Sr. Scientist – Validation Design
| Company | Merck |
|---|---|
| Location | North Wales, PA, USA, Linden, NJ, USA, Dublin, Ireland |
| Salary | $114700 – $180500 |
| Type | Full-Time |
| Degrees | Bachelor’s, Master’s |
| Experience Level | Senior |
Requirements
- Bachelor’s degree in a chemistry or biology related field with a minimum of 5 years of relevant experience or Master’s degree with a minimum of 3 years of relevant experience in analytical development or quality control
- Knowledge in the technical aspects of drug substance and drug product analytical methods used for release, stability, process monitoring and characterization of biologics and vaccines, supported by prior hands-on experience
- Strong understanding of regulatory validation guidelines and prior experience of successfully implementing validation best practices
- Proven track record of managing processes with the ability to effectively track, support and communicate timely delivery of milestones
- Demonstrated ability to work both independently and within cross-functional teams, whether in-person or remotely, fostering collaboration and achieving team objectives
- Strong knowledge and experience in application of current Good Manufacturing Practices (cGMP) to analytical activities within a quality management system
Responsibilities
- Take the lead in creating validation designs and authoring validation and transfer protocols and reports for analytical test methods in the biologics and vaccines portfolio
- Apply project management skills to support validation and transfer activities for pipeline commercialization and inline supply projects
- Work closely with internal and external labs to support the execution of method validations and transfers to ensure proper implementation of methods at the testing sites
- Ensure adherence to timelines by effectively managing review and approval cycles of validation documentation, while maintaining open and clear communication with all key stakeholders
- Communicate effectively across functions and departments to support management and governance teams in escalating risks, managing issues, and developing mitigation plans
Preferred Qualifications
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No preferred qualifications provided.