Manager, Analytical R&D

Job Summary

The Mass Spectrometry Group Manager leads the staff and operations within Analytical Development responsible for all mass‑spectrometry–based studies, special investigations, and analytical support for new product development, global regulatory submissions and commercial products. This role oversees all LC‑MS and GC-MS projects and testing activities, ensuring scientific excellence, regulatory compliance, and alignment with project and organizational goals.

The manager provides technical leadership to scientists and senior chemists in developing and validating new LC‑MS and GC-MS methods for pharmaceutical analysis. They guide the team in conducting complex investigations, including structural elucidation and identification of related substances and degradation products in drug substances and drug products.

Acting as a site-wide and cross‑functional expert, the Mass Spectrometry Group Manager consults with other departments and affiliated organizations on MS-related challenges, offering strategic problem‑solving and advanced technical insight to support quality, development, and regulatory needs.

Job Responsibilities

• Serve as an expert technical specialist within the Product Development organization, providing advanced scientific leadership in mass spectrometry.
• Guide scientific leader, directing them in development, implementation, and application of complex MS methodologies to support product development and regulatory requirements.
• Lead all mass spectrometry projects and investigations within Analytical Development (AD), ensuring scientific rigor, compliance, and timely execution.
• Function as an internal subject matter expert, offering technical consultation and project support, including oversight of external research and service providers.
• Recommend the selection and engagement of external partners for mass spectrometry–related research or analytical services.
• Manage across analytical research and development team to develop and execute strategies that resolve complex technical challenges in identification and peptide development.
• Leads organization at scientific forums, conferences, and professional associations as an authority in mass spectrometry and peptide development.
• Guide scientist to design and develop MS‑compatible LC / GC methods and perform LC/GC/MS and LC/GC/MS/MS analysis for drug substances and drug products, including nitrosamine impurities, genotoxic impurities, peptides, and other critical analytes.
• Guide scientists to conduct structural elucidation and identification of unknown impurities using MS/MS data, scientific literature, and other analytical tools.
• Approve comprehensive structure‑elucidation and investigation reports based on mass spectrometry and supporting analytical data.
• Design, implement, and maintain LC/MS and GC/MS system qualification procedures, including maintenance, operational qualification (OQ), and performance qualification (PQ) in alignment with manufacturer requirements.
• Provide technical guidance, training, and mentorship to scientists and team members to strengthen organizational MS capability.
• Work collaboratively within cross‑functional teams, contributing to shared goals and fostering a positive, productive work environment.
• Maintain strict adherence to all compliance requirements, including Global Business Ethics and Compliance, Global Quality policies, Safety and Environment standards, and HR policies.
• Always ensure all employees work safely and actively contribute to a culture of safety and continuous improvement.
• Recruit, train, develop and manage effectively the ongoing performance of their direct reports, which includes, but is not limited to:

• • Ensuring their Job Descriptions are reviewed, signed and sent to Employee Services, annually,
  • Reviewing and updating employee development plans, ensuring that all employees are properly trained and qualified to execute their duties,
  • All other duties as assigned.

Job Requirements

Education: 

• Master’s or Ph.D. in scientific discipline, especially Organic Chemistry or Analytic Chemistry or pharmaceutical sciences.

Knowledge, Skills and Abilities:

• Strong theoretical background in analytical chemistry and organic chemistry paired with an expert knowledge of mass spectroscopy and chromatography.
• In-depth knowledge of analytical method development and validation.
• Advance knowledge of peptide analysis by mass spectrometry.
• Advance knowledge of analytical instrumentation including HPLC, LC-MS and GC-MS.
• In depth knowledge of regulatory guidelines (FDA, TPD, ICH etc.)  GMP and GDP
• Excellent communication skills, verbal and written.

• • Leadership and management skills demonstrated in previous supervisory/management roles.