Supervisor, Biologics Operations - Lilly Medicine Foundry

Job Position Overview

The Supervisor provides leadership and direct management to the process operators in the Medicine Foundry operations group. The Supervisor is the management representative on shift. The Manufacturing Supervisor actively supports and oversees start-up activities to bring manufacturing equipment into service. The Supervisor leverages knowledge on their team and educates the team on the proper operation of the facility. This role requires domestic and international travel to collaborate, train, and learn from sites that currently produce APIs.

Upon completion of the project phase, the Supervisor oversees the production of API molecules. The Supervisor ensures the team consistently employs a safety-first, quality-always approach while managing a production process that encompasses diverse unit operations and manufacturing skills.

Responsibilities:

The Supervisor is responsible for overseeing the safety and quality of products and compliance of equipment and buildings. They assist in delivering the production schedule and supervise process operators in the Lilly Medicine Foundry business. As a Process Team member, the Supervisor will provide initial management responses to events and manage employee relations for all shift personnel. Additionally, they will be part of the Foundry production and building management teams, sharing responsibility for meeting production targets. In line with the job outlined above, the following are typically the key tasks that would be expected of the role:

• Responsible to enforce adherence to compliance requirements (safety, quality, and environmental) and appropriately escalating any adverse events.
• Overseeing operation of processes and equipment according to batch records, user manuals, design parameters, standard operating procedures, and work instructions to meet production schedule.
• Oversee monitoring, testing, cleaning, and operation of area equipment and systems. Ensure all systems are in good operating condition and maintained per applicable requirements.
• Serve as a key leader for site safety culture, promoting compliant operations and positive safety behaviors. Lead by example and promote accountability at all levels.
• Provide technical leadership for troubleshooting and reaction to process upsets, integrating operator input and escalating as appropriate.
• Follow all applicable procedures for safety event reporting and documentation. This includes following appropriate spill response procedures, escalation of issues, and initiating Emergency Response procedures as needed.
• Follow all applicable procedures for quality event reporting and documentation. This includes entry/completion of GMP deviation records, interface with Quality Assurance, and escalation of issues as needed.
• Oversee communication between shifts regarding the status of area operations and addressing any issues/problems that have occurred at shift passover.
• Participating in daily shift huddles/meetings to understand and set expectations for daily operational goals.
• Lead and make assignments for building and area operations such as safety audits, procedure coordination, housekeeping, and continuous improvement projects.
• Ensure all area personnel follow cGMP practices, safe work habits, plant dress code, hygiene standards, and housekeeping requirements unique to the work area and job classification.
• Enforce use of specified company-supplied personal protective equipment (PPE) (e.g., hair and beard coverings, lab coats or gowns, safety shoes, safety glasses, hard hats, etc.) as required.
• Responsible for the effective deployment of operators to meet production schedules, maintaining adequate cover for Emergency Response Teams, managing holiday and overtime levels across process and production operators, timecard and coding for process operators.
• Responsible for individuals' performance on shift, managing employee relations and completing annual performance management processes.
• Ensure that all shift members are appropriately trained, and that operating procedures and training material are available and current.
• Partner with area Associate Director to understand Foundry strategy and future production needs. Represent and support this strategy in conversations with shift members.
• Manage collaborations, both formal and informal, between the shift and functional support groups such as maintenance, engineering, analytical laboratory, and Technical Support.

Basic Requirements:

• HS Diploma/GED
• API supervisory experience required.
• Internal applicants: K360 supervisory experience required.
• 5+ years experience directly supporting/supervising a manufacturing operation, preferably in a GMP and/or biologics/biotechnology processing environment.
• 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 Skills/Preferences:

• Bachelor's or Associate's Degree in science, engineering, or technical field
• Previous experience in facility/area start-up environments Previous experience in pharmaceutical manufacturing operations
• Experience with single use technology platforms for media and buffer preparation, including operation of single-use mixing systems and membrane-based filtration assemblies in a GMP environment
• Experience with upstream bioreactor operations using single-use bioreactor (SUB) systems, including inoculum expansion, cell culture scale-up, and oversight of seed train processes in a biologics manufacturing environment
• Experience with downstream purification operations using single-use technology, including depth filtration, tangential flow filtration (TFF), viral inactivation/filtration, and single-use chromatography systems for API capture and polishing
• Demonstrated leadership experience
• Skills in providing/receiving feedback and creating employee development plans
• Basic computer skills (desktop software) are required.
• Solid understanding of FDA guidelines and cGMP requirements.
• Knowledge of lean manufacturing principles
• Ability to work with a team, make independent decisions, and influence diverse groups.
• Ability to instill teamwork within the shift and demonstrate key interpersonal skills.
• Ability to communicate verbally and in writing to various audiences, particularly one-on-one coaching and feedback with direct reports.
• Excellent interpersonal, written and oral communication skills
• Strong organizational skills and ability to handle and prioritize multiple requests.
• Strong technical proficiency and ability to train and mentor others.

Additional Information:

• Position Location: US: Lebanon IN Lilly Medicine Foundry, initial location in Indianapolis, IN during pre-startup phase
• Travel Percentage: 10%
• Must be able to work a rotating 12-hour shift
• May be required to provide support outside of normal working hours including nights, weekends, and holidays.
• Ability to travel to other Lilly locations for training purposes