AbbVie · 15 hours ago
Associate Director, tLNP Formulation
North Chicago, IL
Full-time
Onsite
Senior Level, Lead/Staff
8+ years expAbbVie is a company dedicated to discovering and delivering innovative medicines and solutions that address serious health issues. They are seeking a leader to oversee formulation development and manufacturing processes for targeted lipid nanoparticles (tLNPs), ensuring compliance with GMP standards while managing cross-functional teams and external partners.
BiotechnologyFinancial ServicesHealth CareMedicalPharmaceuticalVenture Capital
Responsibilities
Responsible for overseeing formulation development of targeted lipid nanoparticles (tLNPs) entering FIH, as well as formulation optimization and commercial formulation definition prior to pivotal clinical trials
Responsible for evaluation of novel product presentations for tLNPs, which may include a lyophile, spray dried powder, nonaqueous suspension, or other advanced presentations, and the process development thereof
Designs, oversees, and reviews clinical in-use studies to evaluate the stability and compatibility of tLNP drug products
Manages contract development and manufacturing organizations (CDMOs) involved in sterile fill finish operations of tLNPs
Reviews and approves documents related to formulation development and drug product production, including technical transfer, process development reports, qualifications, master and executed batch records, and campaign summary report
Works closely with others in CMC and quality assurance to lead investigations and data analysis to address deviations/non-conformance and implement change controls to ensure timely/prompt release of batches
Authors and reviews drug product sections for regulatory submissions
Contributes to the development and monitoring of departmental goals and budgets
Qualification
Required
PhD. in Chemistry, Molecular Biology, Chemical or Bioengineering and 8+ years of related experience, or MS/BS with 14/16+ years of related experience
Extensive experience working with protein therapeutics, antibodies, conjugation chemistries, and genetic medicines including LNPs
Experience with process development, analytical characterization, process scale-up, and/ or regulatory descriptions of drug product manufacturing processes/registration
Experience with project management with external partners
Experience with GxP/ GMP production
Preferred
Familiarity with quality by design, late-stage PD and process characterization
Benefits
Paid time off (vacation, holidays, sick)
Medical/dental/vision insurance
401(k)
Company
AbbVie
AbbVie is a biopharmaceutical company focused on immunology, oncology, neuroscience, virology, and aesthetics. It is a sub-organization of AbbVie.
10001+ employees
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 CompanyTotal Funding
$15B2024-02-27Post Ipo Debt· $15B
2023-03-08Post Ipo Equity· $0.25M
2012-12-20IPO
Leadership Team
Robert Michael
Chairman of the Board and Chief Executive Officer
Micah Bregman
Vice President, Global Strategy and Pipeline, Allergan Aesthetics
Recent News
2026-01-23
2026-01-20
2026-01-20
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