Senior Scientist I, Biologics Drug Product Development

3 weeks ago

Hamilton, Canada Allergan 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 atwww.abbvie.com. Follow @abbvie onTwitter,Facebook,Instagram,YouTubeandLinkedIn.


Job Description

The Development Sciences Biologics Drug Product Development organization within AbbVie develops and characterizes drug product formulations and manufacturing processes to provide clinical dosage forms to enable the development of AbbVie’s pipeline. AbbVie is seeking a highly motivated person to support drug product Preformulation and Formulation development. The candidate will support both the early-stage assessment of candidates coming out of the Discovery pipeline and the design and development of stable drug product formulation and manufacturing processes for biologics used in clinical trials. In addition, the candidate will be expected to drive key scientific initiatives and lead innovative approaches to improve current workflows. In this role, the candidate will be a member 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:

  • Drive key scientific initiatives related to pre-formulation and lead innovative approaches to assess CMC risks.
  • Lead pre-formulation assessment activities, including candidate screening and selection for clinical studies of monoclonal antibodies, antibody drug conjugates, bispecific antibodies, and fusion proteins.
  • Design and execute studies evaluating the chemical and physical stability 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). 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 management and author detailed scientific technical reports.
  • Stay current with the scientific literature and lead new scientific initiatives. Publish and present findings externally in peer reviewed journals and industrial conferences.

Qualifications
  • PhD in Biochemistry, Chemistry, Pharmaceutical Chemistry or related field and zero years of related work experience; MS in Biochemistry, Chemistry, Pharmaceutical Chemistry or related field and five years of related work experience; BS in Biochemistry, Chemistry, Pharmaceutical Chemistry or related field and seven years of related work 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).
  • 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.
  • Desire to drive scientific initiatives and become a scientific SME in protein characterization and stability.

Key Competencies:

  • Builds strong relationships with peers and cross functionally with partners outside of the team to enable higher performance.
  • Excellent oral communication skills and 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.

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:

  • The compensation range described below is the range of possible base pay compensation that the Company believes ingood faith it will pay for this role at the time of this postingbased on the job grade for this position. Individualcompensation paid within this range will depend on many factors including geographic location, and we may ultimatelypay more orless than the posted range. This range may be modified in the future.

  • We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/visioninsurance and 401(k) to eligible employees.

  • This job is eligible to participate in our short-term incentive programs.

Note: No amount of payis a considered to bewages or compensation until such amount is earned, vested, and determinable.The amount and availability of any bonus, commission,incentive, benefits, or any other form of compensation and benefitsthat are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paidandmay be modified at the Company’s sole and absolute discretion, consistent with applicable law.

AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because 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, status as a protected veteran, or any other legally protected group status.

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