Operations Director, Drug Substance (Upstream)

Job Description

We are excited to announce an opportunity for an Operations Director at our cutting-edge Biotech facility in Dublin. Here, we are dedicated to delivering life-changing medications to patients worldwide.

As a key member of our Site Leadership Team, you will help shape our site and organizational strategies. You will report directly to the Plant Manager/Site Head and play a vital role in our mission in delivering biologics medicines.

Bring energy, knowledge, innovation to carry out the following:

• Leadership in Manufacturing: Guide drug substance manufacturing for commercial production and new product introductions. Collaborate with teams to ensure smooth technology transfers.
• Team Development: Coach and empower operations personnel to become strong leaders. Address resource needs to maintain smooth operations and foster a culture of continuous learning.
• Collaboration and Partnership: Lead site and cross-functional teams to enhance collaboration and alignment across departments. Oversee Integrated Process Team deliverables alongside manufacturing responsibilities.
• Operational Excellence: Drive stability and efficiency in production using Lean and Six Sigma principles. Identify and implement process improvements.
• Quality Management: Ensure compliance with quality management systems, risk processes, and regulatory requirements. Lead inspection efforts and maintain readiness.
• Financial Management: Manage financial forecasts and departmental costs, ensuring alignment with capital and expense plans.
• Digital Transformation: Advocate for the use and implementation of digital tools to improve operational efficiency and stay updated on emerging technologies.
• Performance Accountability: Ensure timely delivery on site strategies (Hoshin Kanri) and key performance indicators, monitoring targets related to hiring, production, and operational availability.

What skills you will need:

In order to excel in this role, you will more than likely have:

• Leadership and Communication: Strong ability to lead cross-functional teams and foster a high-performance culture while effectively communicating with stakeholders.
• Operational Excellence: Commitment to continuous improvement and familiarity with Lean, Six Sigma, and other operational excellence tools.
• Cross-functional Team Leadership: Proven track record in decision-making and leading teams to solve complex issues in a manufacturing environment.
• Influencing and Relationship Building: Expertise in building partnerships to drive collaboration and achieve key outcomes.
• Technical Competencies: Experience in manufacturing and technical operations leadership, particularly in upstream cell culture processes.
• Regulatory Knowledge: Understanding of global health authority regulations and good manufacturing practices for large molecule manufacturing, with experience engaging with regulatory agencies.

Minimum education and experience:

• A degree in Engineering, Science, Technical, or a related field.
• At least 8 years of leadership experience in a cross-functional environment, including direct or indirect people management.
• Experience in biotech, vaccines, or pharmaceutical manufacturing is preferred.

Current Employees apply HERE

Current Contingent Workers apply HERE

Secondary Language(s) Job Description:

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.

As an equal opportunity employer, we are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. Please don't hesitate to contact the Talent Acquisition Advisor assigned to this role should you need any support during our recruitment process.

We are committed to flexible working where possible, and this is why our Company has introduced a new hybrid working model for office-based colleagues around the world.

Please feel free to speak to us about what flexibility means to you during your application.

So, if you are ready to:

Invent solutions to meet unmet healthcare needs, please apply today.

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:

Domestic/International

VISA Sponsorship:

Yes

Travel Requirements:

10%

Flexible Work Arrangements:

Not Applicable

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

N/A

Job Posting End Date:

05/21/2025

*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.