Senior Scientist II, Biologics Analytical R&D
Senior Scientist II, Biologics Analytical R&D
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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 AbbVies 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 AbbVies 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 AbbVies 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 experience is required with relevant experience or MS with 8 years of experience.
- Qualification for Senior Scientist II: Ph.D. with 4 years of 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 ambiguitykey 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 :
- This is an on-site opportunity based in AbbVies Abbott Park location in IL.
- Leveling will be commensurate to experience.
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.
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No
Employment Type :
Full-time
Employment Type
Full-time
