Senior Specialist Process Sciences, MS&T
Join to apply for the Senior Specialist Process Sciences, MS&T role at MSD Ireland
Senior Specialist Process Sciences, MS&T
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Join to apply for the Senior Specialist Process Sciences, MS&T role at MSD Ireland
Job Description
Join our team in Dundalk as a
Job Description
Join our team in Dundalk as a Senior Specialist Process Sciences, MS&T. This role supports the MS&T process sciences laboratory team and ensures that MS&T team objectives are effectively achieved, consistent with our requirements to ensure compliance, safety and reliable supply to our customers.
Bring Energy, Knowledge, Innovation To Carry Out The Following
* Support and execute experimental design, data analysis and interpretation to resolve complex cell culture and / or downstream deviations.
* Support the process sciences team during small scale model run execution, including media & buffer preparation make up, equipment set up, run execution, sampling and data analysis.
* Author and review standard operating procedures, study protocols and reports as required.
* Support global regulatory submissions as needed.
* Support multidisciplinary teams (MS&T, quality, analytics, regulatory) for process improvement and troubleshooting.
* Assure effective application of Lean Six Sigma and Change Management tools in the Analytical Sciences group by:
* Secure continuity of an appropriate level of knowledge.
* Facilitate problem solving & risk assessment (FMEA) projects/meeting.
* Make problems visible and striving for continuous improvement.
* Support alignment and knowledge exchange with development organizations, other commercial nodes and external manufacturing partners.
What Skills You Will Need
In order to excel in this role, you will more than likely have:
* Bachelor’s degree (or higher) in in Biological Sciences/Chemistry /Chemical Engineering/Biological Engineering.
* 5 years directly related experience in academia, pharmaceutical or biotechnology company.
* Prior experience in drug substance 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.
* Experience in executing experimental programs in the laboratory.
* Working knowledge of statistical methods for DOE design and data analysis (e.g., JMP or Design Expert software).
* Experience with technology transfer, regulatory filing, and commercial drug substance manufacturing of vaccines is a plus.
* Knowledge of and experience in applying Six Sigma and Lean methodologies
* Desirable evidence of Continuous Professional Development.
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:
Adaptability, Cell Cultures, Data Analysis, Detail-Oriented, Engineering Standards, Estimation and Planning, Immunochemistry, Immunology, Interdisciplinary Collaboration, Interpersonal Relationships, Mammalian Cell Culture, Manufacturing Processes, Manufacturing Quality Control, Microbiology, Process Design, Process Improvements, Project Planning, Regulatory Compliance, Risk Assessments, Root Cause Analysis (RCA), Sample Analysis, Six Sigma, Standard Operating Procedure (SOP), Technical Support, Technology Transfer
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:R354232
Seniority level
* Seniority level
Mid-Senior level
Employment type
* Employment type
Full-time
Job function
* Job function
Information Technology
* Industries
Pharmaceutical Manufacturing
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