Associate Scientist II, Biologics Drug Product Development
AbbVie
19 days ago
On-site
Irvine, CA
$58,656 - $110,500 USD yearly
Operations
Position Description:
- Support formulation and process development of protein biologics for clinical stage molecules, with a focus on highly potent molecules for therapeutics and aesthetic use.
- Conduct all work in compliance with AbbVie internal and applicable regulatory requirements; work requires access to select agents and highly potent compounds (Biosafety level 2 laboratories).
Responsibilities:
- Design and execute formulation composition and drug product process development studies for sterile liquids, lyophilized, and pre-filled dosage forms.
- Manufacture drug product formulation batches to evaluate formulation stability and/or support in vivo studies.
- Conduct clinical in-use studies to guide dose administration.
- Interpret results from multistage experiments; note deviations and propose relevant new experiments.
- Generate high-quality data; prepare formulation data summaries, technical reports, and scientific presentations.
- Investigate and develop novel experimental approaches/technologies in drug product development.
- Accurately document and report experiments in full compliance with GSP standards.
Qualifications:
- BS with 3–5 years, or MS with 0–2 years of industry experience in pharmaceutics/pharmaceutical sciences/chemical engineering/analytical sciences (or equivalent); no PhD considered.
- CMC development experience in protein formulation, drug delivery, or analytical functions (preferred).
- Ability to execute and troubleshoot experiments using rational/critical thinking; highly organized and detail oriented.
- Hands-on protein characterization and stability analytical experience (preferred): HPLC, CE-SDS, spectroscopy, HIAC, MFI, DLS, ELISA, Karl Fisher.
- Prior drug product manufacturing and lyophilization experience (desirable).
- Excellent communication skills (required).
Benefits (as stated):
- Paid time off; medical/dental/vision insurance; 401(k) to eligible employees.
- Eligible for short-term incentive programs.
- Support formulation and process development of protein biologics for clinical stage molecules, with a focus on highly potent molecules for therapeutics and aesthetic use.
- Conduct all work in compliance with AbbVie internal and applicable regulatory requirements; work requires access to select agents and highly potent compounds (Biosafety level 2 laboratories).
Responsibilities:
- Design and execute formulation composition and drug product process development studies for sterile liquids, lyophilized, and pre-filled dosage forms.
- Manufacture drug product formulation batches to evaluate formulation stability and/or support in vivo studies.
- Conduct clinical in-use studies to guide dose administration.
- Interpret results from multistage experiments; note deviations and propose relevant new experiments.
- Generate high-quality data; prepare formulation data summaries, technical reports, and scientific presentations.
- Investigate and develop novel experimental approaches/technologies in drug product development.
- Accurately document and report experiments in full compliance with GSP standards.
Qualifications:
- BS with 3–5 years, or MS with 0–2 years of industry experience in pharmaceutics/pharmaceutical sciences/chemical engineering/analytical sciences (or equivalent); no PhD considered.
- CMC development experience in protein formulation, drug delivery, or analytical functions (preferred).
- Ability to execute and troubleshoot experiments using rational/critical thinking; highly organized and detail oriented.
- Hands-on protein characterization and stability analytical experience (preferred): HPLC, CE-SDS, spectroscopy, HIAC, MFI, DLS, ELISA, Karl Fisher.
- Prior drug product manufacturing and lyophilization experience (desirable).
- Excellent communication skills (required).
Benefits (as stated):
- Paid time off; medical/dental/vision insurance; 401(k) to eligible employees.
- Eligible for short-term incentive programs.