Supervisor, Production Operations(2nd Shift)

Kindeva Drug Delivery•Brentwood, MO

17h•Onsite

About The Position

Kindeva is a leading global contract developer and manufacturer (CDMO) specializing in Autoinjector, Inhalation, and Transdermal/Intradermal Patch Technologies, dedicated to improving patient outcomes worldwide. This role involves the supervision of a production unit at the Sterile Production Manufacturing (SPM) facility, including support services operations and union operators. The Supervisor is responsible for ensuring that all production and support services adhere to cGMP standards and Standard Operating Procedures (SOPs).

Requirements

HS Diploma/AA degree required
3-5 years previous supervisory experience required and/or combination of education and experience
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 literate, with skills in managing Microsoft Applications, PLS, Trackwise
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
Ability to stand upright for several consecutive hours absent of any medical restrictions which could restrict completion of required duties
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
Position requires regular on-site attendance – this position cannot be performed on a remote or telecommute basis on a temporary, short- or long-term basis
Must have the ability to simultaneously multi-task across multiple capabilities and functions and handle multiple competing priorities and requirements, including performing site and functional responsibilities, responding to email and phone communications and attending meetings
Must have the ability to effective manage strict production, time and performance deadlines
Must be willing to work a variable and irregular shift beyond the hours typically defined as a ‘regular’ work day

Nice To Haves

Bachelor's degree in Engineering, Chemistry, Computer Science or other Technology or Life Science field preferred
Pharmaceutical or manufacturing experience highly desirable

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.