at AbbVie in North Chicago, Illinois, United States
Job 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
Technical expert with hand-on experiences with process validation, process technology transfers, sterile product support, aseptic process development and design control.
Experience with Sterile GMP, Project Management, IND and BLA submission, Six Sigma and in development and manufacturing of ophthalmic products will be highly considered.
Responsibilities:
+ Independently investigate, identify, develop and optimize new methods/process/techniques to address critical project needs.
+ Play a critical role as cross functional team member to achieve process efficiencies such as increase process yield, quality improvements, cycle time/throughput, and cost reduction initiatives.
+ Gather and analyze process data using statistical process control methodology. Develop action plan to increase process robustness, prevent product loss, and control quality impact. Participate in process performance monitoring such as Track & Trend.
+ Responsible for providing technical support in the resolution of shop floor situations and executing assigned tasks as required by the operational area.
+ Generate technical justification to support and/or document process deviations/investigations and determine impact in product quality, yield, and product registration.
+ Play a critical role as cross functional team member to implement operational changes, new raw materials, and introduction of new process/technology. Generate technical justification determining impact of change and protocols/reports/manufacturing documents that support its execution. Assist the execution of experimental, demonstration, and validation lots.
+ Maintain up-to-date product process documentation and assure they are in compliance with applicable procedures and regulations. Writes justification memos and scientific reports of quality controls and manufacturing documents.
+ Demonstrate accountability and responsibility for EHS performance and compliance through active participation and support of AbbVie’s EHS program.
+ Independently design, execute and interpret critical experiments to answer scientific questions. Understand the broad objectives of the project as well as their role in achieving those objectives, and modify experimental plan when required, to respond.
+ Effectively organize and present scientific plans and data.
+ Contribute to writing and conceptual framework of publications, presentations, and patents.
+ Routinely read and apply relevant scientific literature. Impact projects mostly through lab and/or pilot-plant based activities where applicable.
Qualifications
+ Bachelor’s Degree or Master’s Degree in Chemical, Biochemical or Engineering with typically 7 years or 5 years of experience, respectively, in Pharma Process, Manufacturing and Process Engineering.
+ Technical knowledge in fundamentals of pharmaceutical process.
+ Demonstrated ability to independently design, execute and interpret critical experiments to answer scientific questions.
+ Ability to multitask and work within timelines.
+ Demonstrated scientific writing skills and strong verbal communication skills.
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.