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:
1. To perform routine analytical activities as required to support day-to-day laboratory operations.
2. To perform analytical testing.
3. To prepare and execute method transfer protocols and generate reports.
4. To perform method validation/compendial method verification.
5. To be actively involved in internal investigations e.g. Laboratory Out of Specifications, Incidents & Deviations etc.
6. 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.
7. To identify continuous improvement opportunities.
8. To Implement Health & Safety requirements as per site documentation including SOPs, Safety Statement
9. Report any defects or potential hazards.
Qualifications and Skills Required:
10. Minimum of bachelor's degree in pharmaceutical sciences/chemistry or chemical/bioengineering.
11. 5 years' experience in the pharmaceutical industry
12. 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
13. Data analysis and presentation skills
14. Problem-solving skills
15. Sterile/Biologics experience required.
16. Understanding of US, EU, and ICH Good Manufacturing Practices regulation concepts
17. Demonstrated leadership in a fast-paced company.
18. Team player
19. Ability to communicate clearly and concisely verbally and in writing
20. Working in the Laboratory as and when required.
21. Proficient in Microsoft Office.
22. Professional, proactive demeanor.
23. Strong interpersonal skills.
24. Excellent written and verbal communication skills.
Morgan McKinley is in partnership with Horizon Therapeutics.
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