Microbiologist - Contamination Control and Environmental Monitoring Lilly Medicine Foundry

Organization Overview

Lilly recently announced a $4.5 billion investment to create the Lilly Medicine Foundry, a new center for advanced manufacturing and drug development. The first-ever facility of its kind, combining research and manufacturing in a single location, the Medicine Foundry will allow Lilly to further develop innovative solutions to optimize manufacturing processes and increase capacity for clinical trial medicines, while also reducing costs and environmental impact.

Position Overview

The Process Translation and Execution (PTE) team translates API/DS process knowledge into clinical supply readiness, oversees technology transfer, implements phase-appropriate control strategies, and ensures right-first-time clinical manufacturing for a variety of modalities, including synthetic molecules, biologics, peptides, oligonucleotide, and bioconjugates. Through cross-functional collaboration, PTE influences process design, revolutionizes clinical manufacturing, builds capabilities in emerging technologies and aligns with corporate and LRL goals, drives scientific excellence and innovation to accelerate manufacturing advancements and propels the site toward long-term business success.

Responsibilities

• Work with the network and development organizations to ensure a well-understood, robust and fit-for-purpose microbial control strategy is developed and transferred.
• Establish and own the environmental monitoring program, including development of baseline EMPQ protocols and ongoing monitoring.
• Utilize an in-depth knowledge of microbiological controls and associated analytical ss to develop and oversee the contamination control strategy, FMEA and contamination response plan.
• Implement innovative digital solutions to support accelerated manufacturing processes while ensuring compliance and monitoring needs are documented in electronic systems.
• Collaborate as part of cross-functional teams, and establish partnerships with applicable functions, operations and analytical labs to understand interface between the science/engineering with the operations on the floor and bring deep technical expertise to the team.
• Create, revise, or review documents such as: SOPs, material specifications, protocols, and trend reports (water, environmental monitoring, etc) and performs investigations as needed.
• Support tech transfer of new entities through assessment of molecule-specific control strategies and critical quality attributes.
• Understand basic statistical methodologies to assign specifications, acceptance criteria, sampling criteria and analysis of batch data for summary reports and product reviews.
• Identify process vulnerabilities and participate in implementation of continuous improvement initiatives.
• Understand and ensure compliance with safety, compliance, and regulatory expectations.

Requirements

• Minimum BS or MS in microbiology or related discipline.
• 8+ years of experience (BS) or 5+ years of experience (MS) in facility contamination control and environmental monitoring programs in a clinical or GMP manufacturing environment.

Qualifications

• Qualified applicants must be authorized to work in the United States on a full-time basis.
• Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.

Additional Preferences

• Capable of collaborating effectively within a team, making autonomous decisions, and influencing a diverse range of groups in a fast-paced environment.
• Strong communication skills, both oral and written to effectively communicate technical information in a clear and concise manner.
• Skilled at developing innovative solutions to plant challenges by applying problem-solving techniques and interpersonal strengths, while integrating insights from multiple functional areas.
• Self-starter with high initiative and data-driven approach to problem-solving.
• Proficient in MS Office (Word, Excel, Project, Outlook, etc.).