Senior Scientist I, Biologics Drug Product Development

North Chicago, IL, United Statesfull time

On Site

senior

H1B: yes

AbbVie The Senior Scientist I in Biologics Drug Product Development at AbbVie leads formulation and process development for biologics and genetic medicines. The role involves biophysical characterization, scale-up support, and collaboration with cross-functional teams.

Responsibilities

Develop and apply biophysical characterization strategies to assess molecular properties, stability, aggregation, and formulation performance to support product development decisions.
Apply a strong understanding of the formulation and analytical challenges associated with ultra-high-concentration biologics and co-formulations, including their impact on stability, viscosity, manufacturability, and product performance.
Support scale-up and technology transfer activities to internal and external manufacturing sites.
Utilize automation and high throughput screening technologies to accelerate biologics formulation development and enable efficient evaluation of multiple formulation variables.
Lead the design and execution of biologics drug product formulation and process development, characterization and robustness studies.
Keep abreast of the latest advances in biologics formulation and process technologies.
Initiate and/or support scientific initiatives to drive innovation, continuously enhance capabilities and improve business processes.
May represent the Bio DPD function in the cross-functional Product Presentation and Device Strategy Team (PPDST) and the CMC team.
Effectively and timely communicates study plans, risks and mitigation plans to stakeholder and line management.
Bachelors, Masters, or PhD in pharmaceutics, pharmaceutical sciences, chemistry, chemical engineering, or related disciplines with 8+ (Bachelors), 6+ (Masters), or 0-4+ (PhD) years of relevant industry experience, is required.
Proven ability to solve critical scientific problems.
Hands-on experience with biologics formulation development and lyophilization.

Qualification

Bachelors8+ years experience for Bachelors

Required

Bachelors, Masters, or PhD in pharmaceutics, pharmaceutical sciences, chemistry, chemical engineering, or related disciplines
8+ years experience for Bachelors, 6+ years for Masters

Preferred

Understanding of relevant cGMP and regulatory guidance.
Experience with sterile manufacturing unit operations (freeze-thaw, mixing, filtration, filling, and freeze-drying) development, characterization, scale-up and technology transfer.
Experience in managing third party manufacturers.
Experience with quality risk management and drug product control strategies.
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.