Principal Research Scientist II, Parenteral PDS&T Analytical Development

AbbVie Parenteral Product Development Science & Technology (PDS&T) is a global organization responsible for all CMC activities related to the development and commercialization of AbbVies parenteral 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 clinical proof of concept through commercial product launch.  We are a world-class team of scientists and leaders driving the advancement of industry-leading analytical capabilities and AbbVies pipeline of innovative medicines.  Careers in AbbVie Parenteral PDS&T provide opportunities to work with global and cross-functional teams to develop innovative products and drive exceptional science.

The Analytical Development group is responsible for programs that are transitioning from development stage to optimization and commercialization.  We develop and implement commercial analytical control strategies including final method optimization and validation ensuring all analytical methods are fit for use in commercial QC laboratories.  Key deliverables also include product control strategies informed by analytical data and method understanding; comprehensive data packages that drive product and process understanding; stability studies to establish commercial product dating; and approvable marketing application submission content. 

We are looking for a highly motivated person who can serve as the Analytical Lead for late stage biologics parenteral products.  The candidate will develop strategies and manage timelines for the analytical deliverables of their given development programs.  The candidate will also interface with key Analytical stakeholders across organizations as well as cross-functional CMC business partners in the characterization of biologics compounds and provide key data for regulatory submissions including IND/IMPD amendments and BLA filings.

Key Responsibilities

• Develop analytical strategies and communicate with PDS&T business partners for experimental execution in support of stability studies comparability studies and extended characterization of biologics products (e.g. mAbs ADCs bispecifics).
• Interpret and identify data trends in key analytical release and stability assays.
• Develop robust analytical control strategies including commercial specifications.
• Author regulatory filings (including IND and BLA filings) and address questions from health authorities.
• Proactively advise and share knowledge/expert opinions with peers and senior management. Mentor peers in project management and development of analytical strategies.
• Collaborate with third party laboratories and manufacturers for outsourced programs to ensure CMC timelines are met.
• Author and/or review key regulatory documents technical memos and reports.
• Encourage ideas for continuous improvement activities and initiatives within work group.

Qualifications :

• PhD (8 years) Masters Degree (14 years) or Bachelors Degree (16 years) in scientific discipline (e.g. Analytical 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).
• Experience in analytical technologies (HPLC UV-Vis compendial tests and KF).  Experience in bioanalytical techniques including SEC CEX CE-SDS icIEF peptide mapping bioassay ELISA subvisible particle analysis for parenteral drug products preferred.
• Experienced in laboratory systems (LIMS CDS ELN) preferred.
• Statistical knowledge and experience are preferred e.g. capability analysis and design of experiments (DOE) methodologies.
• Solid understanding of protein chemistry and biochemistry particularly as related to biologics drug development is preferred.
• Ability to multitask and work within timelines.
• Demonstrated scientific writing skills and strong verbal communication skills.

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. 

• This job is eligible to participate in our long-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 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 and serving our community. Equal Opportunity Employer/Veterans/Disabled. 

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Work :

No

Employment Type :

Full-time