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Senior Principal Research Scientist, Biologics Analytical R&D

AbbVie
Irvine, California, United States
Full-time

Job Description

Join AbbVie as a Senior Principal Research Scientist and shape the future of neurotoxin biopharmaceuticals. AbbVie is seeking a highly skilled Senior Principal Research Scientist to join our Biologics Analytical R&D team in Irvine, CA.

With a focus on innovation and excellence, you'll play a key role in advancing our Neurotoxin Pipeline.

As a Senior Principal Research Scientist, you will collaborate with cross-functional development teams to support current and next-generation Neurotoxin Pipeline projects.

This role demands a forward-thinking professional who can develop analytical strategies for long-acting injectables, combination products, and sustained release formulations.

You will design customized strategies for each program to support the developability assessment of novel and genetically modified neurotoxins at nano-gram level protein concentrations.

Key Responsibilities :

  • Analytical Control Strategies : Employ both established and emerging analytical tools and next-generation technologies to create efficient, effective analytical strategies.
  • Strategic Development : Lead SMEs in developing fit-for-purpose methods for the neurotoxin product pipeline through early phase development.
  • Method Transfer : Ensure successful transfer of methods to late-phase development teams to support commercialization and robustness activities.
  • Molecule Characterization : Develop strategies to fully characterize various biologic molecules and formulations.
  • Early Development Support : Provide critical support in lead optimization, candidate nomination, and selection of novel and modified neurotoxins.
  • Formulation Support : Support Neurotoxins and recombinant Neurotoxins in variety of different formulations, drug delivery vehicles (nanoparticles, sustained release, etc.

and presentations (such as lyophilized, liquid, injectables etc.).

  • Method Optimization : Develop and optimize analytical methods to enable GLP Tox and early clinical material supplies.
  • Leadership Collaboration : Partner with leadership team to define analytical strategy, timelines, and objectives.
  • Capability Enhancement : Assess and integrate new analytical capabilities, ensuring that technical competencies remain contemporary and focused .
  • Regulatory Compliance : Operate in compliance with AbbVie internal policies and applicable regulatory requirements, especially in biosafety level 2 laboratories.

Qualifications

  • Ph.D. in Chemistry, Molecular Biology, Biochemistry, Biotechnology, or a related field, with a minimum of 12+ years of relevant experience.
  • 8 years of pharmaceutical industry experience is desired.
  • Proven track record in developing robust analytical strategies for complex biologics and combination products.
  • Deep understanding of therapeutic proteins and drug development across various biologics modalities; experience with gene and cell therapy is a plus.
  • Proficiency with LCMS / MS, CE-SDS, SDS-PAGE, Western blot, SEC, AEX, CEX, Particle size analysis, and other compendial techniques.
  • Experience in leading and collaborating with cross-functional project teams.
  • Excellent ability to convey complex scientific concepts effectively.
  • Strategic thinker passionate about innovation and committed to staying at the forefront of scientific advancements.
  • This position requires the individual to work in areas requiring select agents and toxins access (i.e. Biosafety level 2 laboratories).

Access to and use of select agents is 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.

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 in good faith it will pay for this role at the time of this posting based on the job grade for this position.

Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less 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 / vision insurance and 401(k) to eligible employees.

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

This job is eligible to participate in our long-term incentive programs

Note : No amount of pay is considered to be wages 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 benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.

AbbVie is an equal opportunity employer and 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.

US & Puerto Rico only - to learn more, visit https : / / www.abbvie.com / join-us / equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more :

https : / / www.abbvie.com / join-us / reasonable-accommodations.html

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