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Kindeva Drug Delivery

Scientist III

Bridgeton, MO · On-site

Author and review method transfer/validation protocols and technical reports per FDA, ICH, USP/EP ... Other duties, including weekend/off-shift work as assigned in support of laboratory and ...

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Scientist III

Scientist III

Kindeva Drug Delivery

Bridgeton, MO • On-site

Full-time

Re-posted 27 days ago

Job description

Our Work Matters
At Kindeva we make products that save lives, ensuring better health and well-being for patients around the world. The Analytical Development Scientist III functions as a senior technical expert within the QC organization, supporting analytical method transfer, verification, and validation activities for both small-molecule and biologic (peptide and protein, including mAbs) products. This role plays a key part in establishing analytical capabilities for a new CDMO site and may perform QC in-process, release, and stability testing as needed.
The Impact You Will Make
The scientist works independently to design, execute, and troubleshoot analytical procedures; leads technical investigations; supports production and cleaning validation activities; and collaborates with cross-functional teams such as Manufacturing, Quality, Validation and Process Transfer. This position requires deep expertise in advanced analytical and biochemical techniques, strong scientific judgment, and the ability to mentor other laboratory personnel. Work must comply with cGMP regulations, compendial standards (USP/NF, EP), site policies, and applicable SOPs.
ROLE 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 operation

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;
  • 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-molecule
  • Experience performing method transfer, method validation, compendial verification, and analytical support activities for CDMO or regulated biopharma environments
  • 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
  • Be able to meet scheduled timelines in a dynamic CDMO environment

California residents should review our Notice for California Employees and Applicants before applying.
Kindeva does not accept unsolicited assistance from headhunters or recruitment firms for any of our job openings. Any resumes or candidate profiles submitted to Kindeva employees-regardless of format-without a valid, signed agreement and an approved job order from an authorized signatory in Talent Acquisition will be considered the sole property of Kindeva. No fees will be paid in the event that a candidate is hired as a result of an unsolicited resume or referral.
Equal Opportunity Employer:
Kindeva Drug Delivery is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, Protected Veteran status, sexual orientation, or any other characteristic protected by federal, state or local law.
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