Job Description

Description

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 at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description Key Responsibilities Include: • Leads freeze-drying and vacuum-drying in drug product lyophilizing process manufacturing with scientific based experimental studies and computation modeling at heat and mass transfer to support from a) study designs, conduct experiments, analyze data, and model lyophilization (freeze-drying) process and evaporative processes to b) scale up of manufacturing process from lab, pilot to commercial scales of protein-based and small molecular formulations. • Leads computational fluid dynamic (CFD) and finite element analysis (FEA) with modeling responsibility to support the drug manufacturing and drug-device delivery system to develop predictive manufacturing process for commercial scale manufacturing process of electromechanical based medical devices, pharma drugs, parenterals, toxins, and combination products. • Assume tech Leadership to manage scientific tasks and projects cross-function teams and enable to complete deliverables with quality and in a timely manner. • Supports modeling development to predict freeze-dry and/or vacuum drying cycle performance under various process conditions for different drug products to enhance product quality and improve manufacturability. • Performs engineering analysis by using heat and mass transfer for the lyophilization process and vacuum-drying process with experiences in different freeze-dryers and support analytical techniques. • Analyzes the modeling outcome and provides scientific explanation and justification of results based on the generated data from modeling and analysis. • Partners with team members to ensure all objectives are met; supports team to design and develop freeze-drying process of the critical process wetting and product parameters. • Prepares study design and provides written, verbal deliverables, reports and presentations for management and stakeholder reviews during the progress and at the project final conclusion. • Assumes CFD and FEA responsibility to include compliance with required quality and regulatory to assure practice of the developed models fulfilling all essential standards internally and externally. • Participates in various scientific and technical presentations, discussion, and communication; summarize key observation to support the project team for decision making. • Responsible for compliance with applicable Corporate and policies and procedures. Ensures quality and effectiveness of key results of major projects within function through sound design, early risk assessments, and implementation of fallback strategies. Has full awareness of the potential consequences (defects and failure modes) of design changes to established processes. Mitigates risk within functions through sound design, early risk assessments and implementation of fallback strategies. • Identifies, plans, and conducts medium- to large-size projects across engineering disciplines requiring custom, risk-managed execution plans, investigations, and/or equipment. Makes difficult decisions regarding priorities between projects. Responsible for achieving the project's financial targets in support of business objectives and life cycle costs. Qualifications • A Ph.D. degree in 2-5 years of working experiences and training in engineering of mechanical, chemical, materials science, aerospace, pharmaceutical with lyophilization (freeze-drying) and vacuum drying experience and academic training is preferred. A M.S. in Engineering, science, or closely related discipline is acceptable, or equivalent technical experience plus demonstrated CFD and/or FEA competence, with a desired 10+ years of significant engineering and/or operational experience. • Experiences in freeze-dry and vacuum-drying in drug product lyophilizing manufacturing process with scientific based experimental studies and computation modeling at heat and mass transfer to support from a) study designs, conduct experiments, analyze data, and model lyophilization (freeze-drying) process and evaporative processes to b) scale up of manufacturing process from lab, pilot to commercial scales of protein-based and small molecular formulations. • Experiences in computational fluid dynamic (CFD) and finite element analysis (FEA) with modeling responsibility to support the drug manufacturing and drug-device delivery system to develop predictive manufacturing process for commercial scale manufacturing process of electromechanical based medical devices, pharma drugs, parenterals, toxins, and combination products. • Experiences in tech Leadership to manage scientific tasks and projects cross-function teams and enable to complete deliverables with quality and timely manner. • Experience and knowledge of computational fluid dynamic (CFD) analysis in heat transfer (conduction, convection, and radiation), mass transfer and momentum transfer for scientific problem solving and its associated materials knowledge of the subjects of applications. • Experience and knowledge of finite element analysis (FEA) in mechanical design, manufacturing process and reliability analysis in medical devices and device-drug delivery systems from mechanical device systems to complex electromechanical device systems for drug delivery. • Experience and knowledge in freeze-dry modeling and/or vacuum-drying modeling to support with lyophilization process and/or evaporative processes, and scale up of manufacturing process from lab, pilot to commercial scales of protein-based and small molecular formulations. • Experience in tech Leadership to manage scientific subjects cross-function teams and enable to complete deliverables with quality and timely • Training at graduate / postgraduate degree in mechanical engineering, chemical engineering, aeronautics and astronautics engineering, mathematical engineering, biomedical engineering, pharmaceutical sciences, physical chemistry, or other relevant degree with practices in FEA and CFD. • Experiences in employing CFD and/or FEA engineering and tools to develop and apply modeling and simulation to determine mixing, fermentation/seeding, compounding, and filling process in drug substance (DS) and drug product (DP) fluid dynamics and device design, manufacturing, and reliability analyses in solid mechanicals in device for drug-device delivery to patients for different therapies. • Experiences in drug product freeze-drying, vacuum drying and lyophilization drug reconstitution, and their related modeling process to support the commercialization processes from lab, pilot to commercial scale manufacturing. • Has demonstrated excellence in breadth and depth within CFD and/or FEA discipline and across disciplines and advanced publication in lyophilization (freeze-drying) and vacuum drying fields and experiences with academic training. • Has a career history marked by a consistent series of CFD and/or CFD technical contributions and accomplishments in freeze-drying and vacuum drying fields. Significant contribution to pharma drug product or process development or improvement through creative application of technical effort will equally be recognized. • Possesses a strong technical knowledge and application of concepts, practices, and procedures. Works on problems of complex scope where analysis of situations or data involves multiple competing factors. Exercises judgment and advises management as to the appropriate actions. • Interacts well with diverse groups within engineering and maintains strong working relationships with internal and external collaborators. • Listens to and understands others' points of view and articulates tactfully and respectfully one's own perspective orally, in writing, and in presentations. • Works well with other engineers and/or scientists in a collaborative, fast-paced, team matrix, and goal-driven environments. • Possesses interpersonal skills to negotiate and reconcile differences. • Has a technical background in health care, medical devices, pharmaceutical, biologics, or similar industries (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 short-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 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.