Supervisor, Production Operations

Kindeva Drug Delivery•Brentwood, MO

1d•Onsite

About The Position

Our Work Matters Kindeva is a leading global contract developer and manufacturer (CDMO) with delivery platform expertise in Autoinjector, Inhalation, Transdermal/Intradermal Patch Technologies. We partner with our customers to improve patient outcomes around the world. Together, as One Team, we will manufacture many more tomorrows. The Impact You Will Make Supervision of a production unit at the Sterile Production Manufacturing (SPM) facility, support services operations and (union) operators. Responsible for ensuring production and support services are performed in compliance with cGMP’s and following Standard Operating Procedures (SOPs). ROLE RESPONSIBILITIES: Instructs the operations of (union) operators and staff in the daily duties and assures they are performed in a timely manner and in conformance with cGMP at SPM (Sterile Manufacturing Facility). Departmental duties include prep of sterile components/machine parts and/or sterile filling operations. Supervises operations to ensure adherence with all Safety requirements when working with autoclaves, Water for Injection (WFI), machine parts and/or sterile fillers. Immediately addresses all safety events or concerns with Environmental, Health and Safety (EH&S) personnel. Performs GMP audits of the aseptic processing area and/or supporting areas as required and investigates any process deviations; perform daily reviews of area documentation (including batch records) for accuracy and ensures compliance with Standard Operating Procedures and adherence to aseptic processing requirements. Composes new or revises departmental SOPs as required. Reports any significant shift activities to the Manager/TL; root cause analysis and ability to define effective corrective/preventative action. Coordinates personnel activities Maintains inventory on materials and sterile items used in the at SPM facility. Sustains and improves labor standards. Assist with the development and maintenance of the annual department overhead budget and orders supplies for area. Schedule shift to maintain hands-on support with operators; fill in for other supervisors as needed. Maintain communications with supporting teams (i.e, Work Team Enablers/MRCs for documentation and SOP’s: with Materials and Planning for scheduling of operations and ordering of materials; with Manager/TL to report daily activities and receive information on activities for the area; and with MQA for any quality issues/concerns. Assists the Production Manager with special projects and other duties as assigned.

Requirements

Education: HS Diploma/AA degree required; Bachelor's degree in Engineering, Chemistry, Computer Science or other Technology or Life Science field preferred.
Experience: 3-5 years previous supervisory experience required and/or combination of education and experience. Pharmaceutical or manufacturing experience highly desirable.
Language Skills: Effective written and oral communication skills required. Excellent written skills in English. Good verbal communication and ability to coach and provide guidance to others.
Computer Skills: Computer literate, with skills in managing Microsoft Applications, PLS, Trackwise.
Reasoning Ability: Demonstrated reading comprehension and writing proficiency at level that meets ‘role’ and/or ‘test’ requirements. -Ability to effectively communicate within a diverse group resulting in desired outcomes. Proven record of problem solving, decision making skills and application of process improvement tools.
Physical Demands: Ability to stand upright for several consecutive hours absent of any medical restrictions which could restrict completion of required duties. Additional requirements are line and product specific.
Work Environment: Use of eye protection, gloves and other PPE is required. Maintaining aseptic area certification may be required. Aseptic gowning procedures will be required. Aseptic gowning requires all body parts to be completely covered (gowned) for substantial periods of time. Practices and promotes safe working environment at all times. Self-starter, team player, with strong interpersonal and coaching skills

Responsibilities

Instructs the operations of (union) operators and staff in the daily duties and assures they are performed in a timely manner and in conformance with cGMP at SPM (Sterile Manufacturing Facility). Departmental duties include prep of sterile components/machine parts and/or sterile filling operations.
Supervises operations to ensure adherence with all Safety requirements when working with autoclaves, Water for Injection (WFI), machine parts and/or sterile fillers. Immediately addresses all safety events or concerns with Environmental, Health and Safety (EH&S) personnel.
Performs GMP audits of the aseptic processing area and/or supporting areas as required and investigates any process deviations; perform daily reviews of area documentation (including batch records) for accuracy and ensures compliance with Standard Operating Procedures and adherence to aseptic processing requirements.
Composes new or revises departmental SOPs as required.
Reports any significant shift activities to the Manager/TL; root cause analysis and ability to define effective corrective/preventative action.
Coordinates personnel activities
Maintains inventory on materials and sterile items used in the at SPM facility.
Sustains and improves labor standards.
Assist with the development and maintenance of the annual department overhead budget and orders supplies for area.
Schedule shift to maintain hands-on support with operators; fill in for other supervisors as needed.
Maintain communications with supporting teams (i.e, Work Team Enablers/MRCs for documentation and SOP’s: with Materials and Planning for scheduling of operations and ordering of materials; with Manager/TL to report daily activities and receive information on activities for the area; and with MQA for any quality issues/concerns.
Assists the Production Manager with special projects and other duties as assigned.