Principal Research Scientist II, Biologics Drug Substance Process Development

The CMC Biologics Development group at AbbVie's Irvine, CA location seeks an accomplished senior lead scientist for the neurotoxin biologics drug substance development team. The Principal Research Scientist II will lead to support the discovery and pre-development and early-stage development of neurotoxins and other therapeutics programs (including peptides). She/He will be responsible for leading and working with the diverse team of research scientists and design & screen expression vectors, protein expression and generating high quality protein at a research scale to support discovery projects.  

The ideal candidate will have in-depth knowledge and experience in biologics process development and protein characterization including hands-on skills in fermentation and purification development. The primary function of this position is to lead, design, and execute the experiments at small scale working with diverse team members. This position also requires a desire and ability to work as an integral part of a team and supporting sample/data analysis, tech transfer activities, authoring/supporting regulatory documents including INDs and/or BLAs. The candidate will demonstrate a high degree of flexibility, creativity, innovations and initiatives applied to the various duties and aspects of position. 

The candidate will be able to lead by influence and maintain a productive, collaborative, and inclusive laboratory environment in compliance with regulatory and company expectations. Experience managing projects from early-stage discovery research through the transition to development stage is highly desired. 

Key responsibilities:

Develop key strategies to execute early-stage process development activities for drug substance developability assessment with “begin with the end in mind” mindset.

Drive effective expression vectors and host cell screening process, data analysis, process monitoring, process learning and continuous improvements.

Drive functional performance by leading team members designing, producing, and purifying novel protein therapeutics.

Develop and execute a strategy in alignment with functional goals and key scientific objectives of multidiscipline teams.

Advance scientific expertise within the function and collaborate with cross-disciplinary teams to advance programs from research to development.

Utilize process trends and laboratory derived data to support technical investigations and aide in process optimization/development to reduce the CMC risks.

Author and/or review technical reports, process summaries, protocols, and quantitative analyses.

Leads analysis, and interpretation of CMC-related technical data to author CMC dossier for clinical trial applications (e.g., INDs/IMPD) and BLA/MAA and other documents needed to support regulatory interactions and filings for CMC for biologics.

Constantly evaluate and assess the advanced technology and tools in up-stream/down-stream and implement that increase throughput, quality, and consistency of proteins and experiments.

Understand the impact and mitigate the risk of upstream & downstream processes during the tech transfer to manufacturing facility.

Develop protocols and SOPs, train staff as necessary and adjust development activities to match the project stage (e.g., pre-development to phase appropriate).

Actively participate in cross-functional teams within Biologics CMC Development and provide support to external departments. Openly share scientific expertise and collaboratively help the team to formulate rational solutions to problems.

Perform fundamental literature and patent searches related to processes under development.

Supports build talent/expertise for team members by involving them and ensuring the use of appropriate process development tools.

Ensure compliance with Federal Regulations for key documentation and sample inventory.

Qualifications

• PhD in Biology, Biochemistry, Microbiology, Chemical Engineering, Bioengineering or equivalent field with 8+ years of pharma or biotech industry experience; Master’s degree in Science with 14 years of related work; Bachelor’s degree in Science with 16 years related work is required.
• Extensive experience in biologics process development and direct experience in design and development of high throughput approaches for protein production and screening and process analytics.
• Experience in developing novel manufacturing technologies is highly desirable.
• Experience in authoring CMC dossier for clinical trial applications (e.g., INDs/IMPD) and/or BLA/MAA is required.
• Highly collaborative, team-oriented, and considerate of the needs of others.
• Strong interpersonal skills and ability to collaborate with diverse groups within the organization and external partners.
• Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
• Ability to work independently and collaboratively in a matrixed team environment consisting of internal and external team members.
• This position requires the individual to work with and in areas requiring select agents access (biosafety level 2 and 3 laboratories).

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: 

The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future. We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees. This job is eligible to participate in our short-term incentive programs.  This job is eligible to participate in our long-term incentive programs. 

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law. 

#LI-Onsite

AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community, and embracing diversity and inclusion. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.