Scientist II, Biologics Analytical Development (Fully Onsite)

AbbVie; Irvine (CA); Sur place; USD 120 000 - 180 000; Plein temps

Résumé du poste

AbbVie Inc. is seeking an experienced Scientist to develop and validate analytical methods for biologics.

The role focuses on early development of complex bioassays to understand kinetics and mechanisms of action, working independently to plan experiments and generate data for regulatory filings. The candidate will support formulation, stability studies, and technical report writing, maintaining compliance with biosafety and company requirements.

Qualifications

• BS or MS with related field and several years of hands-on experience in biologics assay development.
• Experience in developing, validating and transferring analytical methods for biologics under regulated environments.
• Strong understanding of quality systems and regulatory expectations in biotech development.

Responsabilités

• Develop and validate analytical methods for biopharmaceuticals, including ELISA, qELISA and other bioassays.
• Develop and optimize bioassays and functional assays to assess biological activity and product attributes.
• Prepare technical reports, SOPs and transfer methods to other sites or teams as needed.
• Collaborate with cross-functional teams to design experiments and interpret data for regulatory filings.

Connaissances

Bioassay development

ELISA

TR-FRET

AlphaLISA

Bioanalytical methods

Regulatory compliance

Cross-functional collaboration

Formation

Bachelor's degree in bioscience

Master's degree in bioscience

Outils

qELISA

Enzyme activity assays

Description du poste

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

Our department develops analytical methods for the analysis and characterization of biologics in CMC development. We are looking for an experienced and accomplished Scientist with a track record of developing bioassays and functional assays. In particular, the scientist will work on early development of complex bioassays to improve our understanding of the kinetics and mechanisms of action.

The individual will primarily work independently to plan experimental work and carry out multiple analytical methods to support AbbVie biologics projects depending on departmental needs. Maintains a productive and collaborative laboratory environment consistent with regulatory and company expectations.

The individual may also support as a secondary priority biologics process development, formulation development, and stability studies. This includes independently generating, compiling, and evaluating data for technical reports to support regulatory filings for new and currently marketed biological products. The individual may also support writing sections or subsections of technical reports, method and/or operational SOPs. The individual independently carries out multiple analytical methods to support AbbVie biologics projects depending on departmental needs. Maintains a productive and collaborative laboratory environment consistent with regulatory and company expectations.

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.

Responsibilities

• Support development of phase appropriate methods to support biologicsdevelopment programs.
• Execute the development and validation of analytical methods for the analysis and characterization of biopharmaceuticals. Create written procedures and protocols. Transfer, qualify or validate methods as needed.
• Apply routine and specialized analytical techniques to characterize and quantify biopharmaceuticals, including assay development for protein mass determination.
• Develop and optimize bioassays and functional assays, including ELISA, TR-FRET, AlphaLISA, and related assay platforms.
• Support the development of assays that assess biological activity, potency, mechanism of action, and relevant product attributes.
• Actively participate on cross-functional teams within Biologics Development and provide support to external departments. Openly share scientific expertise and collaboratively help the team to formulate rational solutions to problems.
• Develop protocols and SOPs, train staff and maintain the laboratory consistent with departmental and company requirements. Understand, document, and adjust Quality Systems to match the project stage (e.g. pre-development or development).
• Maintain a good and current knowledge of scientific and technical literature pertinent to the project and necessary for development of state-of-the-art analytical methods, including the acquisition of necessary equipment.

Qualifications

• BS or equivalent education with typically 7+years of experience or MS or equivalent education with typically 5+ or more years of experience, is required.
• Advanced knowledge and experience in developing, validating and transferring methods for biologics, including qELISA (quantitative), Potency Assays, enzyme activity assays and other bioassays.
• A solid understanding of methods and procedures related to the production and characterization of biopharmaceuticals in a regulated environment is expected.
• Understanding in CMC development strategy of biologics drugs is expected.
• Familiarity with cell-based assays, molecular biology techniques, or protein characterization methods.
• Understanding of analytical method development, qualification, validation, and transfer principles.
• Ability to analyze, interpret, document, and communicate experimental data effectively.
• Ability to work collaboratively in a cross-functional team environment and manage multiple activities with appropriate guidance.

Additional Information

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

• The compensation range described below is the range of possible base pay compensation that the Companybelieves ingood faith it will pay for this role at thetimeofthis posting based on the job grade for this position.Individualcompensation paid within this range will depend on many factors including geographiclocation,andwemayultimatelypaymore or less than the posted range. This range may bemodifiedin thefuture.
• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick),medical/dental/visioninsurance and 401(k) to eligibleemployees.
• This job is eligible toparticipatein our short-term incentiveprograms.

Note: No amount of payis considered to bewages or compensation until such amount is earned, vested, anddeterminable.Theamountandavailabilityof anybonus,commission, incentive, benefits, or any other form ofcompensation and benefitsthat are allocable to a particular employeeremainsin the Company'ssoleandabsolutediscretion unless and until paid andmay bemodifiedat the Company’s sole and absolute discretion, consistent withapplicable 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,

US & Puerto Rico applicants seeking a reasonable accommodation,