Job Description

　　Summary

　　The Supervisor in this role will be part of a cohesive team responsible for suite readiness for all phases of manufacturing. The Manufacturing Supervisor uses expert knowledge of cGMP regulations to ensure manufacturing readiness. The incumbent will also support equipment, documentation, investigations and improvement initiatives within the manufacturing operations. Works independently with minimal supervision and direction. Performs work that consistently requires independent decision making and the exercise of independent judgment and discretion.

　　Day Shift 7AM-7PM on a rotating 2/2/3 schedule

　　Responsibilities

　　Lead a team of manufacturing technicians.

　　Practices and promotes safe work habits and adheres to safety procedures and guidelines.

　　Performs training with staff on the floor, as needed.

　　Lead Tier 1 and Tier 2 meetings and drive accountability.

　　Work with the Lead Associate to ensure that team is prepared for operations in advance.

　　Continuously builds a high-performance diverse team of people to achieve objectives.

　　Provides frequent feedback and coaching to others on ways to improve performance.

　　Partners in coordination with team to review batch records for accuracy and completeness.

　　Creation and maintenance of GMP Kanban in support of manufacturing operations.

　　Uses manufacturing process knowledge and investigational skills to identify and compliantly resolve manufacturing issues.

　　Review/Redline/Approve SOPs, Protocols, Batch Records

　　Quality System: Deviation, Change Controls, CAPAs.

　　Regularly audit process operations to identify potential areas of improvement.

　　Support continuous improvement in process operations and systems.

　　Works with cross-functional teams to support complex investigation close outs, determine root causes and implement appropriate corrective and preventive action.

　　Supports the development of consistent manufacturing standards for controlled documents used within cGMP manufacturing.

　　Review document revisions (i.e. batch production records and manufacturing procedures).

　　Team with Engineering to ensure equipment readiness for campaign start.

　　Support tech transfer activities.

　　Builds cross-functional relationships and enhances relationships with team members.

　　Works cooperatively with others to meet group and organizational goals.

　　Develops employees.

　　Meet with team regularly to discuss goals, planning, and progress.

　　Develops self and others to improve performance in current role and to prepare for future roles.

　　Seeks and welcomes feedback and responds to coaching.

　　Provides frequent feedback and coaching to the team on ways to improve performance.

　　Recognizes and celebrates team successes.

　　Expected to spend at least 60% of time on the manufacturing floor.

　　Education/Experience

　　HS Diploma/GED required.

　　Bachelor’s degree preferred (Science, Technology, Engineering, or Math).

　　Minimum of 5 years of experience in pharmaceuticals manufacturing preferred.

　　2 years of supervisory experience highly desired.

　　Knowledge/Skill/Abilities

　　Strong attention to detail.

　　Ability to work closely and effectively in a team environment.

　　Demonstrated ability to motivate team.

　　Demonstrate initiative and drive to accomplish the job timely, accurately and safely the first time is required.

　　Ability to apply knowledge of Good Manufacturing processes.

　　Ability to apply knowledge and skills in pharmaceutical processes, equipment, instrumentation, and procedures.

　　Ability to understand the science behind the process with ability interpret data and inputs.

　　Adhere to all Personal Protective Equipment (PPE) requirements used within cGMP manufacturing.

　　Strong interpersonal and communications skills (written and oral).

　　Physical Requirements

　　Gown aseptically and/or sterile gown as needed.

　　Write, read/review written documentation for extended periods of time. Specific vision requirements for this job include close vision, distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus.

　　Regularly required to talk and hear.

　　The employee frequently is required to sit and stand for extended periods.

　　The employee is occasionally required to lift, stand; walk; use hands to finger, handle, or feel; reach with hands and arms; and stoop, kneel, or crouch.

　　This position will generally require the ability to work 7am-7pm on rotating days in a 24/7 operation to include holidays.

　　Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.