Analytical Development Scientist II: Method Transfer

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

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.