Scientist - Analytical Development

Summary:

The successful candidate will play a crucial role in ensuring the quality and reliability of our products through rigorous analytical assessments and will work closely with cross-functional teams to meet project objectives.

Key Responsibilities:

• Develop, qualify and transfer GC, HPLC, UPLC and mass spectrometry based assays of starting materials, raw materials, intermediates and excipients to suppliers, CMOs and QC.
• Identify impurity profiles and provide data to set impurity limits.
• Understand and apply advanced scientific principles, theories, concepts, practices and standards to process and analytical development.
• Author and review method development and qualification reports and SOP’s for test methods, as well as transfer / qualification protocols and reports related to critical starting materials / intermediates / excipients.
• Provide analytical support externally and internally.
• Develop and validate analytical methods for the characterization of drug substances and drug products.
• Collaborate with other scientists and teams to design experiments and interpret results, providing technical guidance and insights.
• Maintain an organized laboratory environment, ensuring adherence to safety and quality standards.

Skills and Competencies:

• Strong analytical thinking and problem-solving skills with attention to detail.
• Proficient in laboratory techniques such as HPLC, GC, and MS.
• Effective communication skills, with a proven ability to communicate complex scientific concepts clearly.
• Demonstrated ability to work both independently and collaboratively in a team setting.
• Organizational skills to manage multiple projects and timelines efficiently.

Requirements

• Ph.D. in Analytical Chemistry or related disciplines with 1 year biopharmaceutical experience.
• Master degree with 5 years biopharmaceutical experience respectively, with demonstrated chromatographic separation, method development / qualification and structure elucidation expertise.

Preferred qualifications:

• Strong knowledge of fundamental chromatographic separation mechanisms in both gas phase and liquid phase, proven years of excellent hands-on method development and optimization experience on HPLC, UPLC and GC for separation of molecules and isomers.
• Sound background in organic chemistry with a focus on structure characterization and elucidation of synthetic molecules through determination and interpretation of mass spectrometry and NMR data.
• Self-motivated, excellent communication, writing and reviewing skills.
• Familiarity with Waters and Agilent (U)HPLC and Mass Spectrometery hardware. Familiarity with Empower, Masslynx, Masshunter, and XCalibur CDS are preferred.