About Site
Catalent’s Kansas City facility is home to our Oral & Specialty Drug Delivery, Biologics Analytical Services and Clinical Supply Services businesses.
Position Summary
We have an opportunity for a Room Lead, Packaging to join our team supporting clinical trial projects through the packaging of clinical trial supplies. The role ensures compliance with regulatory requirements, good manufacturing practices, and standard operating procedures. This position plays a key part in maintaining quality, meeting production schedules, and delegating job-specific tasks. The Room Lead oversees the execution of all clinical and commercial batch records in primary, secondary, and potent packaging areas while working closely with the Production Supervisor and CSS Team Lead.
Shift: M-F 2:30pm-11pm
Location: Kansas City, MO
100% Onsite
The Role
Ensure that during all packaging operations the site’s safety, quality, and compliance metrics are met or surpassed as well as corporate metrics.
Lead assigned team members and work alongside them to complete clinical trial and commercial packaging jobs daily.
Be responsible for the safety, quality, delivery, and cost (SQDC) of all clinical and commercial outputs.
Understand, interpret, and communicate organizational metrics and goals, leading team members to consistently reach objectives.
Maintain a “Patient First” customer focus mindset.
Exemplify “Humble, Hungry, Smart” team player values and lead by example.
Support a respectful and professional workplace among all team members.
Manage competing priorities and personalities effectively.
Ensure accurate and timely entries into batch records.
Ensure strict adherence to hygiene and gowning procedures.
Alert management of any potential deviations or infractions promptly.
Set up production rooms for efficient, high-quality outputs.
Adhere to current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP) when completing and reviewing production batch records.
Implement and enforce 5S principles with guidance from Team Leads and Supervisors.
Identify, eliminate, or escalate waste within production processes.
Create a positive work environment through effective people leadership.
Troubleshoot downtime in production rooms.
Assess operator strengths and weaknesses to assign tasks effectively during batch execution.
Delegate tasks and ensure completion.
Oversee multiple ongoing production operations as required.
Clear Drug Enforcement Agency (DEA) background check for handling controlled and special security drug substances.
Understand and enforce GMP gowning and de-gowning requirements for each production area.
Follow all site safety, human resource, and security policies.
Perform other duties as assigned.
The Candidate
Minimum Requirements
High School degree or equivalent.
Demonstrated ability to motivate and lead others while working alongside them to complete tasks and reach organizational goals.
Ability to read, write, and speak English effectively.
Strong written and verbal communication skills.
Problem-solving ability.
Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
Ability to lead a team and encourage strong working relationships.
High attention to detail.
Above-average organizational skills aligned with 5S principles.
Self-motivated and able to work with little or no supervision.
Ability to work effectively under pressure to meet competing workplace demands.
Basic to moderate computer skills, including e-mail, Microsoft Outlook, Microsoft Word, Microsoft Excel, Internet Explorer, and inventory systems.
Basic mathematical skills.
Stand, walk, sit, use hands to manipulate, and reach with hands and arms for up to 8–10 hours per day.
Frequent sitting, standing, walking, reading of written documents, and use of computer monitor screen.
Able to work with respirator (P100, PAPR, etc.).
Occasional lifting and/or moving up to 50 pounds.
Occasional requirement to stoop, kneel,…