Drug Substance Process Ops Shift Mgr

Job title:

Drug Substance Process Ops Shift Mgr

Company:

MSD

Job description

Job DescriptionAn amazing opportunity has arisen for a Drug Substance Process Operations Shift Manager, at our Biologics Innovation in Dunboyne, Co. Meath. The successful candidate will be accountable for end-to end production supporting Solution Supply, Batch and Continuous Manufacturing. This requires the management of a stable process supported by a flexible, collaborate, multi-skilled teamwork environment.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 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.Key responsibilities will include

• Inspire Diversity and Inclusion – building working effective working relationship within a cross-functional team across diverse cultures and backgrounds.
• Contributes to the overall goals of the team by excelling at their individual role and taking initiative to improve their own leadership and technical/functional skills.
• Implement and oversee tier 0 and represent the area(s) at tier 1 and tier 2, ensuring appropriate level of preparedness of any escalations, fostering a culture of openness, collaboration, and attention to detail to achieve schedule/project task delivery.
• Recognizing that action is required and working to generate alternatives, generate options and choosing effective options, knowing when other stakeholders support is needed.
• Drive operational excellence to deliver all components of a stable process for PPQ, facility start-up and commercial supply.
• Maintain area in GMP Compliance and maintain team training. Collaborate with other teams or departments to ensure cross-functional compliance.
• Oversee the development and approval of GMP Documentation such as: Risk Assessments, change control management, Elogs, EBRs, SOPs.
• Embody Safe by Choice – know and follow the Safety, Health and Environment guidelines and work towards company safety and environment goals.
• Influences, partners, and collaborates with other colleagues within and outside their team to build trust encourage two-way communication and strengthen relationships.
• Change management leadership demonstrating adaptability and openness to change, exploring the benefits, and collaborating with others to make it effective.

People Management

• You will be responsible for setting performance goals, conducting performance evaluations, and identifying training and development opportunities for your team.
• Provide your team with the tools and development opportunities (including educational assistance, job rotation, cross-functional training, Six Sigma) to make them successful.
• Assessing workload, identifying gaps or imbalances, and reallocating resources or making hiring decisions to optimize staffing levels and ensure efficient operations.
• Foster a feedback culture within the team or organization, encouraging open and honest communication.

Your profile

• 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 analysing complex situations and show practical problem-solving capabilities.
• Demonstrated ability to make and act on decisions while balancing speed, quality, and risk.
• 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 requirements
• Experience and understanding of SAP, Emerson DeltaV, MES PAS -X, and the use of Automation in a manufacturing Process.
• Experience in quality management systems and operating systems such as Veeva, SAP.

We keep the patient at the very heart of all that we do and strive to find solutions and treatments for some of the world’s most challenging healthcare needs. We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment.So, if you are ready to:Invent solutions to meet unmet healthcare needs, Impact the future by driving one of the world’s leading healthcare companies, and inspire your team to reach their full potential and push the boundaries of science and technology, please apply today.Current Employees applyCurrent Contingent Workers applySearch 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: RegularRelocation:VISA Sponsorship:Travel Requirements:Flexible Work Arrangements: Not ApplicableShift:Valid Driving License:Hazardous Material(s):Required Skills: Applied Engineering, Applied Engineering, Contamination Control, Cross-Cultural Collaboration, Cross-Team Coordination, Data Analysis, Engineering Standards, Equipment Maintenance, Estimation and Planning, GMP Compliance, Maintenance Supervision, Management Process, Manufacturing Process Improvements, Occupational Health and Safety Management, Operational Excellence, People Leadership, People Management, Pharmaceutical Manufacturing, Process Improvements, Product Formulation, Quality Management Systems (QMS), Readiness Assessments, Regulatory Compliance, Regulatory Requirements, Risk Assessments {+ 5 more}Preferred Skills:Job Posting End Date: 06/17/2025*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Expected salary

Location

Dunboyne, Co Meath

Job date

Thu, 05 Jun 2025 03:56:36 GMT

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