Job Description
An opportunity has arisen for an analytical scientist to join our Supply Analytical Sciences (SAS) team based in Ballydine. The successful candidate will join team as a scientist supporting small molecule drug substance supply in our company and external partner manufacturing sites in Europe.
Travel: Up to 25%
Bring energy, knowledge, innovation to carry out the following:
Support development and transfer of scientifically sound and compliant analytical test methods to meet quality requirements to support release of pharmaceutical materials.Support the optimization and execution of robust and reliable analytical methods to assess the quality attributes of drug substances.Supports the transfer of analytical methods, specifications and development knowledge for the drug substance associated manufacturing process.Assures that right information on the quality of raw materials and in-process control points is provided to support process optimization studies with a clear linkage to regulatory filing requirements.Manages change control for analytical methods and specifications for assuring the quality of drug substances for inclusion in the regulatory submissions.Provides the analytical information for filings and responses to questions from regulatory agencies.Executes laboratory work to characterize extraneous matter using SEM/EDX, microscopy and FTIR techniques in support of GMP investigations.Establishes relationships with partner scientific groups that facilitate a clear understanding of analytical issues and product supply.In partnership with the Quality organization, formulates and continually updates appropriate GMP procedures for analytical methods.Work with teams of scientists to effectively coordinate and support analytical method execution in a compliant manner.What skills you will need:
In order to excel in this role, you will more than likely have:
Qualification (BSc, MSc) in science with experience of analytical chemistry techniques. Effective communication skills and ability to work as part of cross functional team.Outstanding critical thinking skills.Ability to work in an interdisciplinary team environment.Strong verbal and written communication skills.Experience in small molecule analytical development or quality control analytical testing,BSc minimum 3 years of experienceMSc minimum 2 years of experienceExperience in analytical technology transfers.Characterization of extraneous matter particlesWe 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:
RegularRelocation:
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
HybridShift:
Valid Driving License:
Hazardous Material(s):
Required Skills:
Adaptability, Adaptability, Analytical Chemistry, Analytical Instrumentation, Analytical Method Development, Analytical Problem Solving, Analytical Testing, Antibody Drug Conjugates (ADC), Bioanalysis, Business, Chemistry Techniques, Communication, Critical Thinking, Detail-Oriented, GMP Compliance, Laboratory Safety, Liquid Chromatography-Mass Spectrometry (LC-MS), Manufacturing Processes, Organic Synthesis, Preparative Chromatography, Process Manufacturing, Process Optimization, Purification Methods, Raw Materials, Raw Material Testing {+ 5 more}Preferred Skills:
Job Posting End Date:
05/31/2025*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:R349932