Advisor/Sr. Advisor - Technical Services/Manufacturing Science

Lilly • Richmond, VA

3d • $129,000 - $209,000 • Onsite

About The Position

The Advisor/Sr. Advisor TS/MS, also known externally as MSAT (Manufacturing Science and Technology), provides technical stewardship across Lilly’s startup advanced manufacturing facility in Goochland County, Virginia. The facility is being built for monoclonal antibodies, bioconjugates, and aseptic drug product manufacturing. This role supports the startup of the site and helps establish the organization, facility, and culture for successful GMP manufacturing operations.

The position provides technical leadership and expertise in bioconjugate manufacturing, with accountability for upstream and downstream processing. It requires deep knowledge of conjugation chemistry, purification and filtration processes, and the analytical and process controls used in bioconjugate manufacturing. The Advisor/Sr. Advisor applies regulatory knowledge, data-driven decision-making, process analytics, and process analytical technology to improve process performance and support the digital plant. This cross-functional technical leader promotes scientific curiosity and technical rigor across the site.

The role is onsite, eight hours per day on a day shift. Occasional evening or weekend support may be needed, and occasional travel may be required.

Requirements

• MSc in Biochemistry, Cell Biology, Biotechnology, Biochemical Engineering, or a related discipline.
• At least 5 years of experience in ADC/mAb development.
• Experience supporting commercial ADC/mAb manufacturing.
• Experience in inspection support.
• Expertise in bioconjugate manufacturing processes, including upstream and downstream processing, conjugation chemistry, purification and filtration, and relevant analytical and process controls.
• Experience with regulatory guidance and familiarity with relevant strategies.
• Strong data-driven decision-making and problem-solving capabilities.
• Strong technical writing and oral communication skills.
• Demonstrated technical acumen and high productivity.
• Strong interpersonal skills and the ability to mentor, teach, and provide technical leadership.
• Initiative, curiosity, learning agility, and adaptability in a fast-paced, dynamic manufacturing environment.
• Ability to participate in and facilitate decision-making.

Nice To Haves

• PhD in Biochemistry, Cell Biology, Biotechnology, Biochemical Engineering, or a related discipline.
• 10 or more years of experience in the biopharmaceutical industry.

Responsibilities

• Provide mentorship and scientific expertise to TS/MS bioprocess and laboratory scientists in process monitoring, trending, and production-data analysis.
• Apply process knowledge and data-analysis skills to support daily manufacturing operations and drive solutions to complex site-wide and cross-functional issues.
• Perform job responsibilities in compliance with safety and regulatory expectations, applying knowledge of cGMP requirements.
• Represent the site technically across the manufacturing network, including drug substance and drug product sites, global functions, and process research and development.
• Review and approve annual product reviews and global product assessments.
• Partner with site leadership to develop, implement, and manage technical agendas that meet regulatory expectations and business needs.
• Mentor scientists, engineers, and operations staff; support troubleshooting; anticipate and resolve technical or operational problems; and communicate issues promptly.
• Lead complex process-related investigations when needed and assess technical impact.
• Partner with quality assurance and quality control to provide technical oversight of control strategies and maintain manufacturing process compliance.
• Author technical reports supporting process control strategies, technology transfers, process validation, deviation and adverse-event reporting, process monitoring and analyses, and technical studies.
• Own or assist with implementation of large process-related change controls involving greater risk, resource or financial requirements, or complexity.
• Support development of regulatory submission strategies and prepare related documentation.
• Communicate and transfer knowledge effectively across organizational levels through technical writing and oral communication.
• Work with scientists and engineers to transfer process knowledge to manufacturing staff and support process-related training.
• Support PAT and data science programs to align program execution with process scientists and control strategies.
• Design laboratory experiments as needed for troubleshooting or continuous improvement, and execute or coordinate work in outside laboratories.
• Help define and implement medium- to large-scale continuous improvements to manufacturing processes.
• Work with Manufacturing to support startup and validation of new facilities, process equipment, and products during technology transfer.
• Help define, implement, and own control strategies for new products.

Benefits

• Company bonus, depending in part on company and individual performance.
• Eligibility to participate in a company-sponsored 401(k).
• Pension.
• Vacation benefits.
• Eligibility for medical, dental, vision, and prescription drug benefits.
• Flexible benefits, including healthcare and/or dependent day care flexible spending accounts.
• Life insurance and death benefits.
• Certain time-off and leave-of-absence benefits.
• Well-being benefits, including an employee assistance program, fitness benefits, and employee clubs and activities.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior