Principal Research Scientist II, Biologics Drug Product Development jobs in United States
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AbbVie · 14 hours ago

Principal Research Scientist II, Biologics Drug Product Development

AbbVie is a company dedicated to discovering and delivering innovative medicines that address serious health issues. They are seeking a Principal Research Scientist II to lead biologics drug product process development and collaborate with various teams in the product development lifecycle.

BiotechnologyFinancial ServicesHealth CareMedicalPharmaceuticalVenture Capital
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Comp. & Benefits
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H1B Sponsor Likelynote

Responsibilities

Lead the early-stage biologics drug product process development group in Lake County, IL
Accountable for drug product process development, scale-down modeling, process simulation, manufacture of technical batches, and process scale-up and tech transfer for early-stage biologics and sterile parenteral programs
Initiate and/or support scientific initiatives to drive innovation, continuously enhance capabilities and platforms, and improve business processes
Serve as a drug product team leader for one or more projects and represents Bio DPD in the cross-functional Product Presentation and Device Strategy Team (PPDST) and the CMC Team
Effectively and timely communicate development plans, risks, and mitigation plans to stakeholders and line management
Support due diligence for business development opportunities
Manage a team of 4-5 scientists and engineers (BSc to PhD level) including other drug product team leaders
Responsible for performance management, development plans, and recommendations for promotions and transfers for direct reports

Qualification

Biologics drug product developmentProcess scale-upTech transferSterile manufacturing operationsRegulatory filings authoringPeople managementQuality risk managementInnovation managementProblem solvingCross-functional leadershipCommunication skills

Required

Bachelors, Masters, or PhD in Pharmaceutics, Pharmaceutical Sciences, Chemistry, Chemical Engineering, or related disciplines with 16+ (Bachelors), 14+ (Masters), or 8+ (PhD) years of relevant industry experience
Proven ability to solve critical scientific problems
Strong experience with biologics (proteins, conjugates, peptides and/or neurotoxins), parenteral synthetic molecules and/or genetic medicine (AAV, LNPs, cell therapy) drug product process development
Extensive experience with sterile manufacturing unit operations (freeze-thaw, compounding, mixing, filtration and filling) characterization, scale-down models, simulation, scale-up, technology transfer, and batch record authoring
Experience as CMC cross-functional matrix team leader
Hand-on experience with authoring regulatory filings for biologics and sterile parenteral products
People management experience

Preferred

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

Benefits

Paid time off (vacation, holidays, sick)
Medical/dental/vision insurance
401(k)

Company

AbbVie is a biopharmaceutical company focused on immunology, oncology, neuroscience, virology, and aesthetics. It is a sub-organization of AbbVie.

H1B Sponsorship

AbbVie has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (273)
2024 (190)
2023 (225)
2022 (284)
2021 (186)
2020 (186)

Funding

Current Stage
Public Company
Total Funding
$15B
2024-02-27Post Ipo Debt· $15B
2023-03-08Post Ipo Equity· $0.25M
2012-12-20IPO

Leadership Team

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Robert Michael
Chairman of the Board and Chief Executive Officer
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Micah Bregman
Vice President, Global Strategy and Pipeline, Allergan Aesthetics
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Company data provided by crunchbase