Scientist l Biologics Analytical RD

AbbVie; Irvine (CA); On-site; USD 90,000 - 140,000; Full time

Benefits offered by this job

Medical/dental/vision insurance

401(k) plan

Paid time off

Job summary

AbbVie Biologics Analytical Research & Development in Irvine seeks candidates for BLA-like analytical roles focusing on GMP-compliant methods for biologics. You will join a team performing separation and compendial testing (HPLC, CE, icIEF) in a cGMP environment and contribute to method development and data integrity.

Responsibilities include reviewing SOPs, collaborating with cross-functional teams, and maintaining rigorous documentation while upholding safety and regulatory standards.

Qualifications

• Bachelor’s or Master’s degree in a relevant field.
• Experience in a GxP-regulated environment is preferred.
• Strong understanding of GMP/GxP principles and regulatory expectations.
• Experience with separation methods for biologics (HPLC, CE, CE-based methods) in a cGMP environment.

Responsibilities

• Adhere to GMP, USP/EP/JP guidelines and ensure quality analytical data.
• Review methods, protocols and SOPs for GMP compliance.
• Collaborate with cross-functional teams to provide scientific expertise and solutions.
• Maintain reagents and notebooks, summarize results, and report observations clearly.
• Ensure laboratory activities comply with safety, quality, and regulatory requirements.

Skills

GMP compliance

HPLC

Capillary electrophoresis

Data integrity

Scientific communication

GxP knowledge

Education

Bachelor's or Master’s degree in a relevant field

Advanced degree (MS/PhD) in a relevant field

Tools

HPLC (RP/SEC/AEX/CEX)

Capillary electrophoresis

icIEF

GxP software/tools

Job description

Company Description

About AbbVie

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

Job Description

AbbVie Biologics Analytical Research & Development (Biologics Analytical R&D) at Irvine is an analytical sciences organization responsible for early-stage CMC analytical activities related to the development of AbbVie's biologics products. Careers in AbbVie Biologics Analytical R&D provide opportunities to work collaboratively with cross-functional teams to drive scientific understanding and innovative product development strategies. The biologics characterization group develops analytical techniques for in-depth characterization of biologics using separation and compendial techniques. We are looking for candidates with strong scientific experience to join the AbbVie Analytical R&D team and can offer exciting career opportunities for these candidates.

Responsibilities

The position requires the individual to work with and in areas requiring select agents access (i.e. Biosafety level 2 laboratories). Access to and use of select agents is regulated by federal policies. Therefore, the candidate must conduct all work activities in compliance with AbbVie internal and applicable regulatory requirements. AbbVie internal requirements include compliance with ethics, environmental health and safety, financial, human resources, and general business policies, requirements and objectives.

• Strong understanding, knowledge and ability to adhere to and apply Good Manufacturing Practices (GMP), guidelines and regulations ensuring products are consistently analyzed according to quality standards required in a GMP environment.
• Possess a strong understanding of compendial methodology (USP/EP/JP).
• Perform separation and compendial testing of raw materials, drug substances, and drug products using techniques such as HPLC, Capillary Electrophoresis, Particulate Matter, Osmolality, Karl Fischer, pH.
• Review methods, protocols and SOPs for adherence to GMP principals.
• Participate in cross-functional teams within Biologics Development and provide support and feedback to external departments. Openly share scientific expertise and collaboratively help the team to formulate rational solutions to problems.
• Maintain reagent supplies, notebooks, summarize results in written reports and communicate observations to ensure that the end user receives quality methods in a timely manner. Comply with Quality Principals related to data generation and reporting.
• Ensure laboratory activities comply with applicable AbbVie safety, quality, data integrity, and regulatory requirements.

Qualifications

• Associate Scientist II: Bachelor Degree with typically 3+ years of experience or Master degree with up to 2 years of experience working in a GxP-regulated environment.
• Scientist I: Bachelor’s Degree or equivalent education with typically 5+ years of experience, or Master’s Degree or equivalent education with typically 2+ years of experience working in a GxP-regulated environment.
• Understanding in CMC development strategy of biologics drugs is expected.
• Experience and working knowledge in executing separation methods for biologics, including HPLC (RP, SEC, AEX, CEX), gel and capillary electrophoresis (CE, icIEF), as well as compendial techniques, in a cGMP environment.
• General understanding in CMC development strategy of biologics drugs is expected.
• Strong communication and presentation skills, with the ability to clearly communicate technical data, conclusions, and recommendations to diverse technical teams.
• Strong organizational skills with the ability to manage multiple priorities.
• Working knowledge of data integrity, laboratory safety, and compliance expectations associated with GxP-regulated analytical testing.

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 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.

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 https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html