Scientist III

About the role

The Analytical Development Scientist III at Kindeva plays a critical role in ensuring the quality and efficacy of pharmaceutical products, particularly focusing on biologics and small-molecules. This position involves designing, executing, and validating analytical methods, leading technical investigations, and collaborating across various departments.

Responsibilities

• Design, execute, and document analytical method development, optimization, transfer, verification, and validation with a primary emphasis on biologics (proteins, peptides, mAbs).
• Serve as the analytical SME during method transfers, ensuring successful execution of protocols, data evaluation, and issue resolution.
• Author and review method transfer/validation protocols and technical reports per FDA, ICH, USP/EP guidelines.
• Handle risk assessment, method establishment, analytical testing for Extractable & Leachable, Elemental Impurities, Residual Solvents and Nitrosamines as applicable.
• Support specification set up, regulatory filing, internal and external inspections.
• Perform non-routine and routine analytical testing for raw materials, in-process samples, finished products, and stability samples as needed.
• Support cleaning validation, production investigations, and evaluation of APIs, excipients, and components.
• Lead troubleshooting of complex analytical and biochemical assays and support root-cause analysis for deviations and OOS investigations.
• Laboratory Testing & Support
• Participate in the qualification and implementation of new analytical instrumentation, including biophysical and chromatographic platforms.
• Identify, propose, and implement process and method improvements to enhance efficiency, robustness, and compliance.
• Maintain expertise with advanced analytical technologies and ensure appropriate application within QC workflows.
• Conduct periodic reviews of SOPs and identify opportunities for process optimization and drive improvements in testing workflows and lab systems.
• Provide technical mentorship and training to QC chemists and junior scientists on analytical techniques, method execution, and data interpretation.
• Prepare, review, and update SOPs, analytical methods, procedures, and technical documents projects.
• Collaborate closely with Manufacturing, QA, Validation, and Process Transfer on cross-functional and technical challenges.
• Ensure good documentation practices (GDP), data integrity, and adherence to cGMP expectations.
• Other duties, including weekend/off-shift work as assigned in support of laboratory and manufacturing operations.

Qualifications

• Bachelor’s degree in Chemistry, Biochemistry, or a related scientific field with 9+ years of relevant industry experience.
• Master’s degree in Chemistry, Biochemistry or related field with 7+ years of relevant experience; or PhD in Chemistry, Biochemistry or related field with 5+ years of relevant experience.
• Equivalent combinations of education, training, and experience may be considered.
• Strongly preferred: experience in a GMP-regulated QC or Analytical Development environment, particularly supporting biologics (proteins, peptides, mAbs) and small-molecules.
• Extensive hands-on experience with biochemical and analytical techniques, including HPLC/UPLC, LC-MS, GC/MS, FTIR, SDS-PAGE, ELISA, Western Blot, protein concentration assays using plate reader, Karl Fischer, titration, pH, and general wet chemistry.
• Proficiency with chromatography data systems such as Empower, Chromeleon, and familiarity with modern analytical software platforms.
• Strong understanding of cGMP, FDA/ICH guidance, method validation principles, data integrity requirements, and laboratory safety standards.
• Demonstrated ability to troubleshoot complex analytical issues and provide sound scientific recommendations.
• Ability to author clear, comprehensive technical reports, method documents, protocols, and SOPs.
• Ability to perform statistical calculations and generate data graphs.

Benefits

At Kindeva, we offer competitive compensation packages, comprehensive benefits, and a supportive work environment. We are committed to fostering a diverse and inclusive workplace where all employees feel valued and empowered to contribute their best work.