Principal Research Scientist, Biologics Discovery and Pre-Formulation
December 10, 2013
AbbVie (NYSE:ABBV) is a global, research-based biopharmaceutical company formed in 2013 following separation from Abbott. AbbVie combines the focus and passion of a leading-edge biotech with the expertise and capabilities of a long-established pharmaceutical leader to develop and market advanced therapies that address some of the world’s most complex and serious diseases. AbbVie will employ 21,000 people worldwide and markets medicines in more than 170 countries.
Primary Job Function
To assure adequate quality of its biologics lead candidates to enter development, AbbVie’s dedicated a Discovery Support and Preformulation group within the Drug Product Development Department. This unit is well integrated in AbbVie’sbiologics candidates screening and lead molecule identification process.
AbbVie is looking for a highly experienced individual as a group head, who will continue to shape and lead the unit. She/he will manage a team of five senior scientist experts. The position is highly strategic and visible within the discovery and development organizations. She /he is reporting to the Head of Drug Product Formulation Development in Germany and is interfacing with on-site functions such as Molecule engineering, Drug Metabolism and Pharmacokinetics, Analytical Development, Drug Substance Manufacturing & Process Development, Pharmacology, Project and CMC-Management, Legal and lP etc.
A further key interface is the Drug Product site in Ludwigshafen, German, in particular the Formulation & Process Development as well as the Project Management functions.
The job is based in Worcester, MA USA at the AbbVies Bioresearch Center, a central hub within AbbVie, focused on development of new biologic entities.
Sets discipline strategy in alignment with functional goals and key scientific objectives to achieve functional goals.
Develops key scientific objective and collaborates with partner functions to integrate scientific objectives into activities associated with development of new/improved technologies to support drug like-properties assessment of antibodies, bispecific antibodies (DVD-IgTM) and antibody drug conjugates (ADC).
Advances scientific expertise within function to create an environment of innovation by fostering knowledge sharing and utilizing the expertise in the group. Proactively provide relevant information to peers, and senior management.
Develops network valued by functional leaders. Actively supports open exchange of expert discipline knowledge. Deepens insight to better assess current and emerging business challenges enabling functional goal achievement and continuously adjust the strategy for the group.
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 scientific trends from multiple internal and external sources. Assesses relevance. Determines use for innovation. Integrates trends into functional short-term and mid-term objectives. Advances across-discipline technology and direction.
Applies imagination. Generates IP and/or institutional knowledge. Creates, invents, and implements new or better approaches, alternatives, and breakthrough ideas that are valued by customers within the function. Develops and advances existing and breakthrough technology.
Maintains external reputation of the group as discipline experts in the field of protein-protein interactions physicochemical characterization and and biologics lead identification. Influences industry with presentations, serving on panel discussions at industry meetings, attending industry meetings, or authoring articles for peer-reviewed publications. Collaboration with leading groups in academia
Develop and manage the organization (group, equipment and budget) and interfaces, so as to keep up-to-date methods, processes, resources, equipment and results consistent with Quality and EHS requirements.
Additional Responsibilities May Include
Provides advice and counsel with respect to regulatory strategy. Collaborates with internal regulatory experts to ensure compliance with schedules for NDAs/INDs/sNDAs and INDA submissions
Selects, builds and maintains the most appropriate vendor partnerships. Evaluates vendor reliability and performance ensuring adherence to plans, policies, and procedures to provide required products or services.
Establishes collaborative relationships. Manages conflicts. Achieves compromise. Ensures the multiple discipline, functional team is making good decisions regarding design, materials, manufacturing, quality, costs, regulatory compliance, intellectual property, and strategic fit within the patent portfolio.
In negotiations, gathers and understands the relevant facts supporting optimal decisions where value or resources are not left on the table, risks can be pro-actively managed, and desired ongoing partnerships and longstanding relationships are the result.
Develops strong awareness of other disciplines/subsystems’ dependencies and challenges. Appropriately modifies own strategy and performance goals to avoid performance tradeoffs.
Excellent scientific level: Ph.D. Pharmaceutical Sciences, with a specialization in physical chemistry, solution chemistry, interface and colloidal sciences of proteins (Minimum : Ph.D. in Sciences)
8-10 years professional experience in biologics drug product development or equivalent work experience and experience in supervising a team.
High level of leadership within a complex, international, multidisciplinary environment and awareness of management and coordination techniques for multi-site organizations
In-depth knowledge and experience with analytical techniques necessary for the evaluation of physicochemical properties of new biological entities such as bispecific antibodies and/or antibody drug conjugates in a high-throughput setting, is mandatory. The successful candidate should be an expert in characterization of protein-protein interactions, protein stability and protein structures using techniques such as light scattering, differential scanning calorimetry, fluorescence, ultraviolet spectrophotometry, fourier transform infrared spectroscopy and circular dichroism. Ideally, the candidate has experience with high-throughput screening methods and automatic liquid handling systems.
Due to close interactions with multiple partner functions such as biologics drug discovery, drug product formulation and drug substance manufacturing, excellent communication skills as well as knowledge and experience with protein formulation, lyophilization, and protein-protein as well as protein-excipient interactions is mandatory.
The ideal candidate works well with other discipline experts and leaders within the function in a collaborative, fast paced goal-driven environment by using interpersonal skills to negotiate & reconcile interdisciplinary differences optimizing overall functional goals.
Experience with electronic data tracking and bioinformatics systems such as electronic lab notebook, molecule databases etc. would be a significant plus.