Job Description
As an Analytical Analyst, you'll play a key role in the day-to-day operation of the laboratory and supporting activities.
Position Summary:
The Analytical Analyst reports to the Quality Control Manager and is responsible for analytical method transfers, validations/verifications, with minimal supervision. The candidate will be responsible for troubleshooting out-of-specification results generated in the laboratory. They will generate and review analytical method validation/transfer protocols and manage laboratory supplies for transfer/validation. The candidate will assist in preparing and maintaining an inspection-ready status within the laboratory to support regulatory audits. Experience with biologic analysis, including bioassays, is highly desirable.
Responsibilities:
* Perform routine analytical activities to support laboratory operations.
* Conduct analytical testing.
* Prepare and execute method transfer protocols and generate reports.
* Perform method validation/compendial method verification.
* Participate in internal investigations (e.g., Laboratory Out of Specifications, Incidents & Deviations).
* Ensure all work conforms to company standards, cGxP, relevant SOPs, safety, and environmental guidelines.
* Identify opportunities for continuous improvement.
* Implement Health & Safety requirements according to site documentation and SOPs.
* Report defects or potential hazards.
Qualifications and Skills Required:
* Bachelor's degree in pharmaceutical sciences, chemistry, or chemical/bioengineering.
* 5 years' experience in the pharmaceutical industry.
* Experience in analytical method development, method validations, optimization, and troubleshooting.
* Data analysis and presentation skills.
* Problem-solving skills.
* Sterile/Biologics experience required.
* Understanding of US, EU, and ICH Good Manufacturing Practices regulations.
* Demonstrated leadership in a fast-paced environment.
* Team player.
* Excellent communication and interpersonal skills.
* Proficient in Microsoft Office.
Horizon Therapeutics is a partner organization.