About the Company
AbbVie is a global biopharmaceutical company committed to discovering and delivering innovative medicines 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, eye care, virology, women’s health and gastroenterology, in addition to products and services across our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com.
Job Description
We are seeking a highly skilled and detail-oriented Methods Validation Chemist with a specialized focus on regulatory compliance to join our R&D team in Naperville, IL. The successful candidate will be responsible for the design, execution, and documentation of analytical method validation studies for various pharmaceutical products in accordance with ICH, FDA, and other relevant regulatory guidelines. This role requires a strong understanding of cGMP principles, analytical chemistry techniques, and regulatory submission requirements. You will play a critical role in ensuring the quality and integrity of our analytical data, contributing directly to the successful development and commercialization of new therapeutics.
Key Responsibilities
- Design and execute analytical method validation protocols for new and existing methods, including but not limited to HPLC, GC, UV/Vis, KF, dissolution, and titrimetric assays.
- Perform method transfers and verification studies in compliance with internal and external regulatory standards.
- Draft comprehensive validation reports, ensuring all data, results, and conclusions are accurately presented and meet regulatory expectations.
- Collaborate with R&D, Quality Control, and Regulatory Affairs teams to define validation strategies and address analytical challenges.
- Troubleshoot analytical methods and instrumentation issues, proposing and implementing effective solutions.
- Stay current with evolving regulatory guidelines (e.g., ICH Q2(R1), USP, EP, JP) and industry best practices for method validation.
- Participate in laboratory investigations, out-of-specification (OOS) and out-of-trend (OOT) investigations, and root cause analyses.
- Maintain laboratory equipment in a qualified state and ensure calibration and maintenance schedules are adhered to.
- Support regulatory submissions by providing validated method data and responding to agency queries.
- Provide technical guidance and training to junior chemists as needed.
Required Skills
- Ph.D. in Analytical Chemistry, Chemistry, or related scientific discipline with 3+ years of relevant experience, OR Master’s degree with 5+ years, OR Bachelor’s degree with 7+ years of relevant experience.
- Proven experience in analytical method validation within the pharmaceutical or biopharmaceutical industry.
- In-depth knowledge of ICH Q2(R1) guidelines and other relevant regulatory requirements (FDA, USP, EP, JP).
- Proficiency in a wide range of analytical techniques, including HPLC, GC, dissolution, UV/Vis, and KF.
- Strong understanding of cGMP principles and data integrity requirements.
- Excellent technical writing and communication skills, with experience drafting validation protocols and reports.
- Demonstrated ability to troubleshoot analytical methods and instrumentation.
Preferred Qualifications
- Experience with LIMS and electronic lab notebook (ELN) systems.
- Prior experience in a GLP or cGMP regulated environment.
- Familiarity with statistical software for data analysis (e.g., JMP, Minitab).
- Experience with method development and optimization.
- Knowledge of Quality by Design (QbD) principles in analytical method development and validation.
Perks & Benefits
- Competitive salary and performance-based bonuses.
- Comprehensive health, dental, and vision insurance plans.
- 401(k) retirement plan with company match.
- Generous paid time off and holidays.
- Opportunities for professional development and continuing education.
- On-site fitness centers and wellness programs.
- Employee assistance program and mental health support.
- Tuition reimbursement program.
- Relocation assistance (if applicable).
How to Apply
If you are interested in this position, please click the "Apply Now" button below. To ensure your application is properly considered, please prepare the following:
- An up-to-date Resume or CV
- A brief cover letter summarizing your experience and motivation
Applications are reviewed on a rolling basis. Only shortlisted candidates will be contacted for an interview.
⚠️ Important Disclaimer
Welcome to Westford Trust. We publish job opportunities aggregated from public sources, employers, and job portals. We never charge any fees to access or use our website; all information is provided entirely for free.
Westford Trust does not directly offer or manage these positions, nor are we directly involved in the hiring process for the vacancies published on https://career.westfordtrust.com.
If you suspect a fraudulent listing or have any questions, please contact us at techturna@gmail.com.