Job Title: Chemist – Analytical Chemistry (Medical Device)Job DescriptionThis Chemist role focuses on performing qualitative and quantitative analyses to support new product development within a medical device environment. You will develop and validate analytical methods, maintain and operate advanced instrumentation, and ensure compliance with cGMP and regulatory standards. The position involves close collaboration with cross-functional teams, preparation of technical documentation, and active participation in the strategic and day-to-day operations of the analytical laboratory.
Responsibilities- Perform routine and non-routine qualitative and quantitative analyses of raw materials, in-process samples, and finished products using techniques such as FTIR, ICP-MS, LC-UV/LC-MS, GC-FID/MS, and related methods.
- Develop and improve analytical methods and validate these methods in alignment with applicable regulatory standards.
- Support new product development activities by executing analytical testing, conducting compatibility studies, and carrying out development plans.
- Apply a strong understanding of underlying chemistry to method development, data interpretation, and troubleshooting analytical challenges.
- Prepare and review technical documents, including analytical protocols, reports, and data sheets for defined analytical parameters.
- Conduct all analytical work in compliance with cGMP, regulatory standards, and safe laboratory practices, and document any variances appropriately.
- Frequently apply regulatory standards to testing of drug and device products to ensure compliance and data integrity.
- Maintain a collaborative working environment with cross-functional teams within the Drug Delivery Systems group.
- Contribute to multiple projects simultaneously, including preparation of scientific presentations and research articles.
- Play an integral role in both strategic and tactical operations of the analytical department by providing technical input and analytical expertise.
- Independently investigate and resolve analytical issues, identify root causes, and propose preventive and corrective solutions.
- Prepare reagents and solutions, perform general laboratory duties such as equipment maintenance, cleaning, sample and standards preparation, and housekeeping.
- Outline and implement effective solutions for laboratory investigations and support continuous improvement initiatives in laboratory operations.
Essential Skills- Bachelor’s degree in Chemistry or a closely related discipline with a strong chemistry focus.
- 3–4 years of hands-on experience with analytical chemistry techniques, including mass spectrometry.
- Demonstrated experience in developing analytical methods and performing material or product characterization using a range of chemical analysis techniques in academic or industry settings.
- Proficiency in advanced analytical instrumentation, including FTIR, LC-UV/LC-MS, GC-FID/MS, and ICP-MS.
- Strong background in analytical chemistry with substantial hands-on laboratory experience.
- Ability to interpret complex analytical data and apply mathematical concepts relevant to quantitative and qualitative laboratory analyses.
- Experience working in environments that follow cGMP and regulatory standards.
- Competence in data analysis and documentation of analytical results.
- Experience with gas chromatography (GC, GC-MS, GC-FID) and liquid chromatography (LC, HPLC, LC-MS).
- Familiarity with mass spectrometry techniques and related data interpretation.
- Knowledge of safe laboratory practices and proper handling of chemicals and instrumentation.
Additional Skills & Qualifications- Experience with a broad range of analytical chemistry techniques, including FTIR, ICP-MS, LC-UV/LC-MS, GC-FID/MS, HPLC, gas chromatography, and mass spectrometry.
- background in applying analytical methods specifically within drug delivery systems or medical device settings.
- Experience preparing scientific presentations and contributing to research articles.
- Ability to work on multiple projects simultaneously while maintaining high quality and accuracy.
- Strong problem-solving skills with the ability to investigate analytical issues and implement effective preventive solutions.
- Comfort working within cross-functional teams and contributing to both strategic and tactical departmental initiatives.
- Familiarity with continuous improvement practices in laboratory operations.
Work EnvironmentThe role is based in an analytical chemistry laboratory within a medical device organization. You will work with advanced analytical i