Associate, Scientist II, Analytical Development (Biologics)

AbbVie Biologics Analytical Research & Development (Biologics ARD) is a global analytical sciences organization responsible for all CMC analytical activities related to the development of AbbVies therapeutic biologic products. Our scope includes AbbVies diverse pipeline of innovative therapeutic biologics medicines including monoclonal antibodies antibody drug conjugates (ADC) and other novel modalities and spans from the selection of Discovery candidate molecules through the transition of analytical methods and testing to commercial labs to support product launch. We are building a world-class team of scientists and leaders who will drive the advancement of industry-leading analytical capabilities and make meaningful contributions to advance AbbVies pipeline of innovative medicines. Careers in AbbVie Biologics ARD provide unique opportunities to work with global and cross-functional teams to drive exceptional science and innovative product development strategies.

The Analytical Development-Early Stage group within Biologics ARD is responsible for support of programs that are preparing for FIH clinical studies. The team leads Stage 1 method development optimization and collaboration with cross-functional partners the team supports early phase formulation and process development studies. Key deliverables include product control strategies informed by analytical data and method understanding; robust analytical methods suitable for commercial QC labs; comprehensive data packages that drive product and process understanding; clinical supplies release testing and stability studies to establish clinical product dating; substantial clinical trial application submission content.

Major Responsibilities

Analytical characterization and assessment of process/formulation development samples and clinical trial supplies (e.g. GMP compliant stability and release testing)

Provide process development support with fast turnaround to enable clinical material manufacturing. May require occasional off-hours support.

Design and execute experiments for method development and validation studies with supervision.

Documents experimental data appropriately in laboratory documentation system and technical memos; contributes to writing technical reports.

Maintains laboratory equipment and optimize laboratory operations for efficient use of time and resources.

Troubleshoots equipment and experimental problems.

Assists in continuous improvement activities.

Responsible for compliance with all applicable AbbVie policies and procedures.

Understand and adhere to corporate standards regarding code of conduct safety and GXP compliance.

Qualifications :

BS (2 years) or MS (0-2 years) in scientific discipline (e.g. Chemistry Biochemistry or Biology) with previous laboratory experience.

Experience in analytical methodology such as chromatography KF UV and compendial methods. Experience in bioanalytical techniques preferred (IEX HIC SEC CGE icIEF particle imaging ELISA).Experienced in laboratory systems (LIMS CDS ELN) preferred.

Experience in Microsoft Office (Excel Power Point and Word) required.

Key AbbVie Competencies:

Builds strong relationships with peers and cross functionally with partners outside of teams to enable higher performance.

Learns fast grasps the essence and can change course quickly where indicated.

Raises the bar and is never satisfied with the status quo.

Creates a learning environment open to suggestions and experimentation for improvement.

Embraces the ideas of others nurtures innovation and manages innovation to reality.

Additional Information :

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. 

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 Companys sole and absolute discretion unless and until paid and may be modified at the Companys sole and absolute discretion consistent with applicable law. 

AbbVie is an equal opportunity employer and is committed to operating with integrity driving innovation transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. 

US & Puerto Rico only - to learn more visit  & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:

Work :

No

Employment Type :

Full-time