Sr. Scientist, Analytical R&D
About The Position
An excellent opportunity is available for a Senior Scientist specializing in analytical method validation design. The primary function of this role is to author and manage validation and transfer protocols and reports for analytical test methods in the biologics and vaccines portfolio within our company. As a Senior Scientist, you will collaborate closely with other functional groups to ensure that methods are validated to current regulatory standards and implemented at their designated testing sites. This vital process will support the successful commercialization of large molecule products and ensure a standardized validation approach across all programs. Bring energy, knowledge, and innovation to carry out the following: 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 will 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 will all key stakeholders. Communicate effectively across functions and departments to support management and governance teams in escalating risks, managing issues, and developing mitigation plans. In order to excel in this role, your experience will more than likely include: 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. Preferred: 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. As a company, we are committed to all that we do. We keep the patient at the very heart of all that we do and strive to find solutions and treatments for some of the world's most challenging healthcare needs. As an equal opportunity employer, we are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. Please don't hesitate to contact the Talent Acquisition Advisor assigned to this role should you need any support during our recruitment process. We are committed to flexible working where possible, and this is why our Company has introduced a new hybrid working model for office-based colleagues around the world. Please feel free to speak to us about what flexibility means to you during your application or click on the link to find out more about our hybrid working model So, if you are ready to: Invent solutions to meet unmet healthcare needs, please apply today. #AR&D
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.
Nice To Haves
- 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 will 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 will all key stakeholders.
- Communicate effectively across functions and departments to support management and governance teams in escalating risks, managing issues, and developing mitigation plans.
Benefits
- We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days.
- More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Number of Employees
5,001-10,000 employees
