Job Description
Join our team in Dundalk as a Drug Product Specialist, MS&T. This role will report to the Manufacturing, Science and Technology (MS&T) Drug Product Lead.
The position will suit a self-starter who is results-focused with the ability to work independently and on multidisciplinary teams.
Bring Energy, Knowledge, Innovation To Carry Out The Following
* Execute the Tech Transfer and commercialization of our Company products including: Development batches, PPQ campaign, data close out and analysis, and licence application. Support establishment of the commercial process, routine manufacturing, and future product tech transfers by:
* Build, develop, and grow the Drug Product MS&T team and the individuals within while also providing technical guidance.
* Problem solving within the site Integrated Production Team (IPT) structures and escalating to the DP MS&T Lead at the appropriate times.
* Support experimental design, execution, data analysis and interpretation.
* Interpret trends observed in commercial process monitoring (e.g., proactive process analysis (PPA), continued process verification (CPV), statistical process control (SPC) multivariate analyses (MVDA)), and for further technical investigations and process changes that seek to drive improvements to yield and/or robustness.
* Support deviation management and timely closure against site metrics.
* Support change control prioritization and implementation and compliant closure.
* Author and review batch documentation, technical reports, and global regulatory submissions.
* Support multidisciplinary teams (e.g. Manufacturing Science and Technology, Quality, Analytics, Regulatory) for process improvement and troubleshooting with end-to-end product focus.
* Serve as a key member during internal audits and external inspections/audits.
* Lead and support various site and manufacturing science and technology organizational initiatives as needed (examples include safety, financial forecasting, work standardization, etc).
What Skills You Will Need
In order to excel in this role, you will more than likely have:
* Expertise in therapeutic manufacturing support: Formulation; sterile boundaries; Filtration (Tangential & normal flow); filling and freezing; lyophilisation.
* Experience with technology transfer, regulatory filing, and commercial manufacture of biologics/vaccines is a plus.
* Technical operations experience in the manufacture of therapeutics at the pilot- and/or commercial-scale.
* Prior involvement in process development, process characterisation studies, process performance qualification and validation, site readiness, batch record reviews, authoring regulatory CTD sections and/or working with external contract organisation for development and/or manufacturing.
* Working knowledge of statistical methods for DOE design and data analysis (e.g., JMP or Design Expert software)
* Working familiarity of statistical process control (SPC), multivariate analysis (MVDA), and/or process analytical technologies (PAT) techniques for therapeutic processes
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.
So, If You Are Ready To
Invent solutions to meet unmet healthcare needs, please apply today.
Current Employees apply HERE
Current Contingent Workers apply HERE
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
Not Applicable
Shift
Valid Driving License:
Hazardous Material(s)
Required Skills:
Accountability, Adaptability, Analytical Tools, Applied Mathematics, Chemical Engineering, Construction Cost Estimating, Data Analysis, Data-Driven Decision Making, Engineering Standards, Estimation and Planning, Manufacturing Processes, Manufacturing Quality Control, Multivariate Data Analysis, Process Improvements, Process Research, Product Development, Product Formulation, Production Process Development, Regulatory Requirements, Risk Analysis, Risk Assessments, Statistical Process Control (SPC), Technical Problem-Solving
Preferred Skills
Job Posting End Date:
07/1/2025
* 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.
Requisition ID:R354235 #J-18808-Ljbffr