Senior Scientist I, Biologics Drug Product Development

AbbVie Inc.; Chicago (IL); On-site; USD 120,000 - 180,000; Full time

Job summary

AbbVie in North Chicago, IL, seeks a Senior Scientist I in Biologics Drug Product Development to lead formulation development and characterization efforts across development stages.

You will apply DoE methods, work with analytical teams, and collaborate with discovery research and manufacturing to ensure robust product presentation and technology transfer to internal and external sites.

Qualifications

• 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.
• Hands-on experience with analytical and biophysical characterization of proteins and solid-state characterization methods.
• Experience with automation technologies and/or high-throughput screening methods for formulation development.
• Solid understanding of biologics degradation mechanisms and stabilization strategies.
• Hands-on experience with Design of Experiments (DoE), multivariate statistical analyses and data visualization tools.

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.

Job description

Company Description

About AbbVie

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 including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

Job Description

Biologics Drug Product Development (Bio DPD), a part of Development Sciences within AbbVie’s 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, 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:

• 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.

Qualifications

• 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.
• Hands-on experience with analytical and biophysical characterization of proteins and solid-state characterization methods.
• Experience with automation technologies and/or high-throughput screening methods for formulation development.
• 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 Companybelieves ingood faith it will pay for this role at thetimeofthis posting based on the job grade for this position.Individualcompensation paid within this range will depend on many factors including geographiclocation,andwemayultimatelypaymore or less than the posted range. This range may bemodifiedin thefuture.
• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick),medical/dental/visioninsurance and 401(k) to eligibleemployees.
• This job is eligible toparticipatein our short-term incentiveprograms.

Note: No amount of payis considered to bewages or compensation until such amount is earned, vested, anddeterminable.Theamountandavailabilityof anybonus,commission, incentive, benefits, or any other form ofcompensation and benefitsthat are allocable to a particular employeeremainsin the Company’ssoleandabsolutediscretion unless and until paid andmay bemodifiedat the Company’s sole and absolute discretion, consistent withapplicable 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 https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

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