Senior MSAT Advisor — Bioconjugate Manufacturing Startup

Biopharma Careers; United States; On-site; USD 129,000 - 209,000; Full time

Benefits offered by this job

401(k)

Pension

Vacation benefits

Medical, dental, vision benefits

Flexible benefits

Life insurance

Time off and leave benefits

Well-being benefits

Performance bonus

Job summary

Lilly is building a start-up level advanced manufacturing facility in Virginia and seeks a senior MSAT advisor to provide technical stewardship across bioconjugate manufacturing. You will lead data-driven decisions, guide process improvements, and mentor cross-functional teams in a fast-paced environment.

The role requires PhD or MSc in relevant fields and 3+ years in biopharma; 10+ preferred. On-site, with travel as needed, and strong emphasis on cGMP compliance and regulatory readiness.

Qualifications

• PhD or MSc required in Biochemistry, Cell Biology, Biotechnology, Biochemical Engineering or related discipline.
• Minimum of 3 years of experience in the biopharmaceutical industry.
• 10+ years of experience preferred in the biopharmaceutical industry.

Responsibilities

• Provide mentorship and scientific expertise to TS/MS bioprocess and laboratory scientists for process monitoring, trending, and analyzing production data.
• Ensure compliance with safety and cGMP requirements.
• Represent the site technically across the manufacturing network and review annual product reviews.
• Partner with site leadership to develop and manage regulatory-compliant technical agendas.
• Mentor scientists, engineers and operations staff and support troubleshooting.
• Provide technical oversight with QA/QC to ensure control strategy compliance.
• Author technical reports for process control strategies, tech transfers, validation, deviations and studies.
• Lead large process-related change controls and coordinate risk assessment.
• Support regulatory submission strategy and related documentation.
• Communicate effectively across all levels of the organization.
• Transfer process knowledge to manufacturing staff and assist in training.
• Support PAT and data science programs for alignment of execution and control strategies.
• Design laboratory experiments for troubleshooting and continuous improvement.
• Support startup and validation of new facilities, equipment, and products during tech transfer.

Skills

Data-driven decision-making

Problem-solving

Technical leadership

Mentoring

Cross-functional collaboration

Education

PhD or MSc in Biochemistry, Cell Biology, Biotechnology, Biochemical Engineering or related discipline

Job description

Lilly is building a start-up level advanced manufacturing facility in Virginia and seeks a senior MSAT advisor to provide technical stewardship across bioconjugate manufacturing. You will lead data-driven decisions, guide process improvements, and mentor cross-functional teams in a fast-paced environment.

The role requires PhD or MSc in relevant fields and 3+ years in biopharma; 10+ preferred. On-site, with travel as needed, and strong emphasis on cGMP compliance and regulatory readiness.