Pharmaceutical Manufacturing Lead - Wet Granulation

Company: Catalent Pharma Solutions ( Learn More )

General Information
US-MO-Kansas City
N/A
Not Specified
Full-Time
Not Specified
None
False
False
Job Description

Job Description

Pharmaceutical Manufacturing Lead – Wet Granulation

Position Summary

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. This position will have no direct reports.

The Role (daily responsibilities):

  • Responsible for ensuring cGMP compliance and generally good housekeeping.
  • 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.
  • Creates training program for new technicians within core group. Updates and maintains training program as procedures evolve and continuous improvement ideas are implemented.
  • Ensuring that the facility is kept “tour ready” at all times and people/material/flow/cleaning and zone concepts are maintained at all times.
  • Ensures product is visually inspected to ensure quality requirements are thoroughly met.
  • Ensure communication / execution of quality system improvement ideas provided by team, and commit to maintaining effectiveness of quality system components relevant to process. 
  • Ensures that the Operators are adhering to all Catalent safety procedures and identifying/communicating the necessary adjustments to address potential safety concerns. 
  • Will also ensure the proper use of PPE (Personal Protection Equipment)
  • Works with other Pharmaceutical Manufacturing leads to ensure proper timing and coordinate smooth hand offs between core groups to ensure goals are being met.
  • Focuses on driving productivity improvements while maintaining high quality standards
  • Drives reductions in unplanned deviations and focuses on troubleshooting identified equipment malfunctions. Pharmaceutical Manufacturing lead should have high ability to trouble shoot and repair, as well as manage the work order submission / follow-up process to ensure timely completion.
  • Supports and contributes to processing investigation/deviation analysis with GMP Support.
  • Ensures proper documentation of all batch documents and review and approval of steps performed by other operators. (Pharmaceutical Manufacturing lead must be able to sign performed by & verified by steps).
  • Provide feedback to scientists on batch record template issues to ensure clarity for processing.
  • Ensures that areas of control are processing under GMP conditions and applicable SOP’s are being strictly followed
  • Works collectively with Warehouse and Supply Chain and other necessary areas to ensure timelines are met and results achieved. Responsible for managing material movement with WHS personnel so material delivery to processing room occurs on time.
  • Supports customer requests as needed
  • Supports multiple shift operations.
  • Primary trainer for pharmaceutical technicians within core group. Will also evaluate associates training to identify any gaps or areas for improvement.
  • Participates in site committees such as EHS, Employee engagement or Quality committees.
  • Perform other duties as needed.
  • The Candidate (requirements):

    A high school diploma is required. A technical degree or certification is preferred. May substitute equivalent years of pharmaceutical manufacturing supervisory experience for education.

    The minimum level of total work-related experience required to perform the job’s responsibility is:

    High school diploma + seven to ten years of experience with a minimum of five years in a Pharma or cGMP manufacturing environment, OR

    Technical degree/certification + five to seven years of experience with a minimum of five years in a Pharma or cGMP manufacturing environment.

    Knowledge/Skills Requirements: 

  • Must have thorough equipment process and framework knowledge, SQDC leadership, process / process scheduling skills
  • 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).
  • Must have a thorough knowledge of cGMP, FDA, MHRA and DEA guidelines and how to apply them effectively. 
  • Thorough knowledge of Solid Dosage manufacturing preferred. 
  • 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. 
  • Physical Requirements: 

  • Handling of raw materials for product assembly
  • Manipulation of drums to and from 6-inch pallets
  • Drum weight
  • Maneuvering of drums in manufacturing area consisting of rolling, scooting, pushing and pulling (up to 80 lbs. of force)
  • Utilization of scoops and other hand held implements
  • Lifting boxes and/or containers from waist to chest height
  • Loading product of various amounts of completion to counters and quality control devices
  • Overhead lift and reach (≤15 lbs.)
  • Handling of finished product
  • Manipulation of drums to and from 6-inch pallets (up to 80 lbs. of force)
  • Push and pull ingredient canisters
  • Cleaning of area and equipment
  • Utilizing hand held brushes, wands, hoses, and other cleaning utensils
  • Operating in various postures
  • Overhead reach, squatting, kneeling, and forward bending
  • Transport of materials to and from designated lab space
  • Use of various job task dependent tools and work saver equipment including pallet jacks and Grasping Lifts
  • Coordination in a manufacturing setting, e.g., climbing up/down ladders or maneuvering around drums or between equipment
  • Operating safely in a dynamic environment which includes mobile and fixed equipment and changing conditions while completing job tasks that range from simple to complex and/or multi-tasking
  • Must be able to wear safety glasses, or specified eye protection, in all designated areas
  • Must be able to follow any applicable plant safety requirements
  • Must be fit-tested, trained and capable of wearing air purifying respirator
  • Must be trained in plant hazardous material procedures
  • Must be able to use approved fall prevention devices when performing elevated tasks
  • Must be capable of wearing steel-toed safety shoes for 8 to 12 hours a day, depending on duration of the shift
  • Position Benefits

  • Medical, Dental, Vision and 401K are all offered from day one of employment
  • 19 days of paid time off annually
  • Potential for career growth within an expanding team
  • Defined career path and annual performance review and feedback process
  • About Catalent

    Catalent offers rewarding opportunities to further your career!  Join the global drug development and delivery leader and help develop some of the nearly 200 products we launch each year or help supply over 7,000 products for patients around the world. Catalent is an exciting and growing international company where our professionals 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, for the benefit of patients globally.

    Catalent. More products. Better treatments. Reliably supplied. ™
    Visit www.catalent.com/careers to explore career opportunities, or contact us at 1 877 503 9493.

    Catalent is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, or protected veteran status. 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 along with the job number and title to [Click Here to Email Your Resumé]. This option is reserved for individuals who require accommodation due to a disability. Information received will be routed to a 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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