Launch Readiness Lead (AD Ops)

Job Description

An exciting opportunity has arisen for a Launch Readiness Lead (AD Ops) for Biologics clinical and commercial manufacturing at our single-use, multi-product commercialization facility in Dunboyne.

The Launch Readiness Lead (LRL) serves as the primary accountable individual for overseeing all aspects of new product introduction and launch readiness for biological products at Dunboyne, including multi-product, operational, and capital project activities where required. Responsible for making tactical and strategic decisions to achieve site and global business goals related to cost, resources, timing, quality, and safety, the LRL leads local capital projects and ensures excellence in execution and financial control. As a member of the Site Leadership Team and part of the global Network Launch Readiness organisation, the LRL collaborates and shares best practices with peers across products and sites, supporting Launch Excellence Leaders to drive improvements. The role reports directly to Site Lead, with a dotted line to the Head of Global Biologics Network Launch Readiness.

Our facility in Dunboyne joined our network in September 2020. Our Dunboyne site is our Company’s first Biologics Drug Substance Single Use Commercialisation Facility, playing a significant role in helping to commercialise key medicines. The innovation and collaboration between our Company’s research and manufacturing teams will significantly accelerate the time it takes to bring a medicine to market for the benefit of patients around the world.

Key responsibilities

• Drive all required site and above-site activities to successfully deliver operational launch milestones and the filing and launch of one or more products in time.

• Define and successfully deliver a related capital project, meeting timeline, cost, quality, and safety expectations.

• Develop local implementation strategies and plan, monitor and co-ordinate the activities of multiple cross-functional local teams including analytical sciences, capital project management, finance, process engineering, scheduling, tech transfer, validation, regulatory filing, managed services, and SMEs to deliver on the activities needed to support launch readiness.

• Effectively communicate and align with all global and local stakeholders and the technology transfer core team.

• Represent the launch readiness activities and if needed the multi-product readiness, operational readiness and capital project activities in the respective Site Leadership Team, site New Product Introduction council, the Global Biologics Governance meetings, and in any required escalation or issue-resolution meetings.

• Consistently apply best practices for launch readiness, developed by the launch excellence initiatives and share lessons learned within the Launch Readiness Operations group.

• Generate and maintain a holistic schedule with resource loading for the launch readiness activities using established standard planning blocks.

Your profile

• Demonstrated leadership with at least 5 years of experience, leading in a cross-functional environment.

• Bachelor’s degree required, ideally in a technical discipline related to pharmaceutical process development or manufacturing.

• Exceptional leadership and people skills for managing through influence.

• Strong stakeholder management abilities to foster networks for project success.

• Strong ownership, sense of urgency and willingness to escalate and proactively resolve issues.

• Robust financial acumen paired with innovative thinking and decision-making skills.

• Proven capacity to lead and collaborate within cross-functional teams, focussed on finding the optimal solution for the entire organisation.

• Proficient in influencing various organizational levels and external partners.

• Ability to quickly grasp complex business and technical issues to mitigate risks.

• Excellent communication skills with a commitment to excellence in execution.

• Strong performance management skills, ensuring accountability for results.

• Good at motivating individuals and teams.

• Experienced in identifying and developing talent.

• Proven expertise in engineering and project management in biologics manufacturing.

• Familiarity with global health regulations and EHS requirements in multiple contexts

• Considerable experience and critical skills in their area of expertise that add value to the business; ideally in manufacturing and commercialisation, preferably GMP setting.

• Deep knowledge and experience in aseptic processing, drug substance and/or drug product manufacturing, formulation and filling of biologics is required.

• Experience in process technology transfers and process validation is essential.

• Experience in project management or product commercialization is desired.

• Knowledge of cGMP and GDP preferred.

• Report, standards, policy writing skills required.

• Proficiency in Microsoft Office and job-related computer applications required.

• Lean Six Sigma Methodology experience desired.

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.

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.

Required Skills:

Preferred Skills:

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.

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