Senior Analytical Scientist JB-38

We are seeking a Senior Analytical Scientist with expertise in method development, optimization, and validation to join our new Analytical R&D group. This role will focus on developing, optimization and validating analytical methods to support R&D, process development, and regulatory submissions. The ideal candidate will have strong technical expertise in analytical techniques, experience with GMP compliance, and excellent English writing skills for preparing technical reports and support the regulatory submissions.

Key Responsibilities:

• Develop and qualify analytical methods for characterization, stability studies, impurity profiling, and release testing
• Perform method troubleshooting and optimization to improve performance and robustness
• Utilize techniques such as HPLC/UPLC, LC-MS, ELISA, UV-Vis, and electrophoresis (CE, SDS-PAGE)
• Write high-quality analytical reports, validation protocols, and regulatory submissions in English
• Ensure method compliance with regulatory guidelines and Support regulatory filings with well-documented analytical data
• Work closely with R&D and Quality group to support drug development programs
• Assist in the tech transfer of validated methods to QC and provide technical guidance on analytical methods and best practices
• Ensure compliance with data integrity standards (21 CFR Part 11) and maintain accurate laboratory records

Qualifications & Experience:

• Ph.D./ M.S. in Biochemistry or a related field with of industry experience in Analytical R&D within biotechnology, pharmaceuticals, or related fields
• Strong expertise in method development, validation, and troubleshooting.
• Hands-on experience in at least one of the following: chromatography (HPLC/UPLC), mass spectrometry (LC-MS,), spectroscopy (UV-Vis,), electrophoresis (CE, SDS-PAGE), and bioassays (ELISA, qPCR).

Skills:

• Excellent written and verbal English communication skills
• Proven ability to write clear, concise technical reports, regulatory documents, and scientific publications
• Strong problem-solving and analytical thinking abilities
• Ability to work independently and in a team-oriented environment
• Effective collaboration with cross-functional teams