Job DescriptionJob DescriptionCompany 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 atwww.abbvie.com. Follow @abbvie onX,Facebook,Instagram,YouTube,LinkedInandTik Tok.
Job Description
* Lead and mentor a team of 10-12 scientists specializing in establishing separation-based assays including HPLC (e.g. SEC, IEX, RPLC), capillary electrophoresis (CE, icIEF), etc. for QC lab implementation to support GMP release and stability testing and for sample testing in PDS&T - Analytical Development to support biologics DS process development, characterization, validation as well as GMP manufacturing investigation activities. Develop high-throughput analytical methods and drive timely delivery of high-quality testing results.
* Serve as a primary contact for Analytical Development in AbbVie's CMC teams, supporting both early and late-stage biologics pipeline assets. Balance stakeholder expectations between PDST and other AbbVie analytical functions to ensure effective collaboration.
* Develop, communicate, and implement analytical strategies with broader PDS&T analytical functions and CMC business partners. Oversee experimental execution, development, qualification, validation, and transfer of robust analytical methods for QC lab as well as analytical control strategy development.
* Guide team to evaluate and select effective analytical technologies and methods for meeting program needs. Evaluate and interpret data trends in release and stability assays. Demonstrate scientific excellence in the analytical characterization of biologics and ensure robust documentation of study findings.
* Author and review analytical sections of IND/BLA filings for early and late-stage programs, provide response support to agency information request. Ensure all submissions comply with regulatory requirements and industry standard.
* Collaborate with other analytical teams in R&D and PDS&T on program transition, workflow and program strategic alignment. Provide guidance to peers in project management, analytical strategy development, and technical skills related to separation techniques.
* Communicate project strategies, issues, and risks to relevant teams. Promote proactive risk resolution within and across functional areas to advance project objectives.
* Build a high-performing team to proactively seek method and product understanding, build robust product knowledge and new capability, and advance science and innovation. Lead team to actively publish novel study findings at internal and external conferences and journals.
Qualifications
* MS or PhD in chemistry, biology, biochemistry, chemical engineering, or related technical discipline. Minimum of 12+ years (MS) or 8+ years (PhD) of professional experience working in biotech/pharmaceutical setting.
* Proven experience managing and leading analytical development activities for biologic development, including mAbs, bispecifics, antibody-drug conjugates, and fusion proteins.
* Expertise in protein and impurity analysis techniques such as HPLC, capillary electrophoresis, and other relevant methods. Experience with mass spectrometry and ELISA is a Plus.
* Familiarity with USP/ICH guidelines for method development, qualification, and validation. Extensive experience in authoring, reviewing regulatory submissions and responding to agency information requests.
* Strong technical and people leadership skills, and demonstrated ability to foster an engaging, inclusive and collaborative team environment.
* Ability to quickly comprehend and adapt to new situations, with an open mindset and can-do attitude, demonstrating agility where necessary to address evolving project needs.
* Excellent communication, organization and inter-personal skills, effectively managing relationships to enhance team decision-making.
Additional Information
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state orlocal law:
* The compensation range described below is the range of possible base pay compensation that the Companybelieves ingood faith it will pay for this role at the timeof this posting based on the job grade for this position.Individualcompensation paid within this range will depend on many factors including geographic location, andwemay ultimatelypay more or less than the posted range. This range may be modified in thefuture.
* We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick),medical/dental/visioninsurance and 401(k) to eligibleemployees.
* This job is eligible to participate in our short-term incentiveprograms.
* This job is eligible to participate in our long-term incentiveprograms
Note: No amount of payis considered to bewages or compensation until such amount is earned, vested, anddeterminable.The amount and availability of any bonus,commission, incentive, benefits, or any other form ofcompensation and benefitsthat are allocable to a particular employee remains in the Company's sole andabsolutediscretion unless and until paid andmay be modified at the Company’s sole and absolute discretion, consistent withapplicable 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.html
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