AbbVie
Senior Scientist I, Analytical Development Documentation
AbbVie, North Chicago, Illinois, us, 60086
Company DescriptionAbbVie'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 Twitter, Facebook, Instagram, YouTube and LinkedIn.
Job DescriptionAbbVie Parenteral Product Development Science & Technology (PDS&T) is a global organization responsible for all CMC activities related to the development and commercialization of AbbVie's parenteral products. Our scope includes AbbVie's 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 AbbVie's 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 lead final method development, optimization, and validation, ensuring all analytical methods are fit for use in commercial QC laboratories. Key deliverables include product control strategies informed by analytical data and method understanding; robust analytical methods suitable for commercial QC labs; comprehensive data packages that drive product and process understanding; stability studies to establish commercial product dating; and approvable marketing application submission content. This position will work primarily outside of the laboratory, enhancing compliance and knowledge management for pipeline programs.
Key Responsibilities:
Provide support to Analytical Leads and Lab Managers across multiple projects including, but not limited to:
Creating/reviewing/verifying specification reports and/or LIMS-based specifications
Creating/reviewing/verifying stability study protocols and/or reports
Creating/reviewing/verifying technical reports, technical memos, and test slips
Performing change management for document updates
Reviewing/verifying IND/IMPD/BLA sections using source documents provided by the Analytical Leads and Lab Managers
Assisting with compiling information for special requests from health authorities (e.g., chromatographic overlays, data needed for responding to questions, etc.)
Qualifications
PhD (0+ years), Master’s Degree (8+ years), or Bachelor’s Degree (10+ years) in scientific discipline (e.g., Analytical Chemistry, Biochemistry, or Biology)
Scientific writing skills and strong verbal communication skills
Ability to manage and prioritize multiple projects simultaneously, and to work within timelines
Knowledge and experience in analytical method development, with exposure to cGMP’s, international pharmaceutical guidelines, and the CMC content of regulatory submissions
Experience documenting and reviewing laboratory notebooks in compliance with Good Laboratory/Manufacturing Practices
Experience in review and/or preparation of source documents and the CMC sections of regulatory submissions is a plus
Practical experience and knowledge of protein HPLC (e.g., SEC, IEX, HIC), capillary electrophoresis, and other separation techniques as applied to protein analysis is 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.
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 AbbVie’s 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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Job DescriptionAbbVie Parenteral Product Development Science & Technology (PDS&T) is a global organization responsible for all CMC activities related to the development and commercialization of AbbVie's parenteral products. Our scope includes AbbVie's 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 AbbVie's 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 lead final method development, optimization, and validation, ensuring all analytical methods are fit for use in commercial QC laboratories. Key deliverables include product control strategies informed by analytical data and method understanding; robust analytical methods suitable for commercial QC labs; comprehensive data packages that drive product and process understanding; stability studies to establish commercial product dating; and approvable marketing application submission content. This position will work primarily outside of the laboratory, enhancing compliance and knowledge management for pipeline programs.
Key Responsibilities:
Provide support to Analytical Leads and Lab Managers across multiple projects including, but not limited to:
Creating/reviewing/verifying specification reports and/or LIMS-based specifications
Creating/reviewing/verifying stability study protocols and/or reports
Creating/reviewing/verifying technical reports, technical memos, and test slips
Performing change management for document updates
Reviewing/verifying IND/IMPD/BLA sections using source documents provided by the Analytical Leads and Lab Managers
Assisting with compiling information for special requests from health authorities (e.g., chromatographic overlays, data needed for responding to questions, etc.)
Qualifications
PhD (0+ years), Master’s Degree (8+ years), or Bachelor’s Degree (10+ years) in scientific discipline (e.g., Analytical Chemistry, Biochemistry, or Biology)
Scientific writing skills and strong verbal communication skills
Ability to manage and prioritize multiple projects simultaneously, and to work within timelines
Knowledge and experience in analytical method development, with exposure to cGMP’s, international pharmaceutical guidelines, and the CMC content of regulatory submissions
Experience documenting and reviewing laboratory notebooks in compliance with Good Laboratory/Manufacturing Practices
Experience in review and/or preparation of source documents and the CMC sections of regulatory submissions is a plus
Practical experience and knowledge of protein HPLC (e.g., SEC, IEX, HIC), capillary electrophoresis, and other separation techniques as applied to protein analysis is 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.
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 AbbVie’s 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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