Catalent Pharma Solutions Inc

Supervisor, Manufacturing Sciences & Technology

Catalent Pharma Solutions Inc • $75K — $95K *
Kansas City, MO 64118In-Person
Pharmaceuticals & Biotech
Less than 5 years of experience
1 month ago
Job Overview by Ladders

Qualifications

  • Bachelor's degree in Biotechnology, Chemical or Pharmaceutical Engineering, or equivalent experience required
  • 4+ years of relevant experience in the field if only a HS Diploma/GED is held
  • Proven project management skills, including method transfers and risk assessment
  • Familiarity with regulatory requirements for product development and site transfers
  • Experience in investigating and resolving deviations and change controls
  • Knowledge of thermoforming/cold-forming equipment is essential
  • Strong proficiency in Microsoft Office and packaging software like TOPS Pro

Responsibilities

  • Lead the Manufacturing Sciences & Technology (MS&T) team in strategic client interactions
  • Collaborate cross-functionally with various departments to facilitate process transfers
  • Oversee commercial manufacturing transitions and support process development
  • Boost productivity by identifying and implementing efficiency initiatives
  • Ensure compliance with cGMP during changes to processes and maintain accurate documentation
  • Unify focus across Project Management, Operations, and Quality to achieve product objectives
  • Compile process data and communicate project statuses internally and to clients

Benefits

  • Comprehensive health and wellness benefits
  • Retirement savings plan options
  • Opportunities for professional development
  • Paid time off and holiday leave
  • Supportive team environment focused on collaboration
Full Job Description
Supervisor, Manufacturing Sciences & Technology

Position Summary
  • 100% based on-site in Kansas City
  • Work Schedule: M-F during regular business hours


The Kansas City Clinical Development & Supply Floor Manufacturing Sciences and Technology Supervisor will develop and lead a group, including the transfer between external clients and Manufacturing. The supervisor is responsible for leading the team of strong engineers, scientists, or qualified person to be technology transfer process owner to deliver excellent services to internal and external customers.

The Role
  • Strategic client facing leader of the MS&T team on the behalf of the organization.
  • Works cross functionally with project managers, manufacturing, label design and control, quality assurance, quality control, supply chain, and facilities departments to effectively transfer and maintain processes in the facility.
  • Participates and leads commercial manufacturing transition and support for process development.
  • Enhance productivity by exploring, analyzing, facilitating, and leveraging efficiency initiatives for packaging processes through The Catalent Way.
  • Ensure that changes to existing processes or the introduction of new processes are carried out and documented according to approved change control procedures and in compliance with cGMP requirements.
  • Bridge the focus areas of Project Management, Operations, Quality, EHS, Supply Chain and Engineering to create common understanding and objectives and ensure robust products and flawless packaging.
  • Leads the compilation of process data, including communicating project status, and delivering internal and client presentations.
  • Collects and trend process data for external (Clients) and internal review to ensure process consistency.
  • Provides business case for process improvement projects.
  • Other duties assigned


The Candidate
  • Bachelor's degree in Biotechnology, Chemical or Pharmaceutical Engineering, or related field, OR a HS Diploma/GED and 4+ years of relevant experience required.
  • Experience with Upstream and Downstream processes of cGMP clinical packaging.
  • Project management experience/skills required including method transfers, and risk assessment.
  • Knowledge of regulatory, validation and documentation requirements for product development, commercial production, and site transfers.
  • Experience in investigating and closing out deviations, OOS, CAPAs, and change controls.
  • Experience working on late phase and commercial programs is a plus.
  • Knowledge of thermoforming/cold-forming equipment is required.
  • A good working knowledge of Microsoft Office (Word, PowerPoint, Excel and Visio) and TOPS Pro (Total Optimization Packaging System) or similar software program
  • Ability to learn and use software packages (e.g. TrackWise®, ComplianceWire®).
  • Demonstrated strong working knowledge of Tech Transfer (Internal and External).
  • Understanding and application of Risk Assessment tools (Hazard Analysis, FMEA, etc.).


About Catalent Pharma Solutions Inc

Catalent Pharma Solutions Inc is a global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, gene therapies, and consumer health products. The company operates in four segments: Softgel and Oral Technologies, Biologics, Oral and Specialty Delivery, and Clinical Supply Services. Catalent Pharma Solutions serves customers in various industries, including pharmaceuticals, biotechnology, and consumer health. The company was founded in 2007 and is headquartered in Somerset, New Jersey.
Learn more about Catalent Pharma Solutions Inc
Size
14,000 employees
Industry
Pharmaceuticals & Biotech
Founded
2007
* Ladders Estimates

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