Job Description

Conceive and execute novel scientific research or development that achieves projects and area goals. Generate new scientific proposals and lead those efforts. Apply scientific, engineering principles and statistical process design/analysis to develop robust antibody/ADC manufacturing processes. Investigate, identify, develop, and optimize new methods and techniques. Act as a lead scientist in his/her area of expertise and critically evaluate relevant scientific and regulatory advances and integrate this knowledge into research or development programs. Support manufacturing, process validation, regulatory submission, and continuous improvement for late-stage and commercial manufacturing of Antibody-Drug Conjugates (ADCs) products. The candidate must have in-depth knowledge and experience including but not limited to late-phase process transfer, process validation, process improvements, etc. Excellent communication skills and the ability to work within a multi-disciplinary and cross-functional teamwork environment are essential.   

Responsibilities:

•Demonstrate the ability to resolve key project hurdles and assumptions by effectively utilizing available information and technical expertise.

Support late stage and commercial biologics manufacturing, technology transfer, process validation, investigations, troubleshooting, scale-up, and continuous improvement.

•Proactively seek out new information in the literature and incorporate this into individual project(s) as well as the overall program.

•Support/ lead new product introduction into the manufacturing area at internal AbbVie sites or at third-party manufacturers, ensuring successful tech transfer, scale up and validation for the product.

•Seize opportunities to pursue project relevant leads that are in line with the group’s strategy.

• Support CMC life cycle management and post-approval continued process validation for commercial antibody and antibody drug conjugate processes.

•Collaborate with process development for late-stage technology transfers, scale-up activities, and process validation during the transition to commercial manufacturing.

•Support product investigations and non-conformances. Identify root causes and make scientific recommendations as to the acceptability and quality of affected product lots.

•Author and review relevant CMC sections of submissions and support agency inspections, inquiries and audits.

•Represent the MSAT antibody/ADC group in CMC program teams. Interacts effectively with diverse groups within function and maintains strong working relationships with internal, global, and external collaborators.

•Understand and adhere to corporate standards regarding code of conduct, safety, appropriate handling of materials, controlled drug and radioactive compounds, GxP compliance, and animal care where applicable.

•May mentor/supervise a team of one or more and guide and evaluate the performance of those individuals; is accountable for the effective performance of the team/individuals.