Job Description
As a Senior Scientist, you'll play an important role in leading development, deployment, and improvement of validation processes within the QC department to ensure the maximum levels of performance.
As a Senior Scientist, you'll play an important role in leading development, deployment, and improvement of validation processes within the QC department to ensure the maximum levels of performance and compliance are maintained.
Position Summary:
The purpose of this position is to be the subject matter expert in our Quality Control department and be a recognized expert in this industry. The candidate will ensure equipment is maintained in a validated state meeting cGMP requirements.
Responsibilities:
Laboratory
1. Lead the team in the Introduction, validation and execution of methods.
2. Review execution of analytical method validations and transfers and write technical protocols and reports.
3. Review and trend data.
4. Lead investigations and address deviations.
5. Supervise and execute assigned tasks and projects.
6. Training of QC staff
7. Analyze and optimize current lab/business processes in the laboratories and support implementation activities of the technologies and methodologies.
8. Assist in scheduling and prioritization of laboratory testing.
9. Act as delegate of the AD of QC Analytical or Microbiology if required.
10. Coaching/Mentoring - support members of the team with problem solving and skill development to aid learning and early problem resolution.
11. To identify and make recommendations for improvements as part of a team within or outside the department in order to ensure continuous improvement.
12. To assist in the preparation for internal / customer/ regulatory inspections.
13. Recruitment - assist with recruitment of team members in line with resource requirements to job spec.
Health, Safety and the Environment
14. Comply with all EHS policies and procedures.
Quality Compliance
15. Comply with all quality policies and procedures.
Production
16. Provide technical knowledge and support.
17. Participate in risk assessments as a Subject Matter Expert (SME).
Qualifications and Skills Required:
18. BSC or MSc in biological sciences
19. Minimum of 5 years industrial / laboratory experience in GMP Analytical Laboratory.
20. Demonstrated ability to introduce, validate and optimise methods.
21. Experience working in a cross functional team environment.
22. Analyze and optimize current lab/business processes in the laboratories and support implementation activities of the technologies and methodologies.
23. Experience with analytical testing with Ultrahigh Pressure Liquid Chromatography (UPLC)/High Performance Liquid Chromatography (HPLC), Capillary Electrophoresis, Mass Spectrometry or other large molecule characterization technique
24. Knowledge of Analytical Methodologies and sound scientific understanding of Critical Quality Attributes as well as data analysis and statistics for setting specifications
25. Team player with ability to peer to peer coaching
26. Proficient in Microsoft Office.
27. Professional, proactive demeanor.
28. Strong interpersonal skills.
29. Excellent written and verbal communication skills.
Morgan McKinley is in partnership with Horizon Therapeutics.
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