Scientist II, Biologics Drug Product Development

AbbVie•Irvine, CA

5h•$84,500 - $162,000•Onsite

About The Position

Within the Biologics CMC Development organization, the incumbent will support the development of formulations, manufacturing processes, and testing of protein biologic drug products. We support projects from early development through commercialization, with a specific focus on select agents for therapeutic and aesthetic use. A key aspect of this role will be the ability to understand, design, and establish automated laboratory systems and workflows that enable high-throughput formulation screening, analytical testing, and data generation. The Scientist II will collaborate with cross-functional partners to define automation requirements, support the setup and integration of automated platforms and instrumentation, and ensure that systems are fit for purpose, reliable, and compliant with applicable procedures and quality expectations. Key to this role is the ability to develop scientific strategies, navigate challenges, oversee the work of matrixed resources, and leverage automation to improve laboratory efficiency, data quality, reproducibility, and scalability. This position requires laboratory work in areas requiring select agent (i.e., Biosafety level 2 laboratories). The ideal candidate will have hands-on experience with analytical techniques used for protein characterization and stability testing, as well as a demonstrated ability to drive innovative science in a team setting. Experience with laboratory automation, automated sample preparation, high-throughput screening, instrument integration, or automated data workflows is highly desirable.

Requirements

BS or equivalent education with typically 7+ years of experience or MS or equivalent education with typically 5+ years of experience.
A strong technical background encompassing protein formulation principle, drug product degradation pathways, and characterization approaches, is required.
Demonstrated ability to independently design, execute and interpret critical experiments to answer scientific questions.
Demonstrated ability to learn, understand and master new experimental techniques.
Ability to multitask and work within timelines.
Demonstrated scientific writing skills and strong verbal communication skills.

Nice To Haves

Hands-on experience working with highly potent compounds within a Biosafety Level 2 (BSL-2) laboratory environment.
Candidates with hands-on experience in analytical techniques used for protein characterization and stability testing, preferred (e.g., Chromatography (Reverse phase, Size exclusion chromatography (SEC), Spectroscopy techniques (UV-absorbance, fluorescence, circular dichroism etc.), Scattering techniques (Dynamic light Scattering, X-ray scattering etc.), Particle Analysis (sub micrometer, micrometer and visible particle analysis), Calorimetry (Differential scanning calorimetry (DSC), nano-DSC), ELISA and Pull down assays.
Prior experience in the development of protein product formulations in vial and pre-fillable syringes as well as lyophilization expertise is desirable.
Prior experience with aseptic processing and drug product manufacturing process tech transfer is preferred.
Prior experience with automation, data analysis, and high-throughput approaches in protein formulation, characterization, stability testing, or manufacturing processes is preferred.

Responsibilities

Plans and executes product formulation & process development activities in support of the development of new products intended for new biologic entities and life-cycle management of marketed products with a focus on biologic drug products.
Generate high-quality data based on sound scientific principles and prepare formulation data summaries, technical reports, scientific presentations, and regulatory documents.
Participate in drug product development teams and contribute to the planning and execution of product studies including formulation and drug product process development, based on project goals and timelines.
Actively interact with CMC members and other AbbVie stakeholders to enable the successful development of AbbVie drug products.
Drive innovation by investigating and developing novel experimental approaches and/or technologies in the field of drug product development and raising visibility within the scientific community through external presentations and publications.
Develop and implement laboratory automation systems and workflows to support high-throughput formulation screening, analytical testing, data generation, and process optimization while improving efficiency, reproducibility, and data quality.