Company DescriptionAbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job DescriptionAssociate Scientist I/II, CMC Biologics Drug Product DevelopmentThe Biologics Drug Product Development group develops antibody drug conjugates (ADC) and other biologics by state-of-the-art formulation and analytical technologies. We create valuable intellectual property through new formulation compositions and prepare and defend CMC (Chemistry, Manufacturing and Control) regulatory content.We are looking for a highly motivated person to support drug product Preformulation and Formulation development. The candidate will support early-stage assessment of candidates coming out of the Discovery pipeline, as well as the design and development of stable and robust drug product formulations for biologic entities used in clinical trials. In this role, the candidate will be part of a global team and will work closely with scientists from multiple functional areas, including Discovery, Analytical, and Process R&D.Key Responsibilities Include:
Execute the Preformulation developability assessments of diverse biologic modalities (monoclonal antibodies, antibody drug conjugates, bispecifics, and fusion proteins) to support candidate screening and selection.
Support Formulation development activities to enable first-in-human clinical studies.
Execute studies evaluating the stability (chemical & physical) of biologics against solution conditions (pH, ionic strength, temperature, light, etc.) and physical stresses arising from manufacturing process conditions (freeze thaw, mixing, filtration, filling, and lyophilization), and screen excipients (buffers, stabilizers, surfactants, etc.) to develop robust formulations for frozen, refrigerated liquid, and lyophilized dosage forms.
Perform lab-based studies including study design, preparation, execution, data collection, analysis, presentation, and report writing.
Prepare concise and sound scientific presentations of experimental results to management and assist in authoring detailed scientific technical reports.
Qualifications
Associate Scientist I: BS in a scientific field
Associate Scientist II: BS or MS in a scientific field and typically 3 (BS) or 0 (MS) years of relevant experience
Hands-on experience using analytical methods for chemical and structural characterization of proteins e.g. chromatography, capillary electrophoresis, particle analysis, and other biophysical techniques (UV-vis, DLS, DSC, etc.) for protein characterization.
Scientific problem solving, experimental design, and trouble shooting skills.
Scientific understanding of the structure & function of monoclonal antibodies, antibody constructs/conjugates, bispecifics, and fusion proteins and their modes of degradation/stabilization.
Key Leadership Competencies:
Builds strong relationships with peers and cross functionally with partners outside of the team to enable higher performance.
Excellent oral communication skills in a scientific setting, as well as sound technical writing and documentation competencies are required.
The candidate must be able to work independently, respond to changing priorities and short lead times for multiple tasks; able to identify problems and work toward solutions.
Raises the bar and is never satisfied with the status quo.
Creates a learning environment, open to suggestions and experimentation for improvement.
Embraces the ideas of others, nurtures innovation and manages innovation to reality.
Additional InformationApplicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
This job is eligible to participate in our short-term incentive programs.
Note: No amount of pay is a considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law. AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.