Pharmaceutical Manufacturing Lead - Dry Granulation

Catalent•Kansas City, MO

3d•Onsite

About The Position

Catalent’s Kansas City (KCM) facility is a premier site for integrated drug development, manufacturing, and clinical supply services, supporting a wide range of pharmaceutical and biotech products. With cutting-edge technologies and a collaborative work environment, it offers exciting opportunities for professionals across all functions—from science and engineering to operations and logistics. At the direction of the Supervisor, the Pharmaceutical Manufacturing Lead is responsible for managing and providing direction for efficient set up / tear down, manufacture and cleaning of all equipment and processes associated with manufacturing operations.

Requirements

High school diploma or GED and 7+ years of experience with 5+ years in a Pharma or cGMP manufacturing environment required.
Must have thorough equipment process and framework knowledge, SQDC leadership, process / process scheduling skill.
Must have a thorough knowledge of cGMP, FDA, MHRA and DEA guidelines and how to apply them effectively.
Thorough knowledge of Solid Dosage manufacturing.
Must possess leadership qualities or high potential of team management capability.
Must have a minimum of advanced operator qualification per supervisor / manager specified equipment train(s).
Excellent computer skills.
Able to manage priorities and projects prioritizing effectively.
Must communicate clearly with all levels of management, and manage people well.
Capability to work in a matrix organization.
Demonstrates proficiency in Catalent core competencies per supervisor / manager discretion.
Must be capable of wearing steel-toed safety shoes for 8 to 12 hours a day, depending on duration of the shift.

Nice To Haves

Technical degree/certification and 5+ years of experience with 5+ years in a Pharma or cGMP manufacturing environment preferred.

Responsibilities

Responsible for gathering key performance metrics and reporting to Supervisor / department manager.
Responsible for submitting work orders for processing rooms and equipment within core group.
Ensures 5S standards are met and maintained.
Focuses on driving productivity improvements while maintaining high quality standards.
Ensure that the facility is kept “tour ready” at all times and people/material/flow/cleaning and zone concepts are maintained at all times.
Creates training program for new technicians within core group.
Updates and maintains training program as procedures evolve and continuous improvement ideas are implemented.
Primary trainer for pharmaceutical technicians within core group.
Ensures product is visually inspected to ensure quality requirements are thoroughly met.
Supports multiple shift operations.
Perform transactions in JDE accurately.
Provides information to support core group metrics and efficiency increases.
Drives reductions in unplanned deviations and focuses on troubleshooting identified equipment malfunctions.
Pharmaceutical Manufacturing lead should have high ability to troubleshoot and repair, as well as manage the work order submission / follow-up process to ensure timely completion.
Ability to wear a PAPR (Powered Air Purifying Respirator) during manufacturing when required.
Ability to wear required gowning required to work in the GMP manufacturing areas.
Ensures proper documentation of all batch documents and review and approval of steps performed by other operators.
All other duties as assigned