Description

ICompany 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 X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.

Job Description

Group

AbbVie Biologics Analytical Research & Development (Biologics Analytical R&D) is a global analytical sciences organization responsible for all CMC analytical activities related to the development of AbbVie's pharmaceutical products. Our Early Analytical Development team owns analytical strategy, method development, release & stability testing for IND-enabling biologic programs developed internally, partnering closely with Drug Substance, Drug Product, Regulatory Affairs, QA and Process Development Sciences & Technology.

Our scope includes AbbVie's diverse pipeline of innovative therapeutic biologic medicines and spans from the selection of Discovery candidate molecules through the transition of analytical methods and testing to commercial labs to support product launch. We are building a world-class team of scientists and leaders who will drive the advancement of industry-leading analytical capabilities and make meaningful contributions to advance AbbVie's pipeline of innovative medicines. Careers in AbbVie Biologics Analytical R&D provide unique opportunities to work with global and cross-functional teams to drive exceptional science and innovative product development strategies.

The biologics early analytical development group develops state-of-the-art analytical techniques for analysis of therapeutic proteins and other novel biologic molecules using separation science and other biophysical techniques. We are looking for diverse candidates with strong scientific and leadership experience to join the AbbVie Analytical R&D team and can offer exciting and rewarding career opportunities for these candidates.

Overview

The candidate will focus on development and implementation of analytical assays for the analysis of complex biologics including antibodies, antibody drug conjugates, and new modalities. The candidate will use and develop a variety of analytical techniques including chromatography, electrophoresis, spectroscopy, and automated methods. The successful candidate will contribute to the development and testing of complex and automated assays and will contribute to the continuous improvement and innovation within the group.

Key Responsibilities

• Effectively function as a scientist, generating original technical ideas and research or development strategies.
• Develop and optimize early-stage analytical methods using HPLC/UHPLC, CE-SDS and other separation/biophysical techniques."
• Drive the development of automated workflows for liquid handling platforms to improve method robustness and throughput.
• Author CMC analytical sections of IND/IMPD filings and contribute to global regulatory strategy alongside Reg Affairs.
• Collaborate daily with DS, DP, QA, late-stage stakeholders, and external CROs to align on method readiness and data packages.
• Demonstrate the ability to resolve key project hurdles and assumptions by effectively utilizing available information and technical expertise.
• Independently responsible for project science within his/her area of expertise on one or more project teams leading the method development and validation for complex biologic therapeutics.
• Proactively seek out new information in the literature and incorporate this into individual projects as well as the overall program.

Qualifications

• Ph.D degree in Biochemistry, Analytical Chemistry, Pharmaceutical Sciences or a closely related discipline or MS degree with 8 years of experience.
  • Qualification for Senior Scientist I: Ph.D. with 0-4 years of industry experience is required with relevant experience or MS with 8 years of experience.
  • Qualification for Senior Scientist II: Ph.D. with 4+ years of industry experience is required with relevant experience or MS with 10 years of experience.
• Hands-on expertise with HPLC/UPLC and CE-SDS, plus working familiarity with Hamilton or Tecan liquid-handling platforms.
• Working knowledge of cGMP expectations for early clinical materials; routine QC execution is not expected.
• Experience applying chemometrics / multivariate data analysis (e.g., PCA, MVM) and statistics to model-based method development.
• Demonstrated record of independent thought, creativity and scientific accomplishment (e.g. peer reviewed journal publications, patents).
• Must have a solid understanding of protein/oligonucleotide chemistry and biochemistry, particularly as related to biologics drug development.
• Strong data and time organization/management skills coupled with strong interpersonal and effective communication skills for facilitating collaborations with a demonstrated ability to lead cross functional process development teams.
• Demonstrated scientific curiosity, creativity and comfort operating in ambiguity-key to inventing from scratch.
• Effective writer and communication of research or other regulatory materials.
• Experience with analytical Multivariate Analytical Procedures development and/or validation a plus.

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 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, 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.htmlI