Sr. Scientist, Analytical R&D
Merck
4 hours ago
Remote friendly (West Point, PA)
United States
Operations
Senior Scientist (Analytical Method Validation Design)
Responsibilities
- Lead creation of validation designs and author validation and transfer protocols and reports for analytical test methods in the biologics and vaccines portfolio.
- Use project management skills to support validation and transfer activities for pipeline commercialization and inline supply projects.
- Partner with internal and external labs to execute method validations and transfers and ensure proper implementation at testing sites.
- Maintain timelines by managing review and approval cycles for validation documentation and communicating clearly with key stakeholders.
- Communicate across functions to support management/governance teams with risk escalation, issue management, and mitigation plan development.
Requirements
- Bachelor’s degree in a chemistry or biology related field with at least 5 years of relevant experience, or
- Master’s degree with at least 3 years of relevant experience in analytical development or quality control.
- Hands-on knowledge of technical aspects of drug substance and drug product analytical methods for release, stability, process monitoring, and characterization of biologics and vaccines.
Preferred
- Strong understanding of regulatory validation guidelines and experience implementing validation best practices.
- Proven track record managing processes; ability to track, support, and communicate milestone delivery.
- Ability to work independently and in cross-functional teams (in-person or remotely).
- Strong cGMP knowledge and experience applying it to analytical activities within a quality management system.
Skills (Required/Relevant)
- Analytical method development, assay development, method validation
- Technical writing, project/process management, issue management and mitigation
- Chromatographic techniques; UPLC
- NMR analysis; PAT
- Quality management; good manufacturing practices (GMP)
Application Instructions
- Apply via https://jobs.merck.com/us/en (deadline listed on the posting).
Responsibilities
- Lead creation of validation designs and author validation and transfer protocols and reports for analytical test methods in the biologics and vaccines portfolio.
- Use project management skills to support validation and transfer activities for pipeline commercialization and inline supply projects.
- Partner with internal and external labs to execute method validations and transfers and ensure proper implementation at testing sites.
- Maintain timelines by managing review and approval cycles for validation documentation and communicating clearly with key stakeholders.
- Communicate across functions to support management/governance teams with risk escalation, issue management, and mitigation plan development.
Requirements
- Bachelor’s degree in a chemistry or biology related field with at least 5 years of relevant experience, or
- Master’s degree with at least 3 years of relevant experience in analytical development or quality control.
- Hands-on knowledge of technical aspects of drug substance and drug product analytical methods for release, stability, process monitoring, and characterization of biologics and vaccines.
Preferred
- Strong understanding of regulatory validation guidelines and experience implementing validation best practices.
- Proven track record managing processes; ability to track, support, and communicate milestone delivery.
- Ability to work independently and in cross-functional teams (in-person or remotely).
- Strong cGMP knowledge and experience applying it to analytical activities within a quality management system.
Skills (Required/Relevant)
- Analytical method development, assay development, method validation
- Technical writing, project/process management, issue management and mitigation
- Chromatographic techniques; UPLC
- NMR analysis; PAT
- Quality management; good manufacturing practices (GMP)
Application Instructions
- Apply via https://jobs.merck.com/us/en (deadline listed on the posting).