

• Plan budget, capital expenditures, and headcount needs for the department

• Monitor project progress, ensure compliance with program timelines, and serve as a technical resource when issues arise

• Routinely collaborate with leaders in other divisions to ensure alignment of objectives and work processes

• Provide guidance and support to team members, promoting their professional growth and development.

• Foster a culture of lab safety, data integrity, collaboration, innovation, continuous improvement and accountability within the team.

• Ensure that the department keeps current with scientific literature/new technology/capabilities and regulatory initiatives/requirements and their implementation, as appropriate

• Ensure maintenance of the development laboratories, with specific attention to safety in the workplace

• Ensure compliance of the departmental operations with laws, regulations and practices governing the development of new drugs for use in humans

 

Minimum Qualifications

• Education: BS in sciences, analytical chemistry, biochemistry, pharmacy, or related area, advanced degree preferred
• Experience: 15+ years of biopharmaceutical industry experience in roles of progressive leadership and impact 
• Demonstrated history of effective leadership, including hiring and developing top talent
• Experience with method development, qualification, and validation for clinical and commercial products
• Experience in characterization of advanced therapies, ideally AAV, LVV, gene editing, RNA, and/or LNP products
• Experience with international regulatory interactions: writing filings, responding to information requests, scientific advice meetings, etc.
• Excellent written and verbal communication skills; strong communicator and influencer within all levels of the organization, including executive leadership
• Matrix Leadership capability with a proven ability to align cross-functional CMC stakeholders, influence strategy, and mentor technical staff

Additional Information:

Location - Boston MA

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

$ - $

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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