Analytical Development Scientist II

Kindeva Drug Delivery; Missouri; On-site; USD 85,000 - 125,000; Full time

Job summary

Kindeva Drug Delivery is hiring an Analytical Development Scientist II to support method transfer, verification, and validation for biologics and small molecules in a CDMO setting. You will collaborate across Manufacturing, Quality, Validation, and Technical Operations to ensure compliant analytical activities and robust data integrity.

The role requires a strong background in analytical chemistry, hands-on experience with HPLC/LC-MS, and disciplined documentation.

Qualifications

• Over 5 years of industry experience in GMP-regulated pharma/CDMO.
• Experience with biologics and small molecule products.
• Hands-on analytical method transfer, validation, verification, and testing.
• Proficiency with chromatography data systems and lab software.
• Strong data analysis, statistics, and technical documentation.

Responsibilities

• Execute analytical method transfer, verification, validation, and troubleshooting for biologic and small molecule products.
• Perform routine and non-routine analytical testing of materials, in-process samples, and finished products.
• Support investigations, regulatory submissions, cleaning validation, and manufacturing support.
• Maintain and qualify analytical instrumentation and laboratory systems.
• Identify improvements to methods, processes, efficiency, and data integrity.
• Collaborate with QC, Manufacturing, QA, Validation, and Technical Operations; provide training.
• Author methods, SOPs, protocols, and reports with cGMP and GDP compliance.
• Support off-shift, weekend, or manufacturing-related activities as needed.

Skills

Analytical method development

Data analysis

Cross-functional collaboration

Education

Bachelor's degree in Chemistry

Master's degree in Chemistry/Biochemistry

PhD in related field

Tools

Empower

Chromeleon

HPLC

UPLC

LC-MS

Job description

Our Work Matters

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

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.

California residents should review our Notice for California Employees and Applicants before applying.

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.