Manufacturing Operations and Engineering Associate Director

Job Description

An exciting opportunity has arisen for a Manufacturing Operations and Engineering Associate Director (Upstream) for the manufacturing hub at our Dunboyne site. The successful candidate will support the development of the site by leading/participating in cross functional teams to deliver all project milestone, supply, and commercialisation activities with a safety first, quality always mindset. As part of the team, drive compliance direction for the site by ensuring adherence to divisional policies and guidelines as well as regulatory requirements.

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

• Lead, coach, support and develop a highly qualified technical support team within the manufacturing Upstream IPT’s
• Drive the team's performance so that every individual understands their individual contribution and how it impacts the site.
• Responsible for Technical Planning and decision-making during facility ramp up and sustaining operation.
• Responsible for leading the area cadence/capacity improvement programs as a key enabler for the Dunboyne commercialisation mission within Global Biologics operations.
• Lead Transformational improvements programs for the site including performance report out to the site SLT in the areas of compliance, delivery, and cost.
• Consistently deliver on key performance metrics, e.g., Environment, Health and Safety metrics, Compliance, Delivery, and budget performance.
• Accountable for Change Control and Deviation Management within the manufacturing area.
• Management of the impact of changes whether through Raw Materials, Automation Recipes, MES systems and Processing Issues, etc. to assure achievement of functional metrics.
• Responsible for driving a culture of Continuous Improvement by deploying the MPS culture and toolkit.
• Seamless collaboration with all groups across the site and network, foster technical excellence to be a differentiating advantage for the Dunboyne commercialisation mission and our operating principles.
• Participate and comply with the internal Quality Management Systems, Environment, Health, and Safety System requirements.
• Demonstrated leadership and change management skills with a continuous improvement focus.
• Proven track record of delivering high performance through development and coaching of a team.
• Manage, coach, and mentor the Manufacturing Tech Support team.
• Build diverse talent with the capabilities necessary to succeed in commercial manufacture. Inspire, reward, and develop individuals, helping them to reach their potential.
• Lead and/or support various site functional and cross functional tier structures.
• Drive operational excellence to deliver all components of a stable process for all commercialisation milestones including pre-clinical, clinical PPQ and commercial supply.
• Responsible for the generation and approval of GMP documentation to support compliance and regulatory expectations for manufacturing operations: change control management and implementation, closure of significant technical investigations, process improvement opportunity identification through implementation, regulatory license section authoring through response-to-questions, health authority inspection SME support, and more.
• Be an advocate of continuous improvement in yield, cycle time, error reduction etc.
• Identify and actively participate in major compliance initiatives to improve compliance status and overall operational efficiency of the site.
• Resolve issues and identify risks in a timely fashion. Ensure project milestones are achieved through planning and execution of integrated overall program schedule.
• Resolve resource constraints and support resource needs and changes.

What skills you will need:

• Bachelor’s degree (or higher) in Chemistry, Biology, Microbiology, Engineering or in a relevant discipline.
• At least 8 years’ experience in the pharmaceutical industry (preferably experience in Large Molecule Drug Substance)
• Knowledge and experience in process optimization, capacity optimisation, technical transfer of products and extensive knowledge of Validation requirements.
• Knowledge of and experience in applying Six Sigma and Lean methodologies
• Desirable evidence of Continuous Professional Development
• Experience with new product introduction and tech. transfer would be advantageous.
• Experience with site operations projects, from capital project to continuous manufacturing operations.
• Experience with regulatory filings and health authority inspections

General competencies:

• Strong collaboration and cross-functional leadership skills to drive continuous improvement and promote knowledge sharing and implementation of best practices across the site.
• Proven ability to effectively initiate and drive change across the site.
• Strong verbal and written communication skills, project management skills.
• Demonstrated ability to influence areas not under direct control to achieve objectives and effectively communicate challenging goals and objectives.
• Demonstrated ability to make and act on decisions while balancing speed, quality, and risk.

Technical:

• Knowledge of US and European GMP guidelines, ICH, and other international regulatory requirements, as applicable to the site.
• Proven capabilities and deep knowledge of design and operation of biologics upstream and downstream startup and manufacturing.
• Strong understanding of project implementation strategy, including experience on regulatory, validation and process technology transfer.
• Knowledge of and practical experience in applying Six Sigma and Lean methodologies.
• Sound judgment and comfortable operating in a challenging, fast-paced, and sometimes ambiguous environment.

As a company, we are committed to ‘Inventing for Life’ in all that we do. 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 apply HERE

Current Contingent Workers apply HERE

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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:

10/1/2024

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