Senior Scientist I, Biologics Drug Product Development

3 weeks ago

Irvine, United States AbbVie, Inc Full time

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

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.

Qualifications

* Ph.D in Pharmaceutical Sciences, Chemical Engineering, Analytical Sciences, Biochemistry 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 chemistry, analytical development, and formulation development is required.
* Candidates with hands-on expertise in analytical techniques used for protein characterization and stability studies (e.g liquid chromatography (SEC, ion exchange, HIC), DSC, CD and Fluorescence spectroscopy, sub-visible particle characterization, DLS, Karl Fisher) will be preferred.
* Technical expertise and practical experience in lyophilization process development of proteins/biologics as well as solid-state characterization are highly desirable. Prior experience in aseptic manufacturing process development, scale up, and technical transfer is a strong plus.
* Preference to candidates with demonstrated experience in solving problems and driving innovation.
* Excellent communication and written skills are required.

Additional Information

Applicable only to applicants

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