Principal Research Scientist I Biologics Analytical RD External Programs
Principal Research Scientist I Biologics Analytical RD External Programs
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Job Description
AbbVie Biologics Analytical Research & Development (Biologics ARD) is a global analytical sciences organization responsible for CMC analytical activities related to the development of AbbVies therapeutic biologic products. Our scope includes AbbVies diverse pipeline of innovative therapeutic biologics medicines including monoclonal antibodies antibody drug conjugates (ADC) and other novel modalities and spans from the selection of Discovery candidate molecules through the transition of analytical methods and testing to operations partners for late stage development. We are building a worldclass team of scientists and leaders who will drive the advancement of industryleading analytical capabilities and make meaningful contributions to advance AbbVies pipeline of innovative medicines. Careers in AbbVie Biologics ARD provide unique opportunities to work with global and crossfunctional teams to drive exceptional science and innovative product development strategies.
The Analytical Development External Programs group within Biologics ARD is responsible for early development (through clinical proof of concept) of programs with outsourced analytical activities. The candidate will serve as analytical lead on internal CMC teams and will work with external parties on method development optimization validation/transfer and testing of clinical supplies to meet analytical deliverables for their given development programs. In collaboration with crossfunctional partners the lead will define analytical strategies for formulation and process development studies. Key deliverables include robust analytical methods clinical supplies release testing and stability studies to establish clinical product dating product control strategies informed by analytical data and method understanding comprehensive data packages that drive product and process understanding and regulatory submission content.
Major Responsibilities
- As analytical lead develop analytical strategies and communicate to Analytical R&D functions and CMC business partners for experimental in support of stability studies product analytical control strategies comparability studies and extended characterization of biologics.
- Collaborate with third party laboratories to ensure CMC timelines are met.
- Interpret and identify data trends in key analytical release and stability assays.
- Author and/or review key regulatory documents laboratory data technical memos and reports.
- Proactively advise and share knowledge/expert opinions with peers and senior management. Mentor peers in project management and development of analytical strategies.
- Demonstrate scientific excellence in analytical characterization of biologics internally and externally and build and foster an active network of consortia collaborations
- Brainstorm ideas for continuous improvement activities and lead/participate in initiatives.
- Understand and adhere to corporate standards regarding code of conduct safety and GXP compliance.
Qualifications :
- BS 14 years); MS 12 years) or PhD 6 years) in Chemistry Biochemistry or Biology with previous work experience 6 years) in a pharmaceutical laboratory setting.
- Preferred candidate should have experience in project management/leadership of analytical development activities for biologic compounds (mAbs antibody drug conjugates and/or fusion proteins).
- Preferred candidate should have experience managing third party laboratories.
- Experience and strong knowledge of protein HPLC (e.g. SEC IEX HIC) capillary electrophoresis and other separation techniques as applied to protein analysis.
- Demonstrated scientific writing skills and excellent verbal communication skills.
- Experience in laboratory systems (LIMS CDS ELN) preferred.
- Statistical knowledge and experience are preferred e.g. capability analysis gauge R&R and design of experiments (DOE) methodologies.
Key AbbVie Competencies:
- Interact well with diverse groups within function and maintain strong working relationships with internal and external collaborators to enable higher performance.
- Learns fast grasps the essence and can change course quickly where indicated.
- Raises the bar and is never satisfied with the status quo.
- Creates a learning environment open to suggestions and experimentation for improvement.
- Embraces the ideas of others nurtures innovation and manages innovation to reality.
Level and compensation will be commensurate with experience.
Additional Information :
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
- Onsite role with hybrid flexibility based out of North Chicago IL.
- Level and compensation will be commensurate with experience.
- 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 shortterm incentive programs.
- This job is eligible to participate in our longterm 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 Companys sole and absolute discretion unless and until paid and may be modified at the Companys 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 AbbVies 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.
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No
Employment Type :
Fulltime
Employment Type
Full-time
