Software Functional Analyst Tester Jobs in O'Fallon, IL

Our Work Matters

At Kindeva, we make products that save lives, ensuring better health and well-being for patients around the world.

The Impact You Will Make

As an Analytical Development Scientist II, you will play a critical role in supporting analytical method transfer, verification, and validation activities for both small molecule and biologic products within a Contract Development and Manufacturing Organization (CDMO) environment. This position contributes to the development and implementation of analytical capabilities while supporting quality control testing, technical investigations, process transfers, and validation activities. You will collaborate closely with the Manufacturing, Quality, Validation, and Technical Operations teams to ensure analytical activities are executed efficiently and in compliance, in support of bringing life-changing therapies to patients around the world.

Responsibilities

Analytical Method Development, Transfer & Validation

• Execute analytical method transfer, verification, validation, and troubleshooting activities supporting both biologic and small molecule pharmaceutical products.

• Perform routine and non-routine analytical testing of raw materials, in-process samples, finished products, stability samples, and validation studies.

• Support technical investigations, specification development, regulatory submissions, and analytical activities associated with cleaning validation and manufacturing support.

Laboratory Operations & Continuous Improvement

• Support the implementation, qualification, and maintenance of analytical instrumentation and laboratory systems.

• Identify and implement opportunities to improve analytical methods, laboratory processes, efficiency, compliance, and overall testing capabilities.

• Maintain technical expertise across a variety of analytical and biochemical techniques while supporting laboratory best practices and data integrity requirements.

Cross-Functional Collaboration & Technical Support

• Collaborate with Quality Control, Manufacturing, Quality Assurance, Validation, and Technical Operations teams to support routine operations and project activities.

• Provide technical guidance and training to laboratory personnel as needed.

• Author and revise analytical methods, protocols, reports, Standard Operating Procedures (SOPs), and other technical documentation while maintaining compliance with current Good Manufacturing Practices (cGMPs) and Good Documentation Practices (GDPs).

• Support occasional off-shift, weekend, or manufacturing-related activities as business needs require.

Qualifications

• Bachelor's degree in Chemistry, Biochemistry, or a related scientific field with 5+ years of relevant industry experience; Master's degree with 3+ years of relevant industry experience; or Ph.D. with 2+ years of relevant industry experience. Equivalent combinations of education, training, and experience may be considered.

• Experience supporting Quality Control or Analytical Development activities within GMP-regulated pharmaceutical, biotechnology, or CDMO environments, including biologics (proteins, peptides, monoclonal antibodies) and small molecule pharmaceutical products.

• Hands-on experience performing analytical method transfer, method validation, compendial verification, troubleshooting, and analytical testing using techniques such as HPLC, UPLC, LC-MS, GC-MS, FTIR, SDS-PAGE, ELISA, Western Blot, protein concentration assays, Karl Fischer titration, pH analysis, and general wet chemistry methods.

• Proficiency with chromatography data systems and laboratory software platforms, including Empower and Chromeleon, along with a strong understanding of cGMP regulations, FDA and ICH guidance, method validation principles, data integrity requirements, and laboratory safety standards.

• Demonstrated ability to troubleshoot analytical issues, critically evaluate data, perform statistical calculations, generate technical reports, protocols, SOPs, and other scientific documentation while providing scientifically sound recommendations and conclusions.

• Strong verbal and written communication skills with the ability to collaborate effectively across cross-functional teams, manage multiple priorities, and meet deadlines in a fast-paced pharmaceutical manufacturing environment.

Physical Requirements

• Specific vision requirements include close vision, distance vision, color vision, and the ability to adjust focus.

• Ability to use computers and laboratory systems for extended periods of time.

• Ability to follow all cGMP, laboratory, and safety procedures.

• Must wear required personal protective equipment (PPE) and perform assigned work safely.

• Ability to use proper lifting techniques and remain aware of workplace hazards.

• Must occasionally lift and/or move up to 25 pounds.

• Ability to support occasional weekend, off-shift, or manufacturing support activities as business needs require.

#LI-Onsite