Supervisor, Manufacturing Sciences & Technology

Supervisor Manufacturing Sciences & Technology

Position Summary

• 100% based on-site in Kansas City

• Work Schedule: M-F during regular business hours

Catalents 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 functionsfrom science and engineering to operations and logistics.

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

• Bachelors 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.).

Why you should join Catalent

• Career growthwith 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 holidays

• Inclusive culturewith Employee Resource Groups and community initiatives

• Discountsfrom 900 merchants via Perkspot

• A mission-driven workplacewhere 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 7000 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 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 . 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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