Associate Principal Scientist, Sterile Drug Product Commercialization - Ireland - Hybrid

Associate Principal Scientist, Sterile Drug Product Commercialization - Ireland - Hybrid page is loaded Associate Principal Scientist, Sterile Drug Product Commercialization - Ireland - Hybrid Apply remote type Hybrid locations IRL - Carlow - Carlow IRL - Tipperary - Ballydine IRL - Dublin - Leopardstown (Red Oak) IRL - Cork - Brinny time type Full time posted on Posted 2 Days Ago job requisition id R288170 Job Description At Our Company, our Sterile Drug Product Commercialization group within the Manufacturing Division is seeking an experienced and innovative Associate Principal Scientist to join our team. We drive the scientific and engineering advancements necessary for the innovative and accelerated commercialization of novel Vaccines, Biologics, and Pharmaceutical products, including combination products. This role will provide end-to-end leadership and accountability for key activities in the Sterile Drug Product Commercialization department, with a focus on process scale up, transfer, and validation. Responsibilities: Lead cross-functional drug product (DP) working groups and manage DP activities including tech transfer, validation, and regulatory submissions. Ensure commercialization programs meet requirements related to science, quality, reliability, schedule, and cost Drive strategic initiatives to enhance efficiency and rapid commercialization of innovative products Provide mentorship, technical oversight, and strategic guidance to employees Develop process and product development plans, including primary packaging and combination product design Design and execute DP development and commercialization studies, process validation, and new product introductions Develop and employ fit-for-purpose scale-down models and establish platform engineering and scientific models for sterile product and process commercialization Drive best practices for tech transfer, facility fit, and DP control strategy Influence CMC regulatory strategy and author/review regulatory submissions Drive process optimization towards standardized platforms for liquid, lyophilized, and combination product presentations Foster a culture of high performance, innovation, learning, diversity, and inclusion Requirements: Bachelor's, Master's, or Ph.D. degree in Chemical Engineering, Biochemical Engineering, Bioengineering, Pharmaceuticals, Biochemistry, Microbiology, or related field 4-10 years of relevant experience depending on education level Technical expertise in sterile drug product fill finish manufacturing processes for large molecules Experience with technology transfer and scale-up of processes Excellent oral and written communication skills Preferred experience includes biologics drug product fill finish optimization, operations experience in manufacturing of sterile drug products, knowledge of combination product development, regulatory requirements for commercialization of sterile drug products, and working knowledge of statistical methods and analytical techniques for manufacturing processes Ability to travel up to 25% of the time This role is connected to an Ireland site with limited need to be office based. Travel is 25% of the role Current Employees apply HERE Current Contingent Workers apply HERE Secondary Language(s) Job Description: 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 . As an equal opportunity employer, we are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. Please don't hesitate to contact the Talent Acquisition Advisor assigned to this role should you need any support during our recruitment process. We are committed to flexible working where possible, and this is why our Company has introduced a new hybrid working model for office-based colleagues around the world . Please feel free to speak to us about what flexibility means to you during your application or click on the link to find out more about our hybrid working model So, if you are ready to: Invent solutions to meet unmet healthcare needs, please apply today. Search 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: Regular Relocation: VISA Sponsorship: Travel Requirements: Flexible Work Arrangements: Hybrid Shift: Valid Driving License: Hazardous Material(s): Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where we have codified our legacy for over a century. Our success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare. #J-18808-Ljbffr