LCMS Analyst / Scientist
Analytical Method Development & Validation by LCMS.
Preparation of Protocols and Reports.
Method Development and Validation by LCMS (nitrosamine)
Develops and validates reproducible and appropriate analytical methods as needed respecting the GMP practices;
Participates in analytical troubleshooting;
Writes methods, validation protocols, validation reports and investigation reports;
Performs analyses;
Participates in drafting SOP/ working instructions.
Required Candidate profile
Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals:
Preferred Qualifications:
If you have the following characteristics, it would be a plus:
- Strong organizational skills
- Excellent interpersonal communication skills
- Excellent technical writing skills
- Ability to work in multi-disciplinary and multi-cultural teams
- Ability to interpret analytical results from experiments to troubleshoot and optimize analytical methods.
Key Responsibilities
Method Development and Validation:
Develop, optimize, and validate LCMS methods for qualitative and quantitative analysis of small molecules tables,capulse.Sample Analysis:
Perform routine and non-routine analyses of raw materials, intermediates, and finished products using LCMS techniques.Data Management:
Acquire, process, and interpret LCMS data; ensure accurate data recording and reporting following laboratory documentation procedures.Instrument Maintenance:
Operate, calibrate, and maintain LCMS systems (e.g., QTOF, Triple Quad, Orbitrap); troubleshoot issues to ensure minimal downtime.Compliance and Quality Assurance:
Follow GLP, GMP, or ISO standards (as applicable); maintain proper documentation of all laboratory activities.Collaboration:
Work closely with cross-functional teams (R&D, QA/QC, Production) to support analytical and product development needs.Continuous Improvement:
Participate in process optimization, new technology evaluation, and laboratory efficiency initiatives.
Qualifications
Education:
Bachelors, Masters, or Ph.D. in Chemistry, Biochemistry, Pharmaceutical Sciences, or a related field.Experience:
- 1 to 5 years or 5+ years (Scientist/Senior) of experience in LCMS analysis.
- Hands-on experience with LCMS instrumentation (e.g., Waters, Agilent, Sciex, Thermo, Bruker)
- Experience with method validation, method development quantitation, and mass spectral interpretation.
- Experienced in analytical method validation and regulatory documentation
.
- Instrumentation (Nitrosamines by LCMS)
Technical Skills:
- Proficient in LCMS data analysis software (e.g., MassLynx, Analyst, Xcalibur).
- Knowledge of chromatographic principles, ionization techniques (ESI, APCI), and mass analyzers.
- Familiarity with regulatory guidelines (ICH, FDA, EMA) for analytical methods.
Soft Skills:
- Strong analytical and problem-solving abilities.
- Excellent documentation and communication skills.
- Ability to work independently and as part of a multidisciplinary team.
Data Integrity and Documentation
- Ensure accuracy, reliability, and confidentiality of all laboratory records and data.
- Enforce adherence to ALCOA+ principles for data integrity.
Troubleshooting and CAPA Management
- Investigate quality-related issues, perform root cause analysis, and lead implementation of effective corrective and preventive actions (CAPAs).
Cross-functional Collaboration
- Collaborate with AR&D, QA, and other departments to align quality strategies.
- Communicate quality metrics, performance, and issues to leadership and stakeholders.
Quality System Contributions
- Support development and implementation of quality management systems (QMS).
- Review and approve analytical methods, validation protocols, and reports.
Audit and Complaint Management
- Lead or support internal and external audits.
- Manage customer complaints and conduct trending analysis to drive quality improvements.
Technical Skills:
- Hands-on experience and data interpretation of analytical instruments like LCMS,
- Thorough understanding of cGMP, GLP, and regulatory requirements.
- Good documentation and analytical skills
Behavioral & Leadership Skills:
- Strong analytical and problem-solving skills.
- Excellent communication and interpersonal abilities.
- Demonstrated ability to lead cross-functional teams and drive a culture of quality.
Why JanSat?
- Operating at pace and agile decision-making using evidence and applying judgement to balance pace, rigour and risk.
- Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
- Continuously looking for opportunities to learn, build skills and share learning.
- Sustaining energy and well-being.
- Building strong relationships and collaboration, honest and open conversations.
- Budgeting and cost-consciousness.
