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Associate Scientist / Scientist, NBE Formulation Development

Employer
AbbVie
Location
Lake County, Illinois
Start date
Aug 18, 2021

View more

Discipline
Science/R&D, Biotechnology
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
BioMidwest, Best Places to Work

Job Details

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.

The pharmaceutical development group for new biological entities (NBEs) develops antibody drug conjugates (ADC) and other biologics by state-of-the art formulation and analytical technologies. We create valuable intellectual property through new formulation compositions and cost effective manufacturing processes and prepare and defend CMC (Chemistry, Manufacturing and Control) regulatory content.

We are looking for a highly motivated person to support drug product Formulation and Process development. The candidate will support early-stage design and development of stable and robust drug product formulations and later-stage manufacturing process development for NBEs used in clinical trials and commercial product development. In this role, the candidate will be part of a global team and will work closely with scientists from multiple functional areas, including Analytical, and Process R&D, and Operations Science and Technology.

Key Responsibilities Include:

  • Support drug product formulation development and stability assessment activities of the assigned NBEs, including excipient screening and selection for clinical studies and commercialization of monoclonal antibodies, antibody drug conjugates, biospecifics, and fusion proteins.
  • 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, etc.) to develop robust formulations for frozen, refrigerated liquid, and lyophilized dosage forms.
  • Use a combination of theoretical models and experimental results to develop a robust drug product manufacturing control strategy.
  • Author relevant regulatory documents including the IND and BLA.
  • Prepare concise and sound scientific presentations of experimental results to management team and assist in authoring detailed scientific technical reports.
  • Stay current with the scientific literature and support new scientific initiatives.   

Qualifications

Qualifications

  • BS or MS in a scientific field and typically 5-7+ (BS) or 2-5+ (MS) years of relevant experience. Position will be hired based on experience.
  • Extensive hands on expertise using analytical methods for chemical and structural characterization of protein pharmaceuticals e.g. HPLC, UPLC, capillary electrophoresis, particle analysis, and other biophysical techniques (UV-vis, DLS, DSC, etc.) for protein characterization is a requirement.
  • Scientific understanding of the structure & function of monoclonal antibodies, antibody constructs/conjugates, bispecifics, and fusion proteins and their modes of degradation/stabilization.
  • 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. 

Key Leadership 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
Yes, 10 % of the Time
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.

Company

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, and YouTube.

Stock Symbol: ABBV

Stock Exchange: NYSE

Company info
Website
Phone
1-800-255-5162
Location
1 North Waukegan Road
North Chicago
Illinois
60064
US

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