Senior Scientist I, Analytical Chemistry
About The Position
AbbVie’s Product Development Science and Technology (PDS&T) Analytical organization is seeking a Senior Scientist to independently develop and execute analytical methods supporting robust manufacturing process development for clinical-phase and commercial products. The role contributes to product quality and efficacy and works collaboratively with process and product development, CMC, process engineering, internal and external manufacturing, quality assurance, supply chain, and Operations Manufacturing Sites. The scientist leads analytical project work, including method development and validation, analytical control strategies, specification justification, data generation, regulatory submissions, technology transfer, and investigations. The position applies analytical separation and detection techniques to complex impurity profiling and research and development involving synthetic molecule drug products, active pharmaceutical ingredients, intermediates, starting materials, and impurities. It also supports new product development through advanced method development and validation, technical transfer packages, and technical data for regulatory requirements. The role requires substantial autonomy in laboratory research and method development, interpreting multidisciplinary data, designing follow-on experiments, communicating results to project teams, and maintaining productive, safe, and compliant laboratory practices. The scientist may initiate scientifically meaningful investigations that can be incorporated into development programs.
Requirements
- Ph.D. in Analytical Chemistry with 0–4 years of related industry experience is highly preferred; alternatively, a bachelor’s degree or equivalent education with typically 10 years of experience, a master’s degree or equivalent education with typically 8 years of experience, or a Ph.D. with no experience is stated as acceptable.
- Understanding of cGMP and current regulatory requirements is highly preferred.
- Strong chromatography knowledge and demonstrated ability to independently develop, troubleshoot, and improve methods.
- Hands-on experience with HPLC/GC analysis and method development, along with expertise in and fundamental understanding of spectroscopic techniques.
- Self-motivated, hardworking, detail-oriented, and able to work in a fast-paced team environment.
- Experience using computerized data-handling systems, data analysis, and statistical approaches.
- Strong written and oral communication skills and ability to interact effectively with interdisciplinary scientists and engineers.
Nice To Haves
- Practical knowledge of organic structures, chemical reactions, functional groups, and modern spectroscopic techniques as applied to small-molecule analytical analysis.
- Familiarity or experience measuring drug release from complex drug delivery matrices.
Responsibilities
- Develop analytical methods, testing procedures, and analytical control strategies to advance pipeline candidates.
- Lead analytical project activities, including method development and validation, control strategy development, specification justification, data generation, regulatory submissions, technology transfer, and investigations.
- Apply analytical separation and detection modes to complex impurity profiling of pharmaceutical products and to understand emerging cGMP manufacturing processes.
- Conduct research and development studies involving synthetic molecule drug products, active pharmaceutical ingredients, intermediates, starting materials, and impurities using a range of analytical techniques.
- Support new product development through advanced method development and validations, technical transfer packages, and technical data for regulatory requirements.
- Perform laboratory research and method development autonomously, requiring minimal direction or supervisor interaction.
- Formulate conclusions and design follow-on experiments based on multidisciplinary data.
- Initiate scientifically meaningful and reliable investigations that can be incorporated into development programs.
- Process, interpret, and visualize data to facilitate project team decisions.
- Communicate and collaborate with cross-functional groups and departments.
- Demonstrate scientific initiative and creativity and maintain high laboratory productivity.
- Follow corporate standards for conduct, safety, material handling, controlled drug and radioactive compounds, and applicable GxP requirements.
Benefits
- Paid time off, including vacation, holidays, and sick time.
- Medical insurance.
- Dental insurance.
- Vision insurance.
- 401(k).
- Eligibility for short-term incentive programs.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
Ph.D. or professional degree
