Allergan Aesthetics, an AbbVie Company · 1 month ago
Principal Research Scientist I PDS&T
North Chicago, IL
Full-time
Onsite
Senior Level, Lead/Staff
$121K/yr - $230K/yr
6+ years expAbbVie is a global biopharmaceutical company focused on innovative medicines and solutions. They are seeking a Principal Research Scientist I to lead CMC drug product projects, specifically for parenteral drug product process development and commercial site scale-up. The role involves designing lab studies, conducting experiments, and collaborating across functions to ensure successful product development.
BeautyManufacturingPharmaceuticalWellness
Responsibilities
Independently design and conduct critical experiments that further project goals. Implement and may innovate new experimental protocols/techniques for parenteral DP characterization studies to enable process scale up
Interpret results and draw conclusions from own multistage experiments, note significant deviations, then suggest, design, and pursue relevant experiments
Tech transfer activities for parenteral DP from development scale up to clinical/commercial scale
Support drug product manufacture at GMP facilities from clinical to PPQ and commercial batches
Understand relevant scientific literature and apply theoretical framework to solving problems within scientific discipline in a timely manner
Authoring of comprehensive, scientifically sound reports, e.g. development reports or risk assessments that serve as source documents for regulatory submissions. Author portions of regulatory submissions to designated health authorities related to these reports
Develop and maintain comprehensive project plans, timelines and development and/or scale up tech transfer strategy; technical projects at all stages of development are included, from phase II clinical through commercial
Lead cross-functional PDS&T product teams and represent the CMC team and/or PDS&T in interface with PDS&T leadership, other Operations functions, other AbbVie functions and external partners. Participate in or coordinate Governance efforts such as Product Performance Teams or gate reviews
Prepare and review submissions through registration of the product as well as post-approval life-cycle management. Serve as a peer reviewer for submissions and understand how regulatory submissions limit operational changes
Establish and foster partnerships with key customers and counterpart functions to facilitate effective collaboration. Identify and promote best practices among PDS&T CMC leads
Understand and adhere to corporate standards regarding code of conduct, safety, appropriate handling of materials, controlled drug and radioactive compounds, GxP compliance, and animal care where applicable
Qualification
Required
BS or equivalent education and extensive, typically 14+ years of experience; MS or equivalent education with typically 12+ years of experience; PhD with typically 6+ years of experience in area or scientific area of discipline
Demonstrated ability to function as a principle investigator, generating original technical ideas and research or development strategies
Demonstrate creative 'out of the box' thinking to solve difficult technical problems and champion new technologies to achieve project goals
Recognized and sought out as an expert in his/her discipline within the company and possibly externally
Experienced and demonstrated success as primary author of publications, presentations, regulatory documents and/or primary inventor of patents
Demonstrated scientific communication and presentation skills by presenting at leading scientific conferences
Independently design and conduct critical experiments that further project goals. Implement and may innovate new experimental protocols/techniques for parenteral DP characterization studies to enable process scale up
Interpret results and draw conclusions from own multistage experiments, note significant deviations, then suggest, design, and pursue relevant experiments
Tech transfer activities for parenteral DP from development scale up to clinical/commercial scale
Support drug product manufacture at GMP facilities from clinical to PPQ and commercial batches
Understand relevant scientific literature and apply theoretical framework to solving problems within scientific discipline in a timely manner
Authoring of comprehensive, scientifically sound reports, e.g. development reports or risk assessments that serve as source documents for regulatory submissions. Author portions of regulatory submissions to designated health authorities related to these reports
Develop and maintain comprehensive project plans, timelines and development and/or scale up tech transfer strategy; technical projects at all stages of development are included, from phase II clinical through commercial
Lead cross-functional PDS&T product teams and represent the CMC team and/or PDS&T in interface with PDS&T leadership, other Operations functions, other AbbVie functions and external partners. Participate in or coordinate Governance efforts such as Product Performance Teams or gate reviews
Prepare and review submissions through registration of the product as well as post-approval life-cycle management. Serve as a peer reviewer for submissions and understand how regulatory submissions limit operational changes
Establish and foster partnerships with key customers and counterpart functions to facilitate effective collaboration. Identify and promote best practices among PDS&T CMC leads
Understand and adhere to corporate standards regarding code of conduct, safety, appropriate handling of materials, controlled drug and radioactive compounds, GxP compliance, and animal care where applicable
Preferred
Strong laboratory skills and experience focused on manufacturing process development for monoclonal antibodies, antibody constructs/conjugates or other parenteral formulations
Knowledge and experience with manufacturing controls for container closure systems, including vials, prefilled syringes, and prefilled cartridges
Scientific problem solving, experimental design, and trouble shooting skills
Solid understanding of the various unit operations of aseptic manufacturing for liquid and lyophilized products such as bulk freeze thaw, compounding/mixing, filtration, filling and lyophilization
Experience in laboratory documentation systems, including ELN, and demonstrated experience with technical report writing
Technical understanding and experience with small molecule products manufacturing, development, quality and analytics is required
Knowledge and experience with FDA and global regulatory requirements for CMC issues is required
Ability to influence internal and external experts on CMC regulatory issues, independently
Demonstrated excellence in writing, presentation, and overall communication
Benefits
Paid time off (vacation, holidays, sick)
Medical/dental/vision insurance
401(k)
Short-term incentive programs
Long-term incentive programs
Company
Allergan Aesthetics, an AbbVie Company
At Allergan Aesthetics, an AbbVie company, we develop, manufacture, and market a portfolio of leading aesthetics brands and products.
1001-5000 employees
H1B Sponsorship
Allergan Aesthetics, an AbbVie Company 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
2024 (1)
2023 (1)
2022 (16)
2021 (14)
2020 (5)
Funding
Current Stage
Late StageLeadership Team
Nicole Mowad-Nassar
Senior Vice President, AbbVie and President, Global Allergan Aesthetics
Recent News
2025-12-04
Company data provided by crunchbase