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 at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.
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.
•Bachelor’s degree or equivalent education and typically 12 years of experience, master’s degree or equivalent education and typically 10 years of experience, PhD and typically 4 years of experience.
•Possess thorough theoretical and practical understanding of own scientific discipline.
•Effective writer and communicator of research or other regulatory materials.
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 short-term incentive programs.
This job is eligible to participate in our long-term incentive programs
Note: No amount of pay is 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 Company's sole and absolute discretion unless and until paid and may be modified at the Company’s 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 AbbVie’s 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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