Senior Scientist I / II

Allergan; North Chicago (IL); On-site; USD 120,000 - 160,000; Full time

Job summary

AbbVie, located in North Chicago, IL, seeks a Senior Scientist I/II in Biologics Drug Product Development to lead formulation and process development, with collaboration across discovery, analytical and bioprocess teams.

The role requires hands-on experience in biologics formulation, DoE, and regulatory interactions, with opportunities to drive innovation and technology transfer to manufacturing sites.

Qualifications

• Bachelor's Degree or equivalent education and typically 10 years of experience.
• Master's Degree or equivalent education and typically 8 years of experience.
• PhD 0+ years of industry experience.

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.

Skills

Biologics formulation

Analytical characterization

Biophysical characterization

Degradation mechanisms

Stabilization strategies

DoE

Multivariate statistics

Data visualization

Education

Bachelor's degree

Master's degree

PhD

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,XandYouTube.

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 and genetic medicine (proteins, conjugates, peptides etc.).

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.

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

This position can be hired at Sr. Scientist I or II depending on education and years of experience.

Qualifications for Sr. Scientist I:

• Bachelor's Degree or equivalent education and typically 10 years of experience, Master's Degree or equivalent education and typically 8 years of experience, PhD 0+ years of industry experience.
• Proven ability to solve critical scientific problems.
• Hands-on experience with biologics formulation development.
• Hands-on experience with analytical and biophysical characterization of proteins 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.

Highly Preferred Qualifications:

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

Qualifications for the Sr. Scientist II:

• Senior Scientist II: 12+ (Bachelors), 10+ (Masters), or 4+ (PhD) years of relevant industry experience.
• Proven ability to solve critical scientific problems.
• Experience with biologics (proteins, conjugates, peptides and/or neurotoxins), parenteral synthetic molecules and/or genetic medicine (AAV, LNPs, cell therapy) drug product process development.
• Experience with sterile manufacturing unit operations (freeze-thaw, compounding, mixing, filtration and filling, lyophilization), characterization, scale-down models, simulation, scale-up, technology transfer, and batch record authoring.
• Hand-on experience with authoring regulatory filings for biologics and sterile parenteral products
• Experienceleading drug product development as the functional lead within cross-functional teams

Preferred Qualifications:

• Biologics drug product formulation development
• Understanding of relevant cGMP and regulatory guidance for biologics and sterile parenteral products
• Experience in managing third party manufacturers of sterile parenteral products
• Experience with quality risk management and control strategies for biologics and sterile parenteral products

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state orlocal 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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https://www.abbvie.com/join-us/reasonable-accommodations.html