Pharmaceutical Manufacturing Lead - Dry Granulation
Position Summary
Work Schedule: M-F 6am-2:30pm
100% based on-site in Kansas City
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.
The Role
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
The Candidate
High school diploma or GED and 7+ years of experience with 5+ years in a Pharma or cGMP manufacturing environment required.
Technical degree/certification and 5+ years of experience with 5+ years in a Pharma or cGMP manufacturing environment preferred.
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.
Why you should join Catalent
Career growth with a clear path and regular performance reviews
Day-one benefits: medical, dental, vision
401(k) match , tuition reimbursement, and wellness perks
Paid time off: 152 hours + 8 paid holidays
Inclusive culture with Employee Resource Groups and community initiatives
Discounts from 900+ merchants via Perkspot
A mission-driven workplace where your work helps save lives
Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.
personal initiative. dynamic pace. meaningful work.
Visit Catalent Careers (https://careers.catalent.com/us/en) to explore career opportunities.
Catalent is an Equal Opportunity Employer, including disability and veterans.
If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com . This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.
Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.
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