Scientist l/II, 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.

In this role, you will support the formulation development of protein biologics from early development (pre-clinical/First-In-Human candidates) through late stages of development, with a specific focus on neurotoxins for therapeutics and aesthetic use. Critical to the role is the ability to contribute to drug product formulation development, process development, analytical method development, and troubleshooting.

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.

Responsibilities

• Contributes to the execution of studies for screening formulation components to develop stable drug products (e.g., liquid in vial, lyophilized powders, spray-dried powders, pre-filled syringes) based on a sound understanding of therapeutic protein liabilities
• Contributes to critical studies for developing manufacturing processes with phase-appropriate control strategies for a range of drug products (e.g., liquid in vial, lyophilized/spray-dried powders, pre-filled syringes, long-acting injectables)
• Contributes to protein product characterization by utilizing chromatography (e.g., HPLC, UPLC, HIC, SEC, CEX, AEX, LC-MS) or bioassays (e.g., SPR (Surface Plasmon Resistance), qELISA and other anti-body-based assays) tools
• Conduct clinical in-use studies to guide dose solution administration
• Interpret results and draw conclusions from multistage experiments; note significant deviations and propose relevant new experiments
• Generate high-quality data based on sound scientific principles and prepare formulation data summaries, technical reports, and scientific presentations
• Support functional technical initiatives by investigating and developing novel experimental approaches and/or technologies in the field of drug product development
• Maintain oversight of day-to-day laboratory activities; manage inventory of raw materials and drug product packaging and manufacturing supplies; coordinate ordering, shipping, and receiving
• This position requires laboratory work in areas requiring select agents and Toxins access (i.e., Biosafety level 2 laboratories). Federal policies regulate access to and use of select agents. Therefore, the candidate must conduct all work activities in compliance with AbbVie's internal and applicable regulatory requirements. AbbVie's internal requirements include compliance with ethics, environmental health and safety, financial, human resources, and general business policies, requirements, and objectives.

• BS with a minimum of 5-7 years or MS with a minimum of 2-4 years of experience in pharmaceutics, pharmaceutical sciences, chemical engineering, analytical sciences, or equivalent fields in the biotechnology industry
• CMC development experience in protein formulation, drug delivery, or analytical functions is preferred
• Candidates must exhibit the technical ability to execute and troubleshoot experiments through rational and critical thinking. Candidates must be highly organized and detail oriented
• Hands-on experience (operation and method development) with some protein biophysical characterization tools is a must for this role including chromatography (e.g., HPLC, UPLC, HIC, SEC, CEX, AEX, LC-MS) and bioassays (e.g., SPR (Surface Plasmon Resistance), qELISA and other anti-body-based assays)
• Prior experience with drug product manufacture processes and lyophilization is a plus
• Excellent communication skills required

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 an equal opportunity employer and 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.

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