Principal Research Scientist I, Biologics Analytical R&D - Separation

AbbVie - Irvine, CA

Full-time - Principal

Irvine, CA

Chemical Manufacturing

About the position

The Principal Research Scientist I in Biologics Analytical R&D at AbbVie is a pivotal role that involves leading the development, qualification, transfer, and validation of analytical methods for the analysis and characterization of neurotoxin and biologics entities. This position requires a high level of independence, as the individual will plan experimental work and execute protocols that support biologics process development, formulation development, and stability studies. The scientist will generate, compile, and evaluate data for technical reports that are essential for regulatory filings for both new and currently marketed biological products. Additionally, the role includes writing sections or subsections of technical reports and standard operating procedures (SOPs). The Principal Research Scientist will carry out multiple analytical methods to support AbbVie biologics projects, adapting to departmental needs. A significant aspect of this role is maintaining a productive and collaborative laboratory environment that aligns with regulatory and company expectations. The position also involves working in areas that require access to select agents and toxins, necessitating compliance with federal policies and AbbVie’s internal requirements, including ethics, environmental health and safety, and general business policies. Key responsibilities include leading the development of phase-appropriate separation methods for toxin development programs, executing the development and validation of analytical methods for biopharmaceuticals, creating written procedures and protocols, and representing the department in organization-wide initiatives. The scientist will apply both routine and specialized analytical techniques to characterize and quantify biopharmaceuticals, maintain laboratory supplies, and ensure quality methods are delivered in a timely manner. Furthermore, the role involves active participation in cross-functional teams, sharing scientific expertise, developing protocols and SOPs, and training staff to maintain laboratory standards. The individual will also be responsible for making high-quality scientific presentations and defending product data to regulatory agencies, as well as evaluating the performance of direct reports and assisting in their development.

Responsibilities

• Lead development of phase appropriate separation methods to support toxin development programs at various phases by managing direct reports.
• Execute the development and validation of analytical methods for the analysis and characterization of biopharmaceuticals.
• Create written procedures and protocols.
• Transfer, qualify or validate methods as needed.
• Represent department for important organization-wide initiatives to support establishment of infrastructures.
• Apply routine and specialized analytical techniques to characterize and quantify biopharmaceuticals.
• Maintain reagent supplies, notebooks, summarize results in written reports and communicate observations to ensure that the end user receives quality methods in a timely manner.
• Comply with Quality Principles related to data generation and reporting.
• Actively participate on cross-functional teams within Biologics Development and provide support to external departments.
• Openly share scientific expertise and collaboratively help the team to formulate rational solutions to problems.
• Develop protocols and SOPs, train staff and maintain the laboratory consistent with departmental and company requirements.
• Understand, document, and adjust Quality Systems to match the project stage (e.g. pre-development or development).
• Maintain a good and current knowledge of the scientific and technical literature pertinent to the project and necessary for development of state-of-the-art analytical methods, including the acquisition of necessary equipment.
• Keep up-to-date on current and cutting-edge developments in the biologics characterization field.
• Make high quality scientific presentations at internal management, regional and national meetings to help advance AbbVie's image as the thought and product leader in the neuromodulator field.
• Present and defend product, assay and process data to regulatory agencies.
• Make staffing recommendations related to direct reports and communicate desired forward path to mid-and-senior level management for endorsement/implementation.
• Evaluate performance for direct reports and assist with staff development via recommendations for internal and external technical training and scientific conferences.

Requirements

• BS or equivalent education and extensive, typically 14+ years of experience; MS or equivalent education with typically 12+ years of experience; PhD with typically 6+ years of experience in area or scientific area of discipline.
• Advanced knowledge and experience in developing, validating and transferring separation methods for biologics, including HPLC (RP, SEC, HIC, IEX), gel and capillary electrophoresis (SDS-PAGE, native-PAGE, CE, cIEF).
• Strong analytical and instrument skills and a thorough understanding and working knowledge of analytical method development and validation.
• Solid understanding of methods and procedures related to the production and characterization of biopharmaceuticals in a regulated environment.
• Extensive working knowledge of the requirements of working in a cGMP/GSP environment is desired.
• Prior experience of supervising staff is highly desired.
• Thorough understanding in CMC development strategy of biologics drugs is expected.

Benefits

• 401(k)
• Dental insurance
• Health insurance
• Paid time off
• Vision insurance