Analytical Chemist — CMC & Regulatory Support

CRITITECH PARTICLE ENGINEERING SOLUTIONS; Lawrence (KS); On-site; USD 75,000 - 105,000; Full time

Job summary

CritiTech Particle Engineering Solutions in Lawrence, KS, is seeking a scientific professional to support CMC activities and collaborate with scientists and management on development of NCEs, APIs, and related regulatory filings.

The role involves lab development, analytical support for proof of concept studies, manufacturing support for clinical trials, data generation for CMC documents, and coordination with QA/regulatory affairs.

Qualifications

• BS in chemistry, biology, engineering or related pharmaceutical field with 3+ years industry background in pharmaceutical product development – or –
• MS in chemistry, biology, engineering or related pharmaceutical field with 2+ years industry background in pharmaceutical product development.
• 2+ years preparing and supporting CMC documentation for INDs and NDA’s.
• Experience in working with people in a multi-disciplinary team environment.

Responsibilities

• Participates in lab development in support of CMC section of NDA/SNDA with QA/Regulatory Affairs direction.
• Provides analytical support for proof of concept studies, feasibility studies, routine manufacturing, and troubleshooting using CritiTech’s equipment.
• Performs production activities in support of clinical trials, including filling, environmental monitoring, visual inspection, and packaging of vials.
• Generates data to support CMC documents and regulatory filings.
• Assists in QA on complaint samples and manufacturing/packaging issues.
• Performs release and stability testing and supports technology transfer and stability protocols.

Skills

Leadership

Analytical skills

Teamwork

Communication

Interpersonal flexibility

Knowledge sharing

Resource management

Education

BS in chemistry, biology, engineering or related pharmaceutical field

MS in chemistry, biology, engineering or related pharmaceutical field

Advanced degree in chemistry or pharmacy

Tools

HPLC

GC

IR

Job description

CritiTech Particle Engineering Solutions in Lawrence, KS, is seeking a scientific professional to support CMC activities and collaborate with scientists and management on development of NCEs, APIs, and related regulatory filings.

The role involves lab development, analytical support for proof of concept studies, manufacturing support for clinical trials, data generation for CMC documents, and coordination with QA/regulatory affairs.