What are the responsibilities and job description for the Scientist - Analytical Development position at BioPharma Consulting JAD Group?
Summary:
BioPharma Consulting JAD Group is seeking a detail-orientedScientist - Analytical Development to join our expanding team. This role involves the development and validation of analytical methods for the characterization of biopharmaceuticals, including small molecules and biologics. 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.
Qualifications
- 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.
