Senior Scientist I, Biologics Drug Product Development

Job Description
The incumbent in this role will support the formulation development of protein biologics from early development through commercialization, 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 and use of select agents is highly 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
Develop preclinical and clinical formulations, including liquid and lyophilized dosage forms, and related drug product manufacturing processes.
Transfer drug product manufacturing process to internal and external fill-finish facilities and provide on-site support as needed.
Design lyophilization cycle studies for drug product manufacturing and optimize developed lyophilization cycle processes to manufacture freeze-dried drug products.
Support development stability and clinical in-use studies to guide dose solution administration.
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.