Scientist l - 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 X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.

Job Description

The Scientist I - Biologics Drug Product Development will support the formulation development of protein biologics from early development (pre-clinical/First-In-Human candidates), 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.

• 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.

Qualifications

Minimum Qualifications:

• Bachelors with a minimum of 5-7 years OR Masters with a minimum of 2-4 years of experience in pharmaceutics, pharmaceutical sciences, chemical engineering, analytical sciences, or equivalent field in the biotechnology industry

• Experience with formulations in particular

• Hands-on experience with analytical techniques used for protein characterization and stability studies (e.g HPLC, spectroscopy, SEC, HIAC, MFI, DLS, ELISA, Karl Fisher).

Preferred Experience:

• Prior experience with drug product manufacture processes and lyophilization is a plus

• CMC development experience in protein formulation, drug delivery, or analytical functions is preferred.

Other Required Skills:

• Excellent communication skills required.

• Candidates must exhibit the technical ability to execute and troubleshoot experiments through rational and critical thinking.

• Candidates must be highly organized and detail oriented.

Additional Information

Applicable only to applicants