Senior Scientist, Microbiology - Analytical Research & Development (Onsite)

$111,400 - $175,300/Yr

Merck & Co. - Rahway, NJ

Full-time - Mid Level

Onsite - Rahway, NJ

Chemical Manufacturing

About the position

The CoE Microbiology within Analytical Research and Development (ARD) at our company's Research Laboratories is seeking a senior scientist to work onsite with extensive experience in validation and qualification of release and stability methods. The primary responsibility of this role is to manage and oversee the validation and transfer of microbiological test methods for all modalities from our Research & Development Division to our Manufacturing Division global network. This position requires close collaboration with other analytical groups in ARD, as well as Global Quality and Regulatory Affairs-CMC, to ensure that validated methods are appropriately transferred from our Research & Development Division to our Manufacturing Division testing sites. In this role, you will be responsible for developing microbiological method validation protocols and reports, as well as method transfer protocols and reports. You will also support follow-up studies post-transfer activities as needed. Applying project management tools to support validation and transfer activities for pipeline commercialization and inline supply projects will be a key aspect of your responsibilities. You will manage and serve as the contact for internal and external labs involved in analytical method validation and transfer activities, maintaining timelines and managing the review and approval of validation and transfer protocols and reports. Additionally, you will assist labs with sample and consumable logistics in support of validation and transfer. Effective communication across functions and departments is essential, as you will assist management and governance teams in risk escalation, issue management, and mitigation plan development. You will also support subject matter experts and regulatory colleagues in authoring relevant regulatory submission analytical sections where needed.

Responsibilities

• Develop microbiological method validation protocols/reports and method transfer protocols/reports.
• Support follow-up studies post-transfer activities (RY or WP as needed).
• Apply project management tools to support validation and transfer activities for pipeline commercialization and inline supply projects.
• Manage and serve as contact for internal/external labs in analytical method validation and transfer activities.
• Maintain timelines; manage review and approval of validation and transfer protocols and reports; assist labs with sample/consumable logistics in support of validation and transfer.
• Communicate effectively across functions and departments to assist management and governance teams in risk escalation, issue management and mitigation plan development.
• Support subject matter experts and regulatory colleagues in authoring of relevant regulatory submission analytical sections where needed.

Requirements

• Bachelor's degree in (Micro-)Biology or a related field with a minimum of 5 years of relevant experience, or a Master's degree with a minimum of 3 years of relevant experience in microbiological/analytical development or quality control.
• Knowledge in the technical aspects and prior hands-on experience of microbiological methods used for release, stability, and process monitoring of protein and conjugate vaccines, adjuvants, and biologics such as monoclonal antibodies and small molecules.
• Project management experience tracking, supporting and communicating timely delivery of milestones.
• Ability to work independently and within cross-functional teams; strong team player.
• Strong knowledge and experience in application of current Good Manufacturing Practices to analytical activities within a quality management system.

Nice-to-haves

• Experience using project management, validation and EDMS solutions (e.g. scheduling tools, PowerBI, Kneat, QualityDocs, VeevaVault).
• Knowledge in current major market regulatory frameworks and prior experience in preparing regulatory submissions in common technical document format.
• cGMP experience.
• Rapid Microbiological methods knowledge.

Benefits

• Bonus eligibility
• Long term incentive if applicable
• Health care and other insurance benefits (for employee and family)
• Retirement benefits
• Paid holidays
• Vacation
• Sick days