AbbVie Scientist II/ Senior Scientist I in Worcester, Massachusetts
The Scientist II/ Senior Scientist I will be responsible for technical support of commercial and near-commercial antibody drug conjugate (ADC) drug substance (DS) processes. The job requires demonstrated laboratory competencies and manufacturing support competencies. The candidate must be able to independently design, conduct and interpret laboratory scale ADC experiments.
In addition to understanding antibody-drug conjugation chemistry, knowledge of relevant analytical techniques is also required. Commercial scale process support competencies include technical transfer, protein purification unit operations, regulatory compliance requirements and process validation, including CPV-compliant trending.
Responsibilities include providing on-floor manufacturing support at AbbVie and at TPMs, troubleshooting, identification and implementation of continuous improvement programs, and support for CMC regulatory filings. The candidate must be able to present complicated issues to multiple functional areas (e.g. R&D, Operations, QA, QC, Regulatory and Management) and work cooperatively to resolve them. Excellent written and verbal communication skills are essential.
Key Responsbilities Include:
Support commercial and near-commercial ADC DS manufacturing operations utilizing both laboratory and manufacturing support competencies.
Laboratory scale responsibilities: * Design efficient experimental plans to solve complicated problems * Execute, and/or supervise execution of, experiments * Interpret data accurately and independently, and present concise summaries to stakeholders * Document work appropriately in an electronic notebook * Write clear, concise and accurate reports, technical memos and presentations * Maintain and troubleshoot lab equipment and identify and implement lab optimization projects * Train, and work cooperatively with, junior scientists and contingent workers Manufacturing support responsibilities: * Ownership of all process-related aspects of assigned manufacturing projects (product quality and productivity) * Apply scientific/engineering principles and a deep practical understanding of ADC unit operations to troubleshoot and improve processes * Identify and implement of continuous improvement projects * Lead technical transfer projects * Lead process validation activities for assigned projects, including CPV-compliant trending * Data trending: gather data from the manufacturing floor, enter/verify data in data trending systems, and identify, interpret and propose response to OOT and non-conforming events and other problems * Regularly communicate manufacturing project status, including presentations to Project Team meetings and to upper management * Prepare assigned sections of annual regulatory reports and reply to process-related regulatory agency requests * Contribute to plant-wide regulatory compliance initiatives
Position will be hired based on level of experience.
Basic Required Skills:* * Laboratory and/or manufacturing scale experience with typical protein purification unit operations (centrifugation, filtration, chromatography, UF/DF) * Development of ADC and/or protein purification unit operations * Excellent written and verbal communication skills. Highly competent with Microsoft Office suite.
Preferred Skills:* * Handling highly potent / toxic compounds in a laboratory * Chromatography workstation experience (programming and running), esp. w/ AKTA / Avant * Understanding of antibody-drug conjugation chemistry, knowledge of relevant analytical techniques * Advanced statistics knowledge, including statistical process control (SPC) and design of experiments (DOE). Experience with JMP or other statistical / DOE software a plus.
Educational Requirements:* * Bachelor’s Degree with typically 7 years, Master’s Degree with typically 5 years, or a PhD with 0-1 years, in a biologics process-related field.
Job Classification: Experienced
Job: RESEARCH AND DEVELOPMENT
Primary Location: USA-Massachusetts-Worcester
Travel: Yes, 10 % of the Time
Req ID: 1706264
Equal Opportunity Employer Minorities/Women/Veterans/Disabled