Associate Director – Technical Services/Manufacturing Science - Analytical Support

Eli Lilly and Company; Richmond (VA); On-site; USD 123,000 - 180,000; Full time

Job summary

Eli Lilly and Company is seeking an Associate Director – TS/MS/ MSAT with responsibility for Analytical Support in the Virginia GMP manufacturing startup. You will lead a cross-functional team to ensure robust biology and chemistry processes, driving process monitoring, control strategies, and regulatory readiness.

The role requires 10+ years in analytical development for biologics, 5+ years in people leadership, and experience with CMC submissions.

Qualifications

• BS or higher in biology, biochemistry, chemistry, chemical engineering, or a related scientific discipline.
• 10+ years of experience in analytical development, characterization, or technical support for biologics (mAbs/bioconjugates), including 5+ years in a people leadership role
• Experience in analytical method development for biologic drug substance and drug product
• Experience supporting or authoring CMC regulatory submissions

Responsibilities

• Support site leadership to build a diverse and capable TS/MS organization with the necessary capability, capacity and culture to operate the facility to the highest standards of excellence
• Lead, develop and retain a high-performing team, fostering a culture of technical excellence, curiosity, accountability and continuous improvement
• Provide coaching, mentorship and performance management to direct reports, ensuring individuals are developed to their full potential, and the team is structured for long-term success
• Determine TS/MS staffing and resource needs to support process operations through facility startup to enable successful process qualifications and validations
• Support the development and implementation of robust control strategies to ensure regulatory compliance and operational excellence through lean principles in a digitally native plant
• Review and approve documentation including procedures, deviation investigations, technical reports, change controls, qualification and validation protocols and summary reports
• Support the project team to deliver the facility to the site lead team ready to operate and on schedule

Skills

Leadership

Communication

Teamwork

Adaptability

Education

BS or higher in biology, biochemistry, chemistry, chemical engineering, or related scientific discipline

Advanced degree (MS or PhD) preferred

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.

Lilly is currently constructing an advanced manufacturing facility for monoclonal antibodies, and bioconjugates in Goochland County, Virginia. This facility is intended to provide capacity for current and future products. This is a unique opportunity to be a part of the leadership team for the startup of a manufacturing site, and the successful candidate will help to build the organization, the facility and the culture to enable a successful startup into GMP manufacturing operations.

Job Title: Associate Director – Technical Services/Manufacturing Science (TS/MS / MSAT) - Analytical Support

Organization Overview

The TS/MS organization, also known externally as MSAT (Manufacturing Science and Technology) provides technical oversight to ensure robust and consistent biology and chemistry throughout all aspects of the manufacturing process. Through cross functional collaboration, TS/MS ensures the quality and safety of our products through process monitoring and knowledge to control, prevent and mitigate variability to deliver a reliable supply of medicine.

Responsibilities

The Associate Director – TS/MS - Analytical Support, will lead a technical organization to provide oversight of biological and bioconjugate manufacturing processes in collaboration with engineering, IT, operations and quality functions. TS/MS is responsible for ensuring manufacturing processes run reliably in a state control through process monitoring supported through technical knowledge.

• Support site leadership to build a diverse and capable TS/MS organization with the necessary capability, capacity and culture to operate the facility to the highest standards of excellence
• Lead, develop and retain a high-performing team, fostering a culture of technical excellence, curiosity, accountability and continuous improvement
• Provide coaching, mentorship and performance management to direct reports, ensuring individuals are developed to their full potential, and the team is structured for long-term success
• Determine TS/MS staffing and resource needs to support process operations through facility startup to enable successful process qualifications and validations
• Support the development and implementation of robust control strategies to ensure regulatory compliance and operational excellence through lean principles in a digitally native plant
• Review and approve documentation including procedures, deviation investigations, technical reports, change controls, qualification and validation protocols and summary reports
• Support the project team to deliver the facility to the site lead team ready to operate and on schedule

Basic Requirements

• BS or higher in biology, biochemistry, chemistry, chemical engineering, or a related scientific discipline
• 10+ years of experience in analytical development, characterization, or technical support for biologics (mAbs/bioconjugates), including 5+ years in a people leadership role
• Experience in analytical method development for biologic drug substance and drug product
• Experience supporting or authoring CMC regulatory submissions

Additional Skills/Preferences

• Advanced degree (MS or PhD) in biology, biochemistry, chemistry, chemical engineering, or a related scientific discipline preferred
• Experience in GMP manufacturing operations and supporting regulatory inspections and audits
• Knowledge of manufacturing processes, lab scale models, and unit operations used in the manufacturing of biotech products
• Knowledge of laboratory scale models and commercial scale biotech manufacturing processes
• Strong written and verbal communication skills
• Ability to work on own initiative and as part of a process team consisting of a diverse group of management, production/science and engineering professionals
• Ability to respond quickly and proactively to changing priorities within a limited timeline

Additional Information

• Travel is possible, but expected to be minimal
• Role is Monday through Friday onsite. Must be flexible in providing support to accommodate other inputs (production schedules, shutdowns, etc.). Occasional extended hours and / or off-hour work may be required.

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 $123,000 - $180,400

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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