Company DescriptionAbbVie'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 X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) .Job DescriptionTechnical expert in PDS&T that will independently support business continuity of on-market AbbVie's Ophthalmic products as well launch of new product. Investigate, identify, develop and optimize new methods/ techniques to address critical project needs. Continuously seek to improve existing laboratory methods and processes. Read and adapt literature to accomplish assignments. Demonstrate mastery of broad range of experimental techniques and methods of data analysis. Responsibilities
Lead projects impacting manufacturing to achieve process efficiencies, such as, increase in process yield, quality improvements, cycle time/throughput, and cost reduction initiatives.
Gather and analyze process data using statistical process control methodology for the purpose of monitoring process performance. Develop action plan to increase process robustness, prevent product loss, and control quality impact.
Responsible for providing technical support in the resolution of manufacturing investigations and executing assigned tasks as required, such as, laboratory experiments.
Lead investigations by following a structure problem solving approach and employing sound, scientific principles when identifying root cause and developing recommendations related to product and process. Generate technical justification to support and/or document process deviations/investigations and determine impact in product quality, yield, and product registration.
Member of a cross-functional team responsible for implementation of site projects/initiatives (continuous improvement, cost reduction, capacity increase, etc.) that lead to process remediation.
Project management of smaller team sub-projects in support of larger projects. Responsibility may include project coordination, monitoring, reporting, meeting management, and team communication.
Lead the implementation of process validation for technology transfers, 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 and process documentation and assure they are in compliance with applicable procedures and regulations. Writes justification memos and scientific reports supporting quality controls and manufacturing documents.
Provide scientific and technical support during regulatory audits, agency inspections and regulatory submissions (IND, BLA, NDA, PAS, etc)
Demonstrate accountability and responsibility for EHS performance and compliance through active participation and support of Abbvie's EHS program.
Qualifications
BS or equivalent education with typically 7 or more years of experience or MS or equivalent education with typically 5 or more years of experience in Chemistry, Biology or Engineering (Chemical, Mechanical, Bio-chemical, or other relevant scientific field).
Technical knowledge in fundamentals of pharmaceutical drug product process (sterile/aseptic product manufacturing, media fill, sterilization, fill finish operations, cGMP). Experience with process development and manufacturing of ophthalmic products will be highly considered.
Experience with process validation and technology transfers.
Experience with regulatory support for IND and BLA submission.
Fundamental knowledge of Medical Device Design Control (DHF, EU MDR, CE Mark)
Strong data analysis skills and experience (Minitab, JMP, Lean Six Sigma)
Demonstrated ability to independently design, execute and interpret critical experiments to answer scientific questions.
Demonstrated ability to learn, understand and master new experimental techniques.
Ability to multitask and work within timelines (Project management).
Demonstrated scientific writing skills and strong verbal communication skills.
Additional InformationApplicable 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 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.US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:https://www.abbvie.com/join-us/reasonable-accommodations.htmlSalary: $80,500 - $153,000
