Senior Mass Spectrometry Specialist – Analytical R&D

Cpl Group View all jobs

  • Dublin
  • Permanent
  • Full-time
  • 24 days ago
Senior Mass Spectrometry Specialist - Analytical R&DLocation: Swords, Co.Dublin, IrelandABOUT 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. Further information on SK pharmteco can be found at www.skpharmteco.comCURRENT NEED:We are seeking to recruit a highly experienced and technically proficient Senior Mass Spectrometry Analyst to join our Analytical R&D team on a permanent basis to lead analytical efforts focused on small molecule characterization and quantification using Waters and Agilent mass spectrometry platforms. This 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 play a key role in delivering high-quality analytical support for both early and late phase development, GMP manufacturing, and customer driven projects.This position is located at the R&D Centre in Swords, Co Dublin. The R&D Centre has co-located technical and operational expertise, including analytical expertise that supports the development and manufacture of clinical and commercial products (small molecule APIs, intermediates, RSMs and peptides).POSITION DESCRIPTION:The Senior Mass Spectrometry Analyst will be responsible for taking oversight of all mass spectrometry activities in the R&D group, and providing technical support for these activities, as well as developing mass spectrometry methods to support method introduction for new products. In addition, the successful candidate will provide technical support for all aspects of mass spectrometry analysis including method transfer, method qualification and method troubleshooting pertaining to the manufacture of small molecule APIs, intermediates RSMs and peptides. The successful candidate will also provide support in the day-to-day running and maintenance of mass spectrometry instruments in the AR&D laboratories. The successful candidate will need to collaborate closely with other functions, including Process R&D, Technology transfer, Quality (QA/QC), SHE and external stakeholders/customers working towards the flawless, compliant and right first-time manufacture of existing and new products. In addition, the successful candidate will provide mentorship, where applicable, to more junior analytical staff.KEY RESPONSBILITIES:
  • Lead the development, optimization, and validation of GC-MS, LC-MS, LC-MS/MS and LC-HRMS methods for small molecule and peptide analysis using Waters (e.g., QDa, Xevo G2S) and Agilent (e.g., 5977B, Ultivo) instrumentation.
  • Develop, optimize, and validate robust LC-MS and LC-MS/MS methods for:
  • Characterization and quantification of APIs, RSMs, and peptides
  • Detection of impurities and degradation products
  • Structural elucidation and mass confirmation
  • Support characterization of small molecules, peptides, and complex formulations.
  • Support peptide characterization including:
  • Sequence confirmation
  • Purity and identity testing
  • Post-translational modification (PTM) profiling
  • 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 (e.g., QQQ, QTOF, Orbitrap, or equivalent platforms from Waters, or Agilent).
  • Interpret complex MS data and collaborate with cross-functional teams to ensure data-driven decisions.
  • Prepare detailed documentation: protocols, SOPs, validation reports, analytical method transfer documents, and technical reports for customer submissions.
  • Collaborate with cross-functional teams including Process R&D, Quality (QA/QC), SHE and external stakeholders/customers.
  • Author and review technical reports, validation protocols and reports.
  • Ensure compliance with GMP and regulatory guidelines (FDA, EMA, ICH).
  • Maintain and optimize Waters and Agilent MS systems and associated software (e.g. UNIFI, OpenLab, Empower, MassHunter etc.).
  • Troubleshoot instrumentation and ensure optimal performance.
  • Act as a subject matter expert (SME) in LC-MS for internal and external stakeholders.
  • Attend and present at scientific forums as SME in LC-MS.
  • Evaluate and implement new technologies and workflows to enhance analytical capabilities.
  • Perform analytical testing in a timely manner for analytical testing, validation, and qualification, where appropriate, to ensure project deadlines are achieved.
  • Prepare and review analytical method development reports.
  • Prepare, review, and execute analytical validation protocols.
  • Prepare and review analytical validation 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 used is within calibration and is correctly maintained.
  • Ensure training is completed before execution of a task.
  • Attend weekly team meetings and participate in a culture, which is committed to high performance, innovation, and continuous improvement and promotes idea sharing.
  • Meet with manager to discuss performance, provide feedback and identify any development opportunities.
  • Ensure GMP Compliance of laboratory operations and documentation, including testing, write ups, review and approval of protocols, reports and change controls.
  • Ensure a safe work environment for oneself and all employees.
  • Ensure high standards of housekeeping are maintained in the laboratory.
KEY SKILLS AND QUALIFICATIONS:
  • MSc/PhD in Analytical Chemistry, Pharmaceutical Sciences, Biochemistry, or 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 working 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 experience 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 impurity 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.
  • Proven track record of contributing to regulatory submissions and cross-functional project teams.
  • Excellent problem-solving, communication, and scientific writing skills.
  • Excellent core competencies such as teamwork, communication skills, and technical 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.
  • Good Troubleshooting skills.
  • Openness to change, receptiveness to new ideas.
  • Knowledge of FDA and European GMPs requirements, particularly pertaining to laboratory operations.
OTHER BENEFITS INCLUDE:
  • Excellent opportunities for career enhancement and personal development
  • Competitive base salary
  • Annual bonus linked to business results
  • A well-established further education program.
  • Pension scheme
  • Private Healthcare

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