Scientist II Analytical Development

Technical and GMP expert that will be responsible for supporting analytical method lifecycle activities at external AD/QC laboratories for latephase antibodydrug 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 revalidations 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 phaseappropriate qualification and requalification 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 analyticalrelated 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 incountry 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 largemolecule reference standard management
• Strong knowledge of GMP requirements ICH guidelines and compendia (USP and Ph. Eur.)
• Experience working with thirdparty 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 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 shortterm incentive programs. 

Note: No amount of pay is a 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 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.

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