Senior Scientist I - Bio CMC Purification Process DevelopmentFull-timeSalary Min: 96500Salary Max: 183500Workday Global Grade: 17Compensation: USD96500- USD183500- yearlyCompany DescriptionAbout AbbVieAbbVie'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 including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us atwww.abbvie.com. Follow @abbvie onLinkedIn,Facebook,Instagram,XandYouTube.Job DescriptionTheBiologics CMC Development teamat AbbVie in the Bay Area has a long and rich history of biologics development. Located in a state-of-the-art facility in South San Francisco, the team leverages its comprehensive end-to-end CMC capabilities to work collaboratively through all phases of CMC development with a primary focus on advancing complex biologic therapies, such as multi-specifics, and novel modalities, to human clinical studies and eventual licensure. This role is within a team of highly experienced scientists and managers who have directly enabled the development/IND submissions of 20+ novel biologics and successfully filed two BLAs.As a member of the CMC Purification Development group, you will apply strong downstream process-development expertise to design robust, phase-appropriate drug substance purification processes for GMP production, clinical studies, and eventual licensure. You will own purification deliverables for assigned programs, help define drug substance development strategy as a functional lead on cross-functional CMC teams, and communicate data-driven recommendations, risks, and tradeoffs to key stakeholders.This position is an onsite role in a lab-based function. To be successful candidates must enjoy and thrive in a fast-paced and highly collaborative lab environment with daily face-to-face cross-functional interactions between scientists.ResponsibilitiesDevelop, optimize, characterize, and scale up purification processes for monoclonal antibodies, multispecifics, antibody-like molecules, and other complex biologic candidates across early- and late-stage drug substance process developmentLead technology transfer to internal or external GMP manufacturing sites; author transfer packages, support facility fit and readiness, and provide technical troubleshooting during clinical manufacturingDevelop viral clearance strategy and oversee studies with contract laboratories, including protocol development, technical review, data interpretation, and report approvalOptimize purification platforms and deepen process understanding through mechanistic modeling, statistical design of experiments, data analytics, and targeted wet-lab studiesConceive and evaluate novel, advanced bioprocess technologies that are in line with the group’s strategyMaintain current scientific knowledge by critically reviewing peer-reviewed literature, regulatory guidance, patents, and emerging industry trends, and translate relevant advances into program strategy, experimental design, and platform developmentSeize opportunities to pursue project relevant leads that are in line with the group’s strategyWrite technical publications, reports, presentations, and regulatory filings including publishing research in peer-reviewed journals and presenting work at scientific conferencesWork efficiently, collaboratively, and cross-functionally to meet project deliverables and timelines.Understand and adhere to corporate standards regarding code of conduct, safety, appropriate handling of materials, and GxP compliance, where applicableMentor and train junior scientistsQualificationsBachelor’s Degree or equivalent education and typically 10+ years of experience, Master’s Degree or equivalent education and typically 8+ years of experience, PhD and 0+ years with relevant postdoctoral or industry experience (Education in Chemical Engineering, Biochemistry, Chemistry, or a closely related field)Demonstrated understanding of downstream bioprocess unit operations, including affinity, ion-exchange, and hydrophobic-interaction chromatography; depth and virus filtration; tangential-flow filtration; and formulation or bulk drug substance handlingProven ability to work independently, effectively plan and execute work activities, and prioritize task completion to meet project deadlines in a fast-paced environmentDemonstrated depth of scientific knowledge in protein biochemistry, separation science, and/or bioprocess engineering, with the ability to critically evaluate scientific literature and apply relevant findings to hypothesis-driven experimental design, data interpretation, and technical decision-makingAble to organize, analyze, visualize, and interpret complex process and analytical data using tools such as JMP, Python, R, or comparable softwareMust be forward-thinking and be able to lead and contribute to scientific/technical discussions and innovationAble to independently learn, understand and execute novel, advanced scientific techniquesMust have excellent attention to detail and ability to keep detailed written recordsProven record of authoring publications, technical reports, regulatory documents, and/or presentationsHas strong communication skills including verbal, written, and scientific data presentationAble to work collaboratively within and outside of the groupPreferred:Hands-on experience developing purification processes for monoclonal antibodies, multispecifics, antibody-drug conjugates, or other antibody-like molecules at laboratory, pilot, and/or GMP scaleExperience developing scalable purification processes and applying quality-by-design principles, including identification of critical quality attributes and process parameters, is requiredProven experience in mechanistic modeling of downstream purification unit operations (e.g. GoSilico, CADET, gPROMS or similar framework) including chromatography separations and/or membrane separationsProven experience in programming liquid-handling robots (like Tecan or Hamilton systems) and automated chromatography platforms (like ÄKTA) to execute high-throughput screening and purification studies.Proficient in writing methods and operating AKTA chromatographic instruments (such as AKTA Avant, AKTA Pure, AKTA Pilot, AKTA Ready or similar)Has a strong understanding of statistical analysis, such as standard deviation and analysis of varianceFamiliarity with design of experiment (DoE) software, such as JMPHas a strong understanding of analytical techniques, such as SEC, RP, SDS, icIEF, mass spectroscopy, and ELISAHas previous regulatory filing experience (e.g. IND/IMPD)Experience authoring process-development reports, technology-transfer protocols, process characterization summaries, and CMC sections supporting regulatory submissionsDemonstrated scientific aptitude through authorship of peer-reviewed publicationsFamiliarity with pharmaceutical regulations and guidelines (e.g. GMP and ICH Guidelines)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 and serving our community. Equal Opportunity Employer/Veterans/Disabled.US & Puerto Rico only - to learn more, visithttps://www.abbvie.com/join-us/equal-employment-opportunity-employer.htmlUS & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:https://www.abbvie.com/join-us/reasonable-accommodations.htmlBy clicking the link above or any third-party link within this posting, you are leaving this site and going to a third-party website where the third-party website's terms and privacy policy applyI'm interestedI'm interestedPrivacy Notice
