4 days ago Be among the first 25 applicantsGet AI-powered advice on this job and more exclusive features.Direct message the job poster from Morgan McKinleyProcess & Manufacturing Engineering @MMKSenior Biopharmaceutical Engineer (Drug Substance & Drug Product)A number of our client companies are seeking to hire Senior Engineers to join drug substance and sterile fill finish manufacturing teams.In this pivotal role, you'll drive the strategic development and manufacturing of life-changing therapies, contributing significantly to both drug substance and drug product aspects of the biopharmaceutical pipeline.We need a leader who's passionate about pushing the boundaries of bioprocess engineering, thrives on solving complex challenges, and is ready to make a substantial impact in a fast-paced and innovative environment.Key Responsibilities:Lead the design, development, and optimization of cutting-edge upstream and/or downstream processes for biologics manufacturing (e.g., cell culture, fermentation, purification, viral inactivation).Oversee the development and optimization of robust drug product formulations and manufacturing processes (e.g., fill/finish, lyophilization, sterile manufacturing).Drive process characterization, scale-up, and technology transfer initiatives, ensuring successful implementation and commercial readiness.Provide expert guidance in troubleshooting complex manufacturing issues, implementing sustainable and compliant solutions.Ensure rigorous compliance with cGMP regulations, industry best practices, and lead efforts in regulatory interactions.Strategically collaborate with cross-functional leadership teams across R&D, Quality, Manufacturing, and Regulatory Affairs to advance pipeline programs.Mentor and develop junior and mid-level engineers, fostering a culture of technical excellence, innovation, and continuous improvement.Present complex technical data and strategic insights to senior leadership and external partners.Qualifications:Bachelor's, Master's, or Ph.D. in Process & Chemical Engineering, Electrical Engineering, Mechanical Engineering or a related discipline.Extensive experience (typically 10+ years) in the biopharmaceutical industry, with a proven track record of leadership in either drug substance (upstream/downstream) or drug product development and manufacturing.Parenteral experience is highly desirable.Deep expertise in biologics manufacturing principles, advanced unit operations, and sophisticated process control strategies.Comprehensive understanding and experience with cGMP environments and advanced quality systems.Demonstrated ability to strategically resolve highly complex technical and operational challenges.Exceptional leadership, communication, and interpersonal skills, with a proven ability to influence and collaborate across all levels of an organization.Strong analytical acumen and a track record of innovative problem-solving.Preferred Qualifications:Proven expertise with single-use technologies.Significant experience with regulatory submissions.If you are a visionary and highly experienced Biopharmaceutical Engineer ready to lead critical initiatives, we invite you to apply.Seniority levelSeniority levelMid-Senior levelEmployment typeEmployment typeFull-timeJob functionJob functionEngineering and ScienceIndustriesManufacturingReferrals increase your chances of interviewing at Morgan McKinley by 2xGet notified about new Senior Engineer jobs in Dublin, County Dublin, Ireland.Dublin, County Dublin, Ireland 2 months agoDublin, County Dublin, Ireland 4 months agoDublin, County Dublin, Ireland 3 months agoSenior Automation Engineer Team Lead, Assistant Vice PresidentDublin, County Dublin, Ireland 5 hours agoDublin, County Dublin, Ireland 5 days agoDublin, County Dublin, Ireland 1 week agoDublin, County Dublin, Ireland 3 weeks agoDublin, County Dublin, Ireland 2 months agoSENIOR INSTRUMENTATION & CONTROLS ENGINEER - DUBLINDublin, County Dublin, Ireland 5 months agoDublin, County Dublin, Ireland 4 months agoDublin, County Dublin, Ireland 3 days agoDublin, County Dublin, Ireland 5 days agoSenior R&D Engineer - System Architecture (Italy based)Dublin, County Dublin, Ireland 5 months agoDublin, County Dublin, Ireland 3 months agoDublin, County Dublin, Ireland 2 weeks agoDublin, County Dublin, Ireland 18 hours agoDublin, County Dublin, Ireland 5 months agoDublin, County Dublin, Ireland 2 weeks agoDublin, County Dublin, Ireland 1 week agoDublin, County Dublin, Ireland 1 week agoDublin, County Dublin, Ireland 5 days agoDublin, County Dublin, Ireland 2 weeks agoDublin, County Dublin, Ireland 1 week agoDublin, County Dublin, Ireland 1 week agoEngineering Manager, Remediations ExperienceDublin, County Dublin, Ireland 2 weeks agoSenior Manager Engineering & Design ManagementMaynooth, County Kildare, Ireland 2 days agoDublin, County Dublin, Ireland 3 weeks agoDublin, County Dublin, Ireland 1 week agoSenior Facilities Engineer (Manufacturing)Dublin, County Dublin, Ireland 2 months agoDublin, County Dublin, Ireland 3 weeks agoSr Automation Engineer (Technical Team Lead) - FT ContractDublin, County Dublin, Ireland 4 days agoSenior Manager Engineering & Design ManagementMaynooth, County Kildare, Ireland 1 day agoDublin, County Dublin, Ireland 20 hours agoDublin, County Dublin, Ireland 6 days agoDublin, County Dublin, Ireland 6 days agoWe’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr