Supervisor, Hybrid Operations

Role Overview

• The Supervisor provides leadership and direct management to the process operators in the Medicine Foundry operations group.
• 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.
• 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.
• Follow all applicable procedures for quality event reporting and documentation.
• 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) 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 between the shift and functional support groups such as maintenance, engineering, analytical laboratory, and Technical Support.

Requirements

• HS Diploma/GED
• 5+ years experience directly supporting/supervising a manufacturing operation, preferably in a GMP and/or chemical processing environment.
• Qualified applicants must be authorized to work in the United States on a full-time basis.
• 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
• 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.

Benefits

• 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
• well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)