Sr. Scientist, Analytical R&D
Merck
4 hours ago
Remote friendly (Rahway, NJ)
United States
Operations
Senior Scientist (Analytical Method Validation Design)
Responsibilities:
- Lead the creation of validation designs and author 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 execution of method validations and transfers and ensure proper implementation at testing sites.
- Manage review and approval cycles of validation documentation to meet timelines; maintain open, clear communication with key stakeholders.
- Communicate across functions to support management and governance teams in escalating risks, managing issues, and developing mitigation plans.
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.
- Knowledge of drug substance and drug product analytical methods used for release, stability, process monitoring, and characterization of biologics and vaccines, supported by hands-on experience.
Preferred:
- Strong understanding of regulatory validation guidelines and experience implementing validation best practices.
- Track record managing processes to track, support, and communicate timely milestone delivery.
- Demonstrated ability to work independently and in cross-functional teams (in-person or remotely).
- Strong knowledge and experience applying cGMP to analytical activities within a quality management system.
Required/Role-Related Skills:
- Analytical method development; assay development; method validation; technical writing; project management; quality management; issue management; mitigation; strategic thinking; technical communication; analytical/biological testing and characterization.
- Relevant analytical techniques/experience areas include chromatographic techniques (e.g., UPLC), NMR analysis, bioanalytical analysis, cell-based assays, biochemical/biological assessments.
Application Instructions:
- Apply via https://jobs.merck.com/us/en (or via Workday Jobs Hub if a current employee). Application deadline is stated on the posting.
Responsibilities:
- Lead the creation of validation designs and author 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 execution of method validations and transfers and ensure proper implementation at testing sites.
- Manage review and approval cycles of validation documentation to meet timelines; maintain open, clear communication with key stakeholders.
- Communicate across functions to support management and governance teams in escalating risks, managing issues, and developing mitigation plans.
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.
- Knowledge of drug substance and drug product analytical methods used for release, stability, process monitoring, and characterization of biologics and vaccines, supported by hands-on experience.
Preferred:
- Strong understanding of regulatory validation guidelines and experience implementing validation best practices.
- Track record managing processes to track, support, and communicate timely milestone delivery.
- Demonstrated ability to work independently and in cross-functional teams (in-person or remotely).
- Strong knowledge and experience applying cGMP to analytical activities within a quality management system.
Required/Role-Related Skills:
- Analytical method development; assay development; method validation; technical writing; project management; quality management; issue management; mitigation; strategic thinking; technical communication; analytical/biological testing and characterization.
- Relevant analytical techniques/experience areas include chromatographic techniques (e.g., UPLC), NMR analysis, bioanalytical analysis, cell-based assays, biochemical/biological assessments.
Application Instructions:
- Apply via https://jobs.merck.com/us/en (or via Workday Jobs Hub if a current employee). Application deadline is stated on the posting.