Job Description

A fantastic opportunity has arisen in Dublin (Biotech), for an Operations Director (Upstream Cell Culture Biotech Drug Substance & Integrated Process Team Lead). Our state-of-the-art, digitally advanced facility delivers life changing biotech medications to patients all over the world at speed and scale.

This role leads the upstream cell culture manufacturing operations organisation to deliver production activities and meet the required production schedule, playing a pivotal role in the manufacture of our biologics-based medicines. It supports the development of the site, providing technical leadership and support to operations to deliver successful GMP manufacturing.

What you will do:

Collaborate as a member of the Site Leadership Team to develop and deliver on site and organizational priorities and strategy. Role reports to Plant Manager / Site Head.Provide leadership in drug substance manufacturing for commercial manufacturing and new product introductions.Collaborate with cross-functional teams to ensure smooth technology transfers and successful commercial approval.Manage and develop operations team personnel to become strong and empowered leaders.Provide coaching and mentoring to individuals, helping them reach their full potential.Foster a culture of continuous learning and improvement within the operations team.Lead or support various site functional and cross-functional tier structures to drive collaboration and alignment across different departments. Responsible for full Integrated Process Team deliverables, in addition to line Manufacturing organisation.Resolve resource constraints and support resource needs and changes to ensure smooth operations.Drive operational and technical excellence to achieve stability and efficiency in production.Utilize Lean and Six Sigma principles and deploy operational excellence tools to optimize manufacturing processes.Identify process improvement opportunities and implement necessary changes.Comply with the Manufacturing Division Quality Management System (QMS) requirements.Take ownership of relevant quality topics and support the quality risk management process.Ensure permanent inspection readiness in the respective area and drive inspection efforts and results.Manage financial forecasts and workload to achieve departmental headcount and cost improvements.Ensure alignment with capital and expense targets.Contribute to sustainability targets and cost reduction initiatives.Drive and progress the adoption of digital tools across the facility to improve operational efficiency and decision-making.Stay updated on emerging digital technologies and trends that are and can be integrated into the manufacturing processes.Take accountability for delivering on-site Key Performance Indicators (KPIs) in a timely manner.Monitor and ensure achievement of targets related to hiring, uptime, training, change controls, investigations, CAPAs, yield, volume, production cadence, operational availability, and more.Continuously track and improve performance metrics.

Preferred Qualifications and Experience

The following are preferred skills, qualifications, and experiences for the position, and with an interest to learn and grow in the areas with less expertise:

Strong Leadership and Communication Skills: Ability to lead cross-functional teams (including leading managers of managers), foster a high-performance culture, work inclusively while leveraging diverse teams, and effectively communicate with stakeholders.Operational Excellence Focus for Continuous Improvement: Commitment to operational excellence in the production area and for personal and professional growth in the team.  Cultivates a culture of continuous improvement within the team. May have experience with Lean, Six Sigma, and other Operational Excellence tools.Cross-functional Team Leadership: Skilled in leading teams for identifying and implementing effective solutions to complex issues, with a strong track record in decision-making in manufacturing environment. Leads cross-functionally with direct and indirect responsibility.Influencing and Relationship Building: Expertise in building partnerships across various peers and partners to collaborate, drive alignment and achieve key outcomes.Technical competencies: Proven capabilities in site manufacturing and technical operations leadership. Familiar with Operational Excellence, Six Sigma, Lean Methodologies, and project management. Additionally, knowledge and experience in DS biologics manufacturing, particularly in upstream cell culture processes.Regulatory knowledge: Knowledge of global and company health authority regulations and applicable systems and GMP requirements for large molecule manufacturing. They should also have experience engaging with regulatory agencies, including on-site inspections.

Minimum Education and Experience:

• Degree qualification or equivalent in Engineering, Science, Technical or other relevant studies.

• At least 8 years of demonstrated leadership experience in a cross-functional environment, including indirect or direct people management experience.

• Demonstrated experience in biotech, vaccines, or pharma manufacturing site, project, or other relevant experience.

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.

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.

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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:

Not Applicable

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

02/6/2025

*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.

Requisition ID:R332681