Company 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

DEPARTMENT DESCRIPTION

AbbVie Product Development Science & Technology -Analytical Sciences is a global analytical science organization responsible for all CMC analytical activities related to the clinical development and commercialization of AbbVie’s pharmaceutical and other products. Our scope includes AbbVie’s diverse pipeline of innovative small molecule medicines, including New Chemical Entities (NCEs), Antibody Drug Conjugate (ADC) drug linkers, peptides and oligonucleotides and spans from clinical development to commercial product support. 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 and ensure the commercial manufacturing success.

JOB DESCRIPTION:

We are seeking a highly motivated, experienced scientist with strong scientific and leadership experience to support the development of small molecule and peptide drug candidates in both clinical and commercialization stages. The candidate should have extensive expertise in oral drug product development, analytical method development, dissolution, biopharmaceutics, and Physiologically Based Pharmacokinetic (PBPK) modeling.
He/ She should be able to conduct research and/or project activities by effectively designing and performing experiments, mentoring, guiding and/or supervising scientific personnel. He/she will advance fundamental understanding of drug release and product performance by developing the bioequivalence safe space and/or IVIVC using physiologically based biopharmaceutics modeling through close collaborations with key partners.
He/she will establish collaborative and productive working relationships with key partner organizations to define successful process development strategies. He/he will effectively manage interfaces to ensure seamless transition of research programs into late-stage clinical development and technology transfers to commercial manufacturing and testing sites.

Qualifications

• Ph.D. with at least 8 years of relevant pharma/biotech industry experience or master’s degree with at least 14 years of relevant industry experience or bachelor’s degree with at least 16 years of relevant industry experience.
• Extensive knowledge and solid understanding of the various scientific disciplines, including dissolution, biopharmaceutics, pharmacokinetics, analytical control strategies and specifications, formulation development, and regulatory filings.
• Hands-on experience with method development along with fundamental understanding and working knowledge of various analytical techniques, such as UHPLC and dissolution.
• Experience in the use of GastroPlus or other PBPK simulation software for building PBPK models.
• In depth knowledge of relevant regulations and interactions with regulatory agencies. Filing experience with in Vitro-in Vivo extrapolation (IVIVC or IVIVR or safe space) is a plus.
• Self-motivated, hard-working, detail-oriented individual able to work in a fast-paced team environment.
• High-quality written and oral communication skills and ability to interact effectively with interdisciplinary scientists and engineers.
• A fast learner who grasps the “essence” and can change courses quickly where indicated.
• A problem solver who demonstrates creative ’out of the box’ thinking to solve difficult problems.
• Strong negotiating, influencing, and leadership skills

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. Salary: $137,500 - $261,000
• 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 program

• Leads analytical development for late-stage development programs in a cross-functional team setting.
• Establishes industry-leading analytical capabilities to support process and formulation development, technology transfer and post-approval changes.
• Responsible for development, validation and transfer of analytical methods aligned with the strategies.
• Applies in-vitro dissolution and PBPK models to establish in vitro-in vivo correlations and use physiologically based biopharmaceutics (PBBM) modeling to establish a safe space.
• Drives cross-functional initiatives among formulation development, analytical, clinical pharmacology and regulatory-CMC on biowaivers and biopharmaceutics risk assessment.
• Drives fundamental understanding of drug release and product performance through in vitro drug release testing, modeling and material science and characterization.
• Solves difficult and highly complex technical issues for products in development or commercial space in an evolving regulatory landscape.
• Works collaboratively across R&D and Operations to align and influence a broad range of development strategies that directly support drug development programs.
• Leads interactions with regulatory agencies in CMC development area and delivers regulatory filing packages
• Identifies, evaluates, and proposes both internal and external collaborations to drive scientific innovation and shared learning.
• Understands and complies with AbbVie safety, quality and regulatory policies and government regulations.

Qualifications

• Ph.D. with at least 8 years of relevant pharma/biotech industry experience or master’s degree with at least 14 years of relevant industry experience or bachelor’s degree with at least 16 years of relevant industry experience.
• Extensive knowledge and solid understanding of the various scientific disciplines, including dissolution, biopharmaceutics, pharmacokinetics, analytical control strategies and specifications, formulation development, and regulatory filings.
• Hands-on experience with method development along with fundamental understanding and working knowledge of various analytical techniques, such as UHPLC and dissolution.
• Experience in the use of GastroPlus or other PBPK simulation software for building PBPK models.
• In depth knowledge of relevant regulations and interactions with regulatory agencies. Filing experience with in Vitro-in Vivo extrapolation (IVIVC or IVIVR or safe space) is a plus.
• Self-motivated, hard-working, detail-oriented individual able to work in a fast-paced team environment.
• High-quality written and oral communication skills and ability to interact effectively with interdisciplinary scientists and engineers.
• A fast learner who grasps the “essence” and can change courses quickly where indicated.
• A problem solver who demonstrates creative ’out of the box’ thinking to solve difficult problems.
• Strong negotiating, influencing, and leadership 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. Salary: $137,500 - $261,000
• 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 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.htm