Analytical Analyst

Job Description

As an Analytical Analyst, you'll play an important role in the day-to-day operation 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 minimum supervision. The candidate will be responsible for troubleshooting any OOS/OOT results that are generated in the Analytical Laboratory. The candidate will be responsible for generating and reviewing analytical method validation/transfer protocols and managing laboratory supplies for method transfer/validation. The candidate will help prepare and maintain an inspection-ready status within the laboratory to support regulatory audits. Experience with analysis of biologics including bioassays is highly desirable.

Responsibilities:

• To perform routine analytical activities as required to support day-to-day laboratory operations.
• To perform analytical testing.
• To prepare and execute method transfer protocols and generate reports.
• To perform method validation/compendial method verification.
• To be actively involved in internal investigations e.g. Laboratory Out of Specifications, Incidents & Deviations etc.
• To ensure that all work is carried out in compliance with the required company standards and conforms to cGxP, relevant SOPs, and safety and environmental guidelines.
• To identify continuous improvement opportunities.
• To Implement Health & Safety requirements as per site documentation including SOPs, Safety Statement
• Report any defects or potential hazards.

Qualifications and Skills Required:

• Minimum of bachelor's degree in pharmaceutical sciences/chemistry or chemical/bioengineering.
• 5 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 company.
• Team player
• Ability to communicate clearly and concisely verbally and in writing
• Working in the Laboratory as and when required.
• Proficient in Microsoft Office.
• Professional, proactive demeanor.
• Strong interpersonal skills.
• Excellent written and verbal communication skills.

Morgan McKinley is in partnership with Horizon Therapeutics.