Scientist II, Analytical Development

Company Description

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 immunology, oncology, neuroscience, and eye care and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us atwww.abbvie.com. Follow @abbvie onTwitter,Facebook,Instagram,YouTubeandLinkedIn.

Job Description

Technical and GMP expert that will be responsible for supporting analytical method lifecycle activities at external AD/QC laboratories for late-phase antibody-drug conjugate (ADC) development. The candidate will support CMC activities to enable filing and commercialization of ADC programs. The candidate will manage antibody and ADC reference standard programs for all development phases.

Responsibilities:

• Support validations, re-validations, transfers, continued performance verification (trending), optimization, troubleshooting, etc. for antibody and ADC methods established at external laboratories for IPC, release, and stability testing
• Set strategy and oversee execution of phase-appropriate qualification and re-qualification of antibody and ADC reference standards (RS), track and manage RS inventory at external laboratories, determine forecasts and work with external organizations to fill and qualify new RS when needed
• Author or review all documentation (protocols, reports, test methods) related to the activities above; collaborate closely with QA to ensure applicable requirements are met (GMP, ICH, compendial, etc.)
• Plan and execute laboratory experiments to support method optimization or troubleshooting
• Author change controls for analytical-related changes and support deviation/excursion management
• Serve as analytical representative on CMC team; work closely with manufacturing sciences, quality assurance, regulatory CMC, and supply chain to support program objectives
• Perform statistical analysis of batch data to support specification setting and product comparability studies
• Support Regulatory CMC activities (filings, information requests, in-country registration testing)

Qualifications

• BS, MS, or equivalent education in chemistry, biochemistry, or related discipline
• At least 7 (BS) or 5 (MS) years experience in analytical development or quality control, mostly supporting antibody or ADC therapeutics under GMP
• Experience with analytical separation methods (HPLC, CE, etc.)
• Experience with analytical method lifecycle management (validations, transfers, CPV, etc.)
• Experience with large-molecule reference standard management
• Strong knowledge of GMP requirements, ICH guidelines, and compendia (USP and Ph. Eur.)
• Experience working with third-party laboratories preferred

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 ingood faith it will pay for this role at the time of this posting based on the job grade for this position. Individualcompensation paid within this range will depend on many factors including geographic location, and we may ultimatelypay 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/visioninsurance and 401(k) to eligible employees.

• This job is eligible to participate in our short-term incentive programs.

Note: No amount of payis a considered to bewages 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 benefitsthat are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid andmay 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, serving our community and embracing diversity and inclusion. It is AbbVies 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.

US & Puerto Rico only - to learn more, visithttps://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html

Location: Waltham, MA, US

Posted Date: 10/31/2024