AbbVie

Senior Scientist I, Biologics Drug Product Development

Employer
AbbVie
Location
Lake County, IL, United States
Posted
Feb 25, 2021
Ref
2103147
Required Education
Doctorate/PHD/MD
Position Type
Full time
About AbbVie
AbbVie's mission is to discover and deliver innovative medicines 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, eye care, virology, women's health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on Twitter , Facebook , Instagram , YouTube and LinkedIn .

Overview
The Development Sciences Drug Product Development (DevSci DPD) organization within AbbVie develops and characterizes drug product formulations, combination products, and manufacturing processes to provide clinical dosage forms and devices to enable the development of AbbVie's pipeline, and ultimately to provide commercial drug products, combination products, and commercial manufacturing processes.

AbbVie is seeking a highly motivated person to support drug product Preformulation and Formulation development. The candidate will support early-stage assessment of candidates coming out of the Discovery pipeline, as well as the design and development of stable and robust drug product formulation and manufacturing processes for NBEs used in clinical trials and commercial. In this role, the candidate will be part of a global team and will work closely with scientists from multiple functional areas, including Discovery, Analytical, Process R&D, and Manufacturing Science & Technology.

Key Responsibilities:
  • Lead the formulation, drug product development and stability assessment activities of the assigned NBEs, including candidate screening and selection for clinical studies and commercialization of monoclonal antibodies, antibody drug conjugates, bispecifics, and fusion proteins.
  • Design and execute studies evaluating the stability (chemical & physical) of biologics against solution conditions (pH, ionic strength, temperature, light etc.) and physical stresses arising from manufacturing process conditions (freeze thaw, mixing, filtration, filling, and lyophilization), and screen excipients (buffers, stabilizers, surfactants, tonicity & Tg' modifiers etc.) to develop robust formulations for refrigerated liquid and lyophilized dosage forms.
  • Prepare concise and sound scientific presentations of experimental results to the management and author detailed scientific technical reports.
  • Generate original technical ideas for formulation and analytical technologies of assigned NBE development projects.
  • Stay current with the scientific literature and lead new scientific initiatives.

Qualifications

Qualifications:
  • PhD in Chemistry or related field and typically 0-2 years of relevant experience.
  • MS in Chemistry or related field with typically 8 years of relevant experience.
  • BS in Chemistry or related field with typically 10 years of experience.
  • Scientific understanding of the structure & function of monoclonal antibodies, antibody constructs/conjugates, bispecifics and fusion proteins and their modes of degradation/stabilization.
  • Solid understanding of the scientific approaches to develop commercially viable protein drug products.
  • Strong laboratory skills focused on formulation development for monoclonal antibodies and antibody constructs/conjugates (standard excipient selection, functional excipients, high throughput assays).
  • Solid understanding of the various unit operations of aseptic manufacturing such as bulk freeze thaw, compounding/mixing, filtration, filling, and lyophilization for liquid and lyophilized NBEs.
  • Extensive hands-on expertise of analytical methods for chemical and structural characterization of protein pharmaceuticals e.g. HPLC, UPLC, capillary electrophoresis and biophysical techniques (UV-vis, DLS, DSC, Fluorescence, particle analysis, etc.) for protein characterization.

Key Competencies:
  • Builds strong relationships with peers and cross functionally with partners outside of the team to enable higher performance.
  • Excellent oral communication skills in a scientific setting as well as sound technical writing and documentation competencies are required.
  • The candidate must be able to work independently, respond to changing priorities and short lead times for multiple tasks; able to identify problems and work toward solutions.
  • Raises the bar and is never satisfied with the status quo.
  • Creates a learning environment, open to suggestions and experimentation for improvement.
  • Embraces the ideas of others, nurtures innovation and manages innovation to reality.

Significant Work Activities
N/A
Travel
No
Job Type
Experienced
Schedule
Full-time
Job Level Code
IC
Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis 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, protected veteran status, or any other legally protected characteristic.