Scientist II

Kindeva Drug Delivery; St. Louis (MO); On-site; USD 70,000 - 110,000; Full time

Job summary

Kindeva Drug Delivery in St. Louis, MO is seeking an Analytical Development Scientist II to support method transfer, verification, and validation for biologics and small molecules within a CDMO setting.

You will work across QC, Manufacturing, QA, and Validation, developing assays, troubleshooting, and ensuring data integrity in a cGMP environment. Strong communication and documentation skills are required.

Qualifications

• Bachelor's or higher with 5+ years in GMP pharmaceutical analytics.
• Experience with QC or Analytical Development in GMP/CDMO environments.
• Hands-on method transfer, validation, and troubleshooting experience.
• Proficient with chromatography software; strong regulatory knowledge.

Responsibilities

• Perform analytical method transfer, verification, validation, and troubleshooting.
• Conduct routine analytical testing of materials, in-process samples, finished products, and stability studies.
• Support investigations, regulatory submissions, and cleaning validation activities.
• Collaborate with QC, Manufacturing, QA, Validation, and Technical Operations teams.
• Author and revise methods, SOPs, reports, and technical documentation.
• Provide guidance and training; support off-shift/weekend activities as needed.

Skills

HPLC/UPLC

LC-MS/GC-MS

FTIR

SDS-PAGE

ELISA

Western Blot

Karl Fischer

PH Analysis

Wet Chemistry

cGMP Knowledge

Education

Bachelor's degree in Chemistry/Biochemistry or related field

Master's degree in related field

PhD with 2+ years experience

Tools

Empower

Chromeleon

Job description

Posted Monday, August 3, 2026 at 4:00 AM

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.

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.

Job Family D - Quality - Analytical Quality Development