Analytical scientist

TekWissen•Cincinnati, OH

4d•Onsite

About The Position

Analytical scientist/chemist responsible for supporting pharmaceutical development and manufacturing through analytical testing, method development and validation, data review, instrumentation troubleshooting, and laboratory support. The role focuses on delivering accurate, compliant analytical results while meeting project objectives within a GMP/GLP pharmaceutical environment.

Requirements

Bachelor's degree in Chemistry, Biochemistry, or another technical/scientific field, or equivalent experience with 2–3 years of GMP and regulatory experience.
Pharmaceutical industry experience required.
Hands-on experience with chemical testing using chromatographic, spectroscopic, and other analytical techniques.
Strong HPLC/UPLC experience, including assay and related substances.
GC and GC-MS experience with chromatographic troubleshooting.
Dissolution testing experience.
Oral solid dosage (OSD) and ARS experience required.
Analytical method validation experience.
Working knowledge of chemistry, analytical instrumentation, and pharmaceutical quality/regulatory requirements.
Strong written and verbal communication skills.
Strong organizational and problem-solving skills.
Ability to work independently and manage project deliverables.
Commitment to quality, timely delivery, and continuous improvement.
Ability to work safely with hazardous/toxic materials and use required PPE.
Ability to lift up to 40 lbs. without assistance.

Nice To Haves

2–3 years of GMP and regulatory experience preferred.
Empower experience preferred.

Responsibilities

Perform routine chemical and physical testing of pharmaceutical finished products and stability samples.
Use chromatographic, spectroscopic, dissolution, and other analytical techniques.
Develop analytical methods for pharmaceutical raw materials and finished products.
Participate in analytical method validation.
Write and execute validation protocols according to regulatory requirements and laboratory procedures.
Process, review, interpret, document, and report analytical data.
Communicate analytical results to internal teams and external clients.
Maintain and troubleshoot analytical instrumentation.
Support implementation of new analytical methods and processes.
Manage assigned project tasks with minimal supervision.
Ensure project deliverables and next steps are completed on time.
Perform all work in compliance with SOPs, GMPs, GLPs, regulatory requirements, and safety procedures.