Associate Director – Technical Services/Manufacturing Science - Analytical Support

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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