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Research Scientist I, Cell and Molecular Biology
2 months ago
Join a dynamic team of innovative professionals and visionary leaders. As a key member of our scientific community, you will engage in meaningful discussions, pose critical questions, and drive impactful results.
Key Responsibilities
The Research Scientist is tasked with facilitating the development, qualification, transfer, and validation of analytical methodologies, with expertise in the following areas:
- Cell-based potency assays and quantitative ELISA (qELISA).
Collaboration with scientific teams is essential to design experimental protocols and execute plans that support biologics process and formulation development, as well as stability assessments.
The individual will independently generate, compile, and analyze data for technical documentation to support regulatory submissions for both new and existing biological products.
Responsibilities also include drafting sections or subsections of technical reports and standard operating procedures (SOPs). The scientist will adeptly perform various analytical techniques to support AbbVie biologics initiatives based on departmental requirements. Maintaining a collaborative and productive laboratory environment that aligns with regulatory and company standards is crucial.
Compliance and Safety
This role necessitates working in environments that require access to select agents and toxins (i.e., Biosafety Level 2 laboratories). Adherence to federal regulations governing the use of select agents is mandatory. Consequently, all work must be conducted in accordance with AbbVie’s internal policies and applicable regulatory guidelines.
AbbVie’s internal policies encompass compliance with ethical standards, environmental health and safety regulations, financial protocols, human resources guidelines, and overarching business objectives.
Method Development
Support the creation of phase-appropriate separation techniques for toxin development initiatives.
Execute the development and validation of analytical methods for the analysis and characterization of biopharmaceuticals. Responsibilities include creating written procedures and protocols, as well as transferring, qualifying, or validating methods as necessary.
Utilize both routine and specialized analytical techniques to characterize and quantify biopharmaceuticals.
Maintain inventory of reagents, document findings in laboratory notebooks, summarize results in written reports, and communicate observations to ensure timely delivery of quality methods to end users.
Adhere to Quality Principles related to data generation and reporting.Collaboration and Training
Actively engage in cross-functional teams within Biologics Development and provide support to external departments. Share scientific expertise openly and collaboratively to develop rational solutions to challenges.
Develop protocols and SOPs, train personnel, and uphold laboratory standards in alignment with departmental and company expectations. Understand, document, and adapt Quality Systems to correspond with the project stage (e.g., pre-development or development).
Maintain an up-to-date knowledge of scientific and technical literature relevant to the project and essential for the advancement of cutting-edge analytical methods, including the acquisition of necessary equipment.
Presentation and Advocacy
Deliver high-quality scientific presentations at internal management meetings, regional gatherings, and national conferences to enhance AbbVie’s reputation as a leader in the neuromodulator sector.
