Assoc. Director, Drug Substance Commercialisation

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  • Tipperary
  • Permanent
  • Full-time
  • 17 days ago
Job DescriptionWe have an exciting opportunity for an Assoc. Director, Drug Substance Commercialisation for our site in Ballydine, Co. Tipperary. The successful candidate will manage the provision of technical support for the introduction and production of clinical and commercial active pharmaceutical ingredients (APIs). You will lead process development and scale-up activities, drive process improvements, and provide technical expertise to resolve significant processing issues. This role combines hands-on technical leadership with people and project management responsibilities to ensure safe, compliant, and efficient production.Our Ballydine site is the primary commercialisation facility within the network and the hub where new processes are scaled and brought to commercial manufacture. This site supports the introduction and production of clinical and commercial APIs and the transfer of processes and technologies across internal sites and external partners.Key ResponsibilitiesCore Competencies
  • As a member of the Commercialisation Leadership Team, you are responsible for strategy development and implementation.
  • Lead technical support for commercialisation activities across clinical and commercial production, including multiple processes and process steps.
  • Oversee evaluation of raw materials, process fits, optimisation of chemical API routes, and development for scale-up.
  • Approval of campaign preparation and follow-ups, safety and environmental reviews, batch record reviews, and ensure regulatory and validation compliance.
  • Conduct process monitoring and time cycle analysis, lead deviation investigations and resolution, and define cleaning processes.
  • Provide process leadership to production campaigns (pre-PPQ and commercial).
  • Direct chemistry and engineering support for process development activities for new clinical processes and beyond; evaluate scale-up implications on plant operations, safety, and environment.
  • Manage transfers of processes to other company sites or external partners as required.
  • Ensure laboratory and operational activities are conducted safely and in compliance with current GMP and GLP requirements.
  • Develop and coach team members—delegate appropriately, create growth opportunities, and provide technical, business, and performance guidance.
  • Participate in departmental administration as part of the Technical Leadership Team, including workforce and resource planning, R&D tax reporting, and budget oversight.
  • Contribute to recruitment, development, and assessment programs and support implementation of site human resources and organizational development plans.
  • Ensure assigned processes and systems comply with site, divisional, and corporate quality standards and provide technical support for internal and external audits and submissions.
Functional Leadership
  • Deep technical and subject matter expertise in process development and commercialisation.
  • Solid understanding of new product development and commercialisation, including CMC (Chemistry, Manufacturing & Controls) considerations.
  • Ability to analyse multiple data sources and influence program decisions based on facts.
  • Proactively identify and escalate risks, drive solutions.
  • Translate priorities into actionable plans and hold teams accountable for delivery.
  • Monitor progress to ensure deliverables meet agreed standards and methodologies.
  • Contribute proactively to technical reviews and allocate resources to meet program goals.
  • Understand connectivity across clinical development, CMC, and supply chain to enable successful product launch and stable supply.
  • Communicate effectively to build trust, provide coaching, and develop high-performing teams.
  • Encourage innovative problem solving and alternative approaches to achieve results.
Your profile
  • Degree (BSc/BEng) or higher in Chemistry or Chemical Engineering.
  • Strong background in process chemistry and engineering principles.
  • Experience with process, equipment, and cleaning validation.
  • Knowledge of cGMPs and production operations.
  • Familiarity with electronic batch records and control systems (e.g., DeltaV).
  • Experience with deviation management systems and regulatory requirements.
  • Financial management and budget awareness.
  • Knowledge of HR, training, process safety management, and environmental policies and procedures.
  • Excellent written and verbal presentation skills.
  • Strong teamwork and cross-functional collaboration abilities.
  • Performance management, strategic thinking, project management, problem solving, and lean leadership experience.
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 talented and committed people together. The fastest way to breakthrough innovation is when 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.Required Skills: Accountability, Accountability, API Manufacturing, Change Control Systems, Chemical Process Development, Clinical Development, Clinical Trials, Corporate Productions, Cross-Cultural Awareness, Cross-Functional Teamwork, Delegation of Authority, Environmental Research, Equipment Qualification, GMP Compliance, Leadership, Management Process, Manufacturing Process Validation, People Leadership, Process Chemistry, Process Improvements, Process Optimization, Production Process Development, Production Support, Regulatory Compliance, Regulatory Inspections {+ 4 more}Preferred Skills:Current Employees applyCurrent Contingent Workers applySearch 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: RegularRelocation:VISA Sponsorship:Travel Requirements:Flexible Work Arrangements: HybridShift:Valid Driving License:Hazardous Material(s):Job Posting End Date: 04/20/2026*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.

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