Microbiologist - Contamination Control and Environmental Monitoring Lilly Medicine Foundry

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 tests 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.

Skills

• 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.).

Benefits

• Limited domestic and international travel (< 5%) may be required for this role.
• Role requires ability to work in manufacturing and laboratory environments.
• As a manufacturing support function, the need for occasional evening or weekend support can arise.

Pay

Initial location at Indianapolis/Carmel location.
Permanent location at the new Lilly Medicines Foundry in Lebanon, Indiana.
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $66,000 - $171,600.

Schedule

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).