The Principal Research Scientist I is responsible for ensuring uninterrupted operations of testing facilities; overseeing inventory management and compliance with CDC requirements; ensuring departmental compliance with cGMP regulations; coordination of stability studies; overseeing all aspects of coordination of activities with PBL and analysis of mLD 50 data. Support a team of analysts who will be involved in day-to-day operations of the department.
The Principal Research Scientist I will lead groups of analysts engaged in laboratory support operations to ensure uninterrupted operation of all critical instruments, storage devices, stability chambers. This position will oversee inventory of select toxin samples including coordination of shipping and receiving of highly toxic compounds ensuring compliance with CDC regulations. This role will oversee coordination of development and GMP stability studies as well as compilation and traceability of all relevant analytical results. The Principal Research Scientist II will ensure departmental compliance with cGMP requirements, will lead method validation activities and any relevant investigations/audits associated with QC activities of the department. This position will coordinate mLD 50 testing at PBL and will analyze and compile all relevant analytical results associated with this method.
The The Principal Research Scientist I will contribute with a broader leadership team, assisting with Biopharmaceutical Development program review and assessment, as well as helping to set and achieve site objectives. This individual will write, review, and approve documents of various types, including scientific reports and documentation for regulatory submissions, method qualification/validation protocols and reports, and policies. His team will also be supporting analytical outsourcing activities, as needed. The Principal Research Scientist II will ensure phase-appropriate assay validation compliant with internal policies and cGMP requirements. This leader would support proper development and training of staff members and ensure regulatory and EHS compliance.
This position requires the individual to work with and in areas requiring select agents and toxins access (i.e. Biosafety level 2 laboratories). Access to and use of select agents and toxins is regulated by federal policies. Therefore, the candidate must conduct all work activities in compliance with AbbVie internal and applicable regulatory requirements. AbbVie internal requirements include compliance with ethics, environmental health and safety, financial, human resources, and general business policies, requirements and objectives.
Key Responsibilities:
Strategic Leadership: Set clear goals and milestones for the assay development team.
Team Management: Manage a diverse and high-performing team of and foster a collaborative and innovative work culture.
Regulatory Compliance: Ensure that all assay validation activities adhere to relevant regulatory standards and guidelines, including but not limited to FDA, EMA, ICH.
Cross-functional Collaboration: Collaborate closely with other departments, including Biologics Discovery CMC, Drug Product Development, Drug Substance, Drug Delivery, Operations, Quality, Business and Clinical Development to ensure seamless product development.
Resource Allocation: Manage budgets, resources, and external partnerships to maximize the efficiency and effectiveness of the departmental operations.
Adherence to current health authority guidelines and regulations: Implement procedures to ensure analytical team members are aware of current guidelines and procedures. Assay velidation should be phase appropriate and ensure quality and reliability of products.
