Principal Research Scientist II, Parenteral PDS&T Analytical Development jobs in United States
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AbbVie · 2 days ago

Principal Research Scientist II, Parenteral PDS&T Analytical Development

AbbVie is a global biopharmaceutical company focused on innovative medicines and solutions. They are seeking a Principal Research Scientist II to lead analytical strategies for late-stage biologics parenteral products, ensuring compliance with regulatory submissions and collaborating with cross-functional teams.

BiotechnologyFinancial ServicesHealth CareMedicalPharmaceuticalVenture Capital
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Comp. & Benefits
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H1B Sponsor Likelynote

Responsibilities

Develop analytical strategies and communicate with PDS&T business partners for experimental execution in support of stability studies, comparability studies, and extended characterization of biologics products (e.g., mAbs, ADCs, bispecifics)
Interpret and identify data trends in key analytical release and stability assays
Develop robust analytical control strategies including commercial specifications
Author regulatory filings (including IND and BLA filings) and address questions from health authorities
Proactively advise and share knowledge/expert opinions with peers and senior management. Mentor peers in project management and development of analytical strategies
Collaborate with third party laboratories and manufacturers for outsourced programs to ensure CMC timelines are met
Author and/or review key regulatory documents, technical memos, and reports
Encourage ideas for continuous improvement activities and initiatives within work group

Qualification

Analytical ChemistryBiologics DevelopmentProject ManagementHPLCStatistical AnalysisScientific WritingMultitaskingVerbal Communication

Required

PhD (8+ years), Master's Degree (14+ years), or Bachelor's Degree (16+ years) in scientific discipline (e.g., Analytical Chemistry, Biochemistry, or Biology) with previous work experience (6+ years) in a pharmaceutical laboratory setting
Ability to multitask and work within timelines
Demonstrated scientific writing skills and strong verbal communication skills

Preferred

Experience in project management/leadership of analytical development activities for biologic compounds (mAbs, antibody drug conjugates, and/or fusion proteins)
Experience in analytical technologies (HPLC, UV-Vis, compendial tests, and KF). Experience in bioanalytical techniques including SEC, CEX, CE-SDS, icIEF, peptide mapping, bioassay, ELISA, subvisible particle analysis for parenteral drug products
Experienced in laboratory systems (LIMS, CDS, ELN)
Statistical knowledge and experience are preferred, e.g. capability analysis and design of experiments (DOE) methodologies
Solid understanding of protein chemistry and biochemistry, particularly as related to biologics drug development

Benefits

Paid time off (vacation, holidays, sick)
Medical/dental/vision insurance
401(k)
Short-term incentive programs
Long-term incentive programs

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