Senior Analytical Chemist - HPLC/GC Expert (Contract)

Actalent; Shawnee (KS); Sur place; USD 62 000 - 73 000; Plein temps

Avantages offerts par ce poste

Medical, dental & vision

401(k) Retirement Plan

Life Insurance

Paid time off

Résumé du poste

Actalent seeks a skilled Chemist to perform routine and advanced analytical testing of small-molecule substances in a regulated lab. You will lead method transfer and validation activities, support method development for purity, potency, and stability, and help with cleaning validation.

Strong hands-on HPLC/GC and documentation practices are required. The role involves training other lab personnel, drafting SOPs and reports, and ensuring compliance with USP/EP/JP guidelines.

Qualifications

• Experience designing and executing analytical method transfer.
• Experience planning and performing analytical method validations.
• Ability to read USP/EP/JP and apply compendial methodologies.
• Proven record writing SOPs, reports, and investigations.
• Strong documentation and training skills.

Responsabilités

• Perform routine analysis of finished dosage forms and raw materials using validated methods.
• Design and execute method transfer protocols and reports.
• Plan and document analytical method validations with protocols and reports.
• Design and execute cleaning validation protocols and reports.
• Support development of methods for purity, potency, and stability.
• Operate HPLC, GC, and related instruments with proper calibration.
• Prepare reagents and samples following procedures.
• Troubleshoot laboratory equipment and analytical issues.
• Maintain accurate, contemporaneous records per regulatory standards.
• Collaborate to meet testing schedules in a team environment.
• Interpret compendial monographs and analytic methodologies.
• Write SOPs, protocols, and investigation reports.
• Train and mentor other lab personnel.

Connaissances

HPLC method development

GC analysis

Analytical method validation

Method transfer

Documentation practices

Root cause analysis

SOP writing

Training others

Regulatory compliance

Team collaboration

Formation

Bachelors or Masters in Chemistry

Outils

Empower chromatography data system

Description du poste

Actalent seeks a skilled Chemist to perform routine and advanced analytical testing of small-molecule substances in a regulated lab. You will lead method transfer and validation activities, support method development for purity, potency, and stability, and help with cleaning validation.

Strong hands-on HPLC/GC and documentation practices are required. The role involves training other lab personnel, drafting SOPs and reports, and ensuring compliance with USP/EP/JP guidelines.