Principal Research Scientist, Cell Culture Group Leader
The Manufacturing Sciences organization within Operations leads the optimization, validation, implementation, continuous improvement and global technical support for late-stage and commercial manufacturing of therapeutic proteins for AbbVie. We have an exciting opportunity for a Group Leader of Cell Culture (Principal Research Scientist) position at the AbbVie BioResearch Center (ABC) based in Worcester, reporting to the Director, Manufacturing Sciences. The candidate will be managing the cell culture group within Manufacturing Sciences at the AbbVie Worcester, supporting late-stage clinical to global commercial biologics manufacturing as a part of the broader Science and Technology Biologics organization. The candidate will be managing a group of scientists/engineers with BS, MS, and Ph.D. degrees, responsible for validation, approval, robustness, global manufacturing support, characterization, improvement, process investigation, and trending. Additional responsibilities include global harmonization, equipment scale-up, troubleshooting, and support to third party API manufacturing. Regulatory support responsibilities include authoring relevant sections of submissions and providing technical leadership for agency inspections, inquiries and audits. The candidate is expected to develop, communicate, and implement the vision and strategy for the group. In addition, the candidate is required to identify and drive technical innovations that will contribute to future business developments and improvements. The position will work with local Manufacturing and Quality organizations as well as with the broader Science and Technology Biologics organization and with global Regulatory, Quality and Manufacturing to improve process efficiency, robustness and product quality for AbbVie biologics globally. Routine technical analysis and advice on major programs is required to senior management. The candidate is also expected to mentor and enhance staff performance and to create a scientific climate of excellence to achieve business goals.
- Develops and achieves discipline strategy in alignment with functional goals and key technical objectives. Collaborates with experts within organization to integrate technical and business objectives into activities associated with development of new/commercial products or technology.
- Advances technical expertise within function. Proactively advises and shares knowledge with subordinates, peers, and senior management. Mentors and trains functional colleagues and assesses current and emerging business challenges enabling functional goal achievement.
- Ensures quality and effectiveness of key results of major project plans within function through sound design, early risk assessments, and implementation of fallback strategies.
- Sources and identifies emerging technical trends from internal/external sources and assess relevance. Integrates trends into functional short-term objectives. Advances cross-discipline technology and direction.
- Presents scientific concepts and results for functional scientific and non-scientific leaders as well as potential and existing partners.
- Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
- BS, MS, or PhD in Chemical Engineering or closely related field with typically 16+ years (BS), 14+ years (MS) or 8+ (PhD) years of postdoc or industry related experience.
- Ph.D. in Chemical Engineering with 9+ years of relevant experience in the biopharmaceutical industry is preferred.
- Outstanding record of accomplishment in areas of cell culture bioprocess development, improvement, validation, regulatory submissions, process robustness, manufacturing support and scale-up.
- Experience and insight into the regulatory process for drug approval as well advanced technical writing for submissions are required.
- Experience in managing technical professionals is required.
- Excellent communication, writing and presentation skills are expected.
- Interacts well with diverse groups within function and maintains strong working relationships with internal, global, and external collaborators.
- Demonstrated skills of independent thought and creativity in science and engineering.
- Demonstrated success in coordinating and executing important projects to achieve business unit goals.
- Ability to manage change initiatives, engineers and scientists in demanding situations and to work effectively in a highly collaborative and dynamic environment.
- Must have a “results-oriented” work ethic and a positive, “can-do” attitude with a strong sense of urgency and self-motivated desire to achieve.