Drug Substance Process Operations Operational Excellence Snr. Specialist

Job Description An amazing opportunity has arisen for a Drug Substance Process Ops Operational Excellence Lead to provide compliance support for Drug Substance Process Operations of the Late Stage and Launch Pipeline at our new state of the art single use biotechnology facility in Dunboyne, Ireland. The DSP Ops Operational Excellence Lead is accountable for end-to end production supporting production (Cell Expansion, Upstream, Downstream, Solution Supply) in the area of GMP compliance for both Batch and Continuous Manufacturing The Biologics Innovation facility at Dunboyne is a premier, state-of-the-art facility that enables and advances our best work. By integrating leading-edge technology with a dynamic, activity-based workspace, the facility will support seamless connection and collaboration within and across teams and functions. The facility, will provide Biologics Drug Substance manufacturing for Clinical Supply, Registration & Commercial Launch. Dunboyne serves as a magnetic force that attracts, recognizes, and integrates people of diverse backgrounds and perspectives. Employees will feel not only that they belong in the Dunboyne, but that the facility belongs to and is shaped by them. Bring energy, knowledge, innovatiofn to carry out the following:

• Ability to solve problems and take new perspectives on existing solutions with a desire to continuously learn, improve and develop.
• A Change and QRA Champion within the organization and site, to bring about new technologies, digitization, and identify opportunities to bring new ways of working.
• Use the extensive operational experience to mentor new members of staff in specific plant activities when required and as a key point of contact for external groups.
• Conduct work activities in a safe and compliant manner.
• Support weekend or on-call duty on select time frames to support manufacturing as POC (point of contact) and POE (point of escalation).
• Lead, facilitate and participate daily on cross-functional teams to collaboratively actively to cover compliance topics.
• Coordinates compliance-specific tasks within Drug Substance Process Operations and represents them in cross-group meetings such as Change Review-, Risk Assessment- Deviation-boards, GMBR boards and Audits preparations
• Lead n investigations and risk assessments related to deviations/ complaints and changes, ensuring appropriate actions are implemented timely.
• Responsible for monitoring operational performance, follow-up on any significant adverse trends for the identification and implementation of operational optimization, and robustness improvement projects.
• Evaluate new and prospective regulatory guidance and industry best practice and determine impact on Quality systems, identifying and implementing appropriate updates where required.

What skills you will need:

• Bachelor’s degree in Biotechnology, Chemistry, Biology, Pharmacy, or Process engineering.
• 6 years + experience in Biotech industry (bulk manufacturing of pharmaceutical or biological components). Position level will scale with experience level of candidate.
• Competent in analyzing complex situations and show practical problem-solving capabilities.
• Ability to work independently and within a cross-functional team.
• Demonstrated experience in QRM, Investigations and Problem solving
• Familiarity with contamination control and batch release requirement
• Experience in quality management systems such as Veeva, SAP, PAS-X etc..
• Experience in Quality Assurance, Quality Control within the Biological and/or pharmaceutical industry.

Preferred Experience and Skills:

• Commissioning and Qualification experience
• Problem, Deviation, and Change Management experience
• Understanding of Upstream and Downstream Unit Operations for mAb manufacturing
• Familiarity with Emerson DeltaV, SIPAT, and the use of Automation in a manufacturing Process.
• Familiarity with contamination control and batch release requirements

So, if you are ready to: Invent solutions to meet unmet healthcare needs, please apply today Current Employees apply HERE Current Contingent Workers apply HERE Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: VISA Sponsorship: Travel Requirements: Flexible Work Arrangements: Hybrid Shift: Valid Driving License: Hazardous Material(s): Requisition ID: R289350#J-18808-Ljbffr