Senior Scientist I, Biologics Drug Product Development

Senior Scientist I Biologics Drug Product Development

Biologics Drug Product Development (Bio DPD) a part of Development Sciences within AbbVies R&D is a global organization that is responsible for drug product formulation and process development and definition of the product presentation for biologics (proteins conjugates peptides neurotoxins etc.) and genetic medicine (AAV LNPs Cell Therapy).

AbbVie is seeking a highly motivated candidate for the position of Senior Scientist I Biologics Drug Product Development located in North Chicago IL. We are seeking an accomplished scientist with a proven track record in biologics formulation and process development and characterization. This position will be an integral part of the product development and CMC teams and will have strong collaborations with several stakeholders including discovery research analytical research and development bioprocess development combination products development science and technology pilot plants and third-party manufacturers.

Key Responsibilities:

• Lead the design and execution of biologics drug product formulation and process development characterization and robustness studies.
• Support scale-up and technology transfer activities to internal and external manufacturing sites.
• 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.

Qualifications :

Required Qualifications:

• Bachelors Masters or PhD in pharmaceutics pharmaceutical sciences chemistry chemical engineering or related disciplines with 8 (Bachelors) 6 (Masters) or 0 (PhD) years of relevant industry experience.
• Proven ability to solve critical scientific problems.
• Hands-on experience with biologics formulation development and lyophilization.
• Hands-on experience with analytical and biophysical characterization of proteins (e.g. HPLC/UPLC UV-Vis spectroscopy CE-SDS icIEF HIAC MFI DLS DSC etc) and solid-state characterization methods.
• Solid understanding of biologics degradation mechanisms and stabilization strategies.
• Hands-on experience with Design of Experiments (DoE) multivariate statistical analyses and data visualization tools

Preferred Qualifications:

• 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.

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. 

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 Companys sole and absolute discretion unless and until paid and may be modified at the Companys 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 and serving our community. Equal Opportunity Employer/Veterans/Disabled. 

US & Puerto Rico only - to learn more visit  & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:

Work :

No