Senior Mass Spectrometry Specialist – Analytical R&D
Location: Swords, Co.Dublin, Ireland
ABOUT US
SK pharmteco is a global Contract Development and Manufacturing organisation (CDMO) with state‑of‑the‑art facilities in Korea, US, France and Ireland. We are part of SK Inc., a Korea company with revenues of $99 billion in 2023. Our mission is to ‘produce and deliver life‑changing therapies that improve patient outcomes and save lives’. The SK pharmteco Small Molecule, Europe, facility located in Swords, Co Dublin, Ireland has led the way in the development, scale‑up and commercial manufacture of Active Pharmaceutical Ingredients (APIs) and Chemical Intermediates for over 60 years. With a talented workforce, exceptional technical capabilities and facilities we have made some of the world’s most important medicines and continue to do so.
CURRENT NEED
We are seeking a highly experienced and technically proficient Senior Mass Spectrometry Analyst to join our Analytical R&D team on a permanent basis. The role is central to supporting drug development through advanced GC‑MS, LC‑MS/MS and HRMS techniques, contributing to method development, structure elucidation, impurity profiling and regulatory submissions. The successful candidate will deliver high‑quality analytical support for early and late phase development, GMP manufacturing and customer‑driven projects.
This position is located at the R&D Centre in Swords, Co Dublin.
POSITION DESCRIPTION
The Senior Mass Spectrometry Analyst will oversee all mass‑spectrometry activities in the R&D group, provide technical support, develop methods for new products and maintain instruments. They will collaborate with Process R&D, Technology Transfer, QA/QC, SHE and external stakeholders, and provide mentorship to junior staff.
KEY RESPONSIBILITIES
Lead the development, optimisation and validation of GC‑MS, LC‑MS, LC‑MS/MS and LC‑HRMS methods for small molecule and peptide analysis using Waters and Agilent instrumentation.
Develop, optimise and validate robust LC‑MS and LC‑MS/MS methods for:
Characterisation and quantification of APIs, RSMs and peptides
Detection of impurities and degradation products
Structural elucidation and mass confirmation
Sequence confirmation
Purity and identity testing
Post‑translational modification (PTM) profiling
Support characterisation of small molecules, peptides and complex formulations.
Perform structural elucidation, impurity profiling and impurity identification using high‑resolution MS and tandem MS techniques.
Provide technical leadership in troubleshooting, data interpretation and mentoring junior analysts.
Interpret complex MS data and prepare technical reports, presentations and regulatory documentation.
Perform instrument troubleshooting, calibration and maintenance.
Collaborate with cross‑functional teams (Process R&D, QA/QC, SHE and external stakeholders).
Prepare detailed documentation: protocols, SOPs, validation reports, analytical method transfer documents and technical reports for customer submissions.
Author and review technical reports, validation protocols and reports.
Ensure compliance with GMP and regulatory guidelines (FDA, EMA, ICH).
Maintain and optimise Waters and Agilent MS systems and associated software (e.g. UNIFI, OpenLab, Empower, MassHunter).
Act as a subject matter expert (SME) in LC‑MS and present at scientific forums.
Evaluate and implement new technologies and workflows to enhance analytical capabilities.
Perform analytical testing in a timely manner to meet project deadlines.
Prepare, review and execute analytical method development and validation protocols and reports.
Ensure all documentation is completed to the required standard, right first‑time, in compliance with local procedures and in a timely manner.
Ensure all instrumentation is within calibration and correctly maintained.
Ensure training is completed before task execution.
Attend weekly team meetings and promote high performance, innovation, continuous improvement and idea sharing.
Meet with manager to discuss performance, provide feedback and identify development opportunities.
Ensure GMP compliance of laboratory operations and documentation.
Ensure a safe work environment for everyone.
Maintain high standards of housekeeping in the laboratory.
KEY SKILLS AND QUALIFICATIONS
MSc/PhD in Analytical Chemistry, Pharmaceutical Sciences, Biochemistry or a related field.
Minimum 5 years of hands‑on experience in mass‑spectrometry for small molecule analysis in a CDMO, pharmaceutical or biotech setting.
Proven experience with small molecules, peptides and complex raw materials.
Familiarity with regulatory guidelines (ICH, FDA, EMA) related to API and peptide development.
Extensive hands‑on experience with MS systems in a pharmaceutical R&D or QC setting, ideally with both Waters and Agilent GC‑MS, LC‑MS, LC‑MS/MS and LC‑HRMS platforms and software tools.
Knowledge of peptide mapping, bioanalytical techniques or oligonucleotide analysis.
Strong understanding of chromatographic techniques, sample preparation and method validation principles.
Familiarity with QbD principles and statistical tools (e.g. JMP, Minitab).
Experience with forced degradation studies, impurity qualification and identification workflows.
Knowledge of automation and high‑throughput MS workflows using Waters and Agilent systems.
Demonstrable expertise in developing analytical methods, particularly for HPLC and GC.
Track record of contributing to regulatory submissions and cross‑functional project teams.
Excellent problem‑solving, communication and scientific writing skills.
Strong technical background in chemistry, particularly analytical chemistry.
Strong analytical thinking, troubleshooting ability and attention to detail.
Ability to work to tight timelines.
Openness to change and receptiveness to new ideas.
Knowledge of FDA and European GMP requirements for laboratory operations.
OTHER BENEFITS INCLUDE
Excellent opportunities for career enhancement and personal development.
Annual bonus linked to business results.
A well‑established further education programme.
#J-18808-Ljbffr