Advisor/Sr. Advisor - Technical Services/Manufacturing Science
Eli Lilly and Company
5 hours ago
On-site
Richmond, VA
Operations
Role: Advisor/Sr. Advisor TS/MS (MSAT) – Manufacturing Science and Technology
Key Responsibilities:
- Provide mentorship and scientific expertise to TS/MS bioprocess and laboratory scientists for process monitoring, trending, and analyzing production data; support daily manufacturing operations.
- Ensure all work is compliant with safety and regulatory expectations, including cGMP.
- Technically represent the site across the manufacturing network; review and approve annual product review and global product assessment.
- Partner with site leadership to develop, implement, and manage technical agendas aligned to regulatory expectations and business needs.
- Mentor scientists, engineers, and operations staff; troubleshoot; anticipate and resolve key technical/operational problems; may lead complex investigations.
- Partner with Quality Assurance/Quality Control to provide technical oversight of control strategy and ensure processes remain compliant.
- Author technical reports for process control strategies, technology transfers, process validation, deviation/adverse event reporting, process monitoring/analyses, and technical studies.
- Own or assist large, higher-risk process-related change controls.
- Support strategy development for regulatory submissions and related documentation.
- Lead excellence in technical writing and oral communication; transfer knowledge across the organization.
- Support process knowledge transfer to manufacturing and assist with process-related training.
- Support PAT and data science programs to align execution, control strategies, and process scientists.
- Design lab experiments for troubleshooting/continuous improvement; execute/coordinate external lab work; implement medium to large continuous improvements.
- Support start-up and validation of new facilities, equipment, and products during technology transfer; define/implement/own control strategies for new products.
Attributes for the Role:
- Technical acumen and high productivity
- Technical leadership, teaching, and mentoring
- Curiosity and learning agility
- Self-starter; data-driven problem-solving
- Strong interpersonal, verbal, and written communication
- Adaptable to fast-paced manufacturing environments
- Ability to participate in and facilitate decision-making
Educational Requirements:
- PhD or MSc in Biochemistry, Cell Biology, Biotechnology, Biochemical Engineering, or related discipline (with relevant experience)
- Minimum 10 years of biopharmaceutical industry experience
Work Environment:
- 8-hour day shift, onsite; occasional evening/weekend support may be required
- Occasional travel may be required
Benefits (as stated):
- Eligible for company bonus (for full-time equivalent employees)
- Company-sponsored 401(k), pension
- Vacation
- Medical, dental, vision, prescription drug benefits
- Flexible benefits (e.g., healthcare and/or dependent day care FSA)
- Life insurance and death benefits
- Time off and leave of absence benefits
- Well-being benefits (e.g., employee assistance program, fitness benefits, employee clubs/activities)
Compensation (as stated):
- Anticipated wage: $129,000 – $209,000
Key Responsibilities:
- Provide mentorship and scientific expertise to TS/MS bioprocess and laboratory scientists for process monitoring, trending, and analyzing production data; support daily manufacturing operations.
- Ensure all work is compliant with safety and regulatory expectations, including cGMP.
- Technically represent the site across the manufacturing network; review and approve annual product review and global product assessment.
- Partner with site leadership to develop, implement, and manage technical agendas aligned to regulatory expectations and business needs.
- Mentor scientists, engineers, and operations staff; troubleshoot; anticipate and resolve key technical/operational problems; may lead complex investigations.
- Partner with Quality Assurance/Quality Control to provide technical oversight of control strategy and ensure processes remain compliant.
- Author technical reports for process control strategies, technology transfers, process validation, deviation/adverse event reporting, process monitoring/analyses, and technical studies.
- Own or assist large, higher-risk process-related change controls.
- Support strategy development for regulatory submissions and related documentation.
- Lead excellence in technical writing and oral communication; transfer knowledge across the organization.
- Support process knowledge transfer to manufacturing and assist with process-related training.
- Support PAT and data science programs to align execution, control strategies, and process scientists.
- Design lab experiments for troubleshooting/continuous improvement; execute/coordinate external lab work; implement medium to large continuous improvements.
- Support start-up and validation of new facilities, equipment, and products during technology transfer; define/implement/own control strategies for new products.
Attributes for the Role:
- Technical acumen and high productivity
- Technical leadership, teaching, and mentoring
- Curiosity and learning agility
- Self-starter; data-driven problem-solving
- Strong interpersonal, verbal, and written communication
- Adaptable to fast-paced manufacturing environments
- Ability to participate in and facilitate decision-making
Educational Requirements:
- PhD or MSc in Biochemistry, Cell Biology, Biotechnology, Biochemical Engineering, or related discipline (with relevant experience)
- Minimum 10 years of biopharmaceutical industry experience
Work Environment:
- 8-hour day shift, onsite; occasional evening/weekend support may be required
- Occasional travel may be required
Benefits (as stated):
- Eligible for company bonus (for full-time equivalent employees)
- Company-sponsored 401(k), pension
- Vacation
- Medical, dental, vision, prescription drug benefits
- Flexible benefits (e.g., healthcare and/or dependent day care FSA)
- Life insurance and death benefits
- Time off and leave of absence benefits
- Well-being benefits (e.g., employee assistance program, fitness benefits, employee clubs/activities)
Compensation (as stated):
- Anticipated wage: $129,000 – $209,000