Job Description
As an Analytical Analyst, you will play a vital role in the day-to-day operations of the Analytical laboratory and supporting site activities.
Position Summary:
The Analytical Analyst reports to the Quality Control Manager and is responsible for analytical method transfers, and method validations/verifications with minimal supervision. The candidate will be responsible for troubleshooting any OOS/OOT results generated in the Analytical Laboratory. They will generate and review analytical method validation/transfer protocols and manage laboratory supplies for method transfer/validation. This role will also contribute to preparing and maintaining an inspection-ready status within the laboratory to support regulatory audits. Experience with analysis of biologics, including bioassays, is highly desirable.
Responsibilities:
* Perform routine analytical activities to support day-to-day laboratory operations.
* Perform analytical testing.
* Prepare and execute method transfer protocols and generate reports.
* Perform method validation/compendial method verification.
* Participate actively in internal investigations (e.g., Laboratory Out of Specifications, Incidents & Deviations).
* E nsure all work is carried out in compliance with company standards and conforms to cGxP, relevant SOPs, and safety and environmental guidelines.
* Identify continuous improvement opportunities.
* Implement Health & Safety requirements as per site documentation, including SOPs, Safety Statement.
* Report any defects or potential hazards.
Qualifications and Skills Required:
* Bachelor's degree in pharmaceutical sciences, chemistry, or chemical/bioengineering.
* Five years' experience in the pharmaceutical industry.
* Experience in analytical method development, method validations, development, optimization, validation, continuous improvement, troubleshooting, tech transfer, operations, risk analyses/FMEA for drug substance (small molecules), drug product.
* Data analysis and presentation skills.
* Problem-solving skills.
* Sterile/Biologics experience required.
* Understanding of US, EU, and ICH Good Manufacturing Practices regulation concepts.
* Demonstrated leadership in a fast-paced environment.
* Team player.
* Ability to communicate clearly and concisely verbally and in writing.
* Working in the Laboratory as needed.
* Proficient in Microsoft Office.
* Professional, proactive demeanor.
* Strong interpersonal skills.
* Excellent written and verbal communication skills.