Operations Director - Drug Substance (Upstream)

Merck Gruppe - MSD Sharp & Dohme; Swords; On-site; CAD 90,000 - 150,000; Full time

Job summary

An established industry player is seeking an Operations Director to lead the Upstream Cell Culture Biotech Drug Substance team. This pivotal role involves overseeing manufacturing operations, fostering a culture of continuous improvement, and driving digital transformation within a state-of-the-art facility. The ideal candidate will possess strong leadership skills, a commitment to operational excellence, and a deep understanding of biotech processes. Join a team dedicated to delivering life-changing medications and making a significant impact in the healthcare sector. If you are passionate about innovation and collaboration, this opportunity is perfect for you.

Qualifications

• 8+ years of leadership experience in biotech or pharma manufacturing.
• Strong focus on operational excellence and continuous improvement.

Responsibilities

• Lead drug substance manufacturing and new product introductions.
• Drive operational excellence and implement process improvements.

Skills

Leadership Skills

Communication Skills

Operational Excellence

Lean Methodologies

Six Sigma

Project Management

Technical Operations Leadership

Regulatory Knowledge

Education

Degree in Engineering

Degree in Science

Degree in Technical Studies

Tools

Digital Tools

Job description

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.

As a member of the Site Leadership Team, the successful candidate will collaborate to develop and implement site and organisational priorities and strategies. This role reports directly to the Plant Manager/Site Head.

Key Responsibilities:

Leadership in Manufacturing:

1. Provide leadership in drug substance manufacturing for both commercial production and new product introductions.
2. Collaborate with cross-functional teams to ensure smooth technology transfers and successful commercial production.

Team Development:

1. Manage, coach, and develop operations personnel to become strong, empowered leaders.
2. Resolve resource constraints and support resource needs and changes to ensure smooth operations.
3. Foster a culture of continuous learning and improvement within the operations team.

Collaboration and Partnership:

1. Lead or support various site functional and cross-functional tier structures to drive collaboration and alignment across departments and with cross-site network partners.
2. Be responsible for all Integrated Process Team deliverables, in addition to line manufacturing responsibilities.

Operational Excellence:

1. Drive operational and technical excellence to achieve stability and efficiency in production.
2. Utilize Lean and Six Sigma principles, deploying operational excellence tools to optimize manufacturing processes.
3. Identify process improvement opportunities and implement changes to advance the site.

Quality Management:

1. Comply with the Manufacturing Division Quality Management System (QMS) and regulatory requirements.
2. Take ownership of relevant quality topics and support the quality risk management process.
3. Ensure inspection readiness in the respective area and lead inspection efforts and outcomes.

Financial Management:

1. Manage financial forecasts and workload to achieve departmental headcount and cost improvements.
2. Ensure alignment with capital and expense plans.

Digital Transformation:

1. Promote the adoption of digital tools across the facility to enhance operational efficiency and decision-making.
2. Stay informed about emerging digital technologies and trends that can be integrated into manufacturing processes.

Performance Accountability:

1. Take accountability for delivering on site Strategy (Hoshin Kanri) and Key Performance Indicators (KPIs) in a timely manner.
2. Monitor and ensure the achievement of targets related to hiring, uptime, training, change controls, investigations, CAPAs, yield, volume, production cadence, and operational availability.

Preferred Qualifications and Experience:

1. 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.
2. 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.
3. 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.
4. Influencing and Relationship Building: Expertise in building partnerships across various peers and partners to collaborate, drive alignment and achieve key outcomes.
5. 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.
6. 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:

1. Degree qualification or equivalent in Engineering, Science, Technical or other relevant studies.
2. At least 8 years of demonstrated leadership experience in a cross-functional environment, including indirect or direct people management experience.
3. 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.

Current Employees apply HERE

Current Contingent Workers apply HERE

Employee Status: Regular

Job Posting End Date: 04/30/2025

*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