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

Job Description

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 & qualification of release and stability methods, to join our Center of Excellence Microbiology team. The primary responsibility is to manage and oversee validation and transfer of microbiological test methods for all modalities from our Research & Development Division to our Manufacturing Division global network. You will work closely with other analytical groups in ARD , Global Quality and Regulatory Affairs-CMC to ensure that validated methods are appropriately transferred from our Research & Development Division space our Manufacturing Division testing sites.   

Job Responsibilities:

• Develop microbiological method validation protocols/reports, 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.

Required Qualifications:

• Education & experience: Bachelor's degree in, (Micro-)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 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, 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

Preferred Qualifications:

• 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.

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