Proclinical is seeking a QC Microbiologist o join a dedicated team. The successful candidate will be responsible for quality control testing, analytical method transfers, new product introductions, and technical investigations to support GMP operations. This position focuses on bioassay techniques and requires a proactive approach to ensure compliance and continuous improvement.
Responsibilities:
1. Execute bioassay techniques such as ELISA, Receptor Binding, Flow Cytometry, and Cell-based assays.
2. Participate in analytical method transfers and method validations.
3. Develop subject matter expertise on assigned analytical techniques.
4. Review data and results to ensure compliance with specifications and protocols.
5. Analyze data and critically evaluate data quality.
6. Lead bioassay investigations, troubleshooting, and technical projects.
7. Provide technical support for investigations and optimization projects.
8. Implement new technologies and continuous improvement initiatives.
9. Write and execute protocols and reports.
10. Develop, revise, and implement procedures that comply with regulatory requirements.
11. Perform analyses efficiently, consistently, and with high quality.
12. Collaborate with cross-functional stakeholders locally and across the network.
13. Work on non-routine projects and assignments.
Key Skills and Requirements:
14. Proficiency in analytical techniques such as Cell Culture, ELISA, Receptor Binding, Flow Cytometry, and Cell-based assays.
15. Experience in method validation and method transfers is advantageous.
16. Knowledge of GMPs, GLPs, and regulatory requirements for biologics testing.
17. Advanced skills in aseptic techniques.
18. Familiarity with software such as Softmax Pro, LIMS, and Trackwise.
19. Excellent communication skills, both verbal and technical.
20. Strong interpersonal skills and ability to work effectively with diverse teams.
21. Ability to work independently and collaboratively with internal and external partners.
22. Self-motivated, adaptable, and able to deliver in an ambiguous environment.
23. Curious with a strong learning agility.
24. Operationally excellent and organized with a systematic approach to prioritization.
25. Process-oriented to achieve business objectives.