Associate Scientist I/II, Biologics Drug Product Development

Company Description

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 Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

Job Description

The incumbent in this role will support the formulation development of protein biologics, with a specific focus on neurotoxins for therapeutics and aesthetic use.

This position requires laboratory work in areas requiring select agents and Toxins access (i.e., Biosafety level 2 laboratories). Access to and use of select agents is regulated by federal policies. Therefore, the candidate must conduct all work activities in compliance with AbbVie internal and applicable regulatory requirements. AbbVie internal requirements include compliance with ethics, environmental health and safety, financial, human resources, and general business policies, requirements, and objectives.

Responsibilities

• Execute formulation composition and drug product process development studies for sterile liquids, lyophilized, and pre-filled dosage forms.
• Manufacture drug product formulation batches for evaluating formulation stability and/or to support animal studies.
• 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 accordingly.
• Generate high-quality data based on sound scientific understanding 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.

Qualifications

• BS with a minimum of 3-5 years or MS with a minimum of 0-2 years of experience in pharmaceutics, pharmaceutical sciences, chemical engineering, analytical sciences, or equivalent field 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. Must be highly organized and detail oriented.
• Hands-on experience with analytical techniques used for protein characterization and stability studies (e.g HPLC, spectroscopy, HIAC, MFI, DLS, ELISA, Karl Fisher) are good to have.
• Prior experience with drug product manufacture processes and lyophilization is desirable.
• Excellent communication skills are required.
• Can hire in at either level depending on experience.

Additional Information

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 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.