Senior Scientist I, Biologics Drug Product Development

AbbVie'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.

Within the Biologics CMC Development organization, the Senior Scientist I will support the formulation development, manufacturing process and testing of protein Biologics Drug Products from early development through commercialization, with a specific focus on neurotoxins for therapeutics and aesthetic use. This role will focus on developing analytical screening tools for formulations screening to optimize drug stability. Key to this role is the ability to develop scientific strategies, navigate challenges, and oversee the work of matrixed resources. This is an exciting opportunity to join a dynamic and collaborative Drug Product Development team to bring novel neurotoxins-based therapies and products to our patients.

The ideal candidate will have hands-on experience in analytical techniques used for protein characterization and stability testing and a demonstrated ability to drive innovative science in a team setting.

Responsibilities

• Plans and executes product formulation & process development activities in support of the development of new products intended for new biologic entities and life-cycle management of marketed products with a focus on neurotoxin biologic Drug Products.


• Develop analytical screening tools for screening formulations to develop stable Drug Products based on a sound understanding of therapeutic protein liabilities.


• Generate high-quality data based on sound scientific principles and prepare formulation data summaries, technical reports, scientific presentations, and regulatory documents.


• Participate in Drug Product Development teams and contribute to the planning and execution of Product Development studies including formulation and Drug Product process development, based on project goals and timelines.


• Actively interact with CMC members and other AbbVie stakeholders to enable the successful development of AbbVie Drug Products.


• Drive innovation by investigating and developing novel experimental approaches and/or technologies in the field of Drug Product Development and raise visibility within the scientific community through external presentations and publications.

Qualifications

• Ph.D. in Pharmaceutical Sciences, Analytical Sciences, Biochemistry and Molecular Biology, chemical engineering, or equivalent field with 0-3 years of experience or BS/MS degree with 8-10 years of relevant experience in the biotechnology or pharmaceutical industry.


• A strong technical background encompassing protein formulation principle, Drug Product degradation pathways, and characterization approaches is required.


• Candidates with hands-on experience in analytical techniques used for protein characterization and stability testing will be preferred (e.g., Chromatography (Reverse phase, Size exclusion, Ion exchange chromatography, Hydrophobic interaction chromatography), Spectroscopy techniques (UV-absorbance, fluorescence etc), Scattering techniques (Dynamic light Scattering, X-ray scattering etc), Particle Analysis (sub micrometer, micrometer and visible particle analysis), Calorimetry (Differential scanning calorimetry (DSC), nano-DSC), ELISA and Pull down assays.


• Prior experience in the development of protein product formulations and lyophilization expertise is highly desirable. Prior experience in cell-based assays & Surface Plasmon Resonance is preferred.


• Prior experience with aseptic processing and Drug Product manufacturing process transfer is preferred.


• Candidates must be detail-oriented and highly organized.


• Demonstrated ability to drive innovative science and solve complex problems is highly preferred.


• Excellent communication and written skills are required.

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Applicable 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 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.