About the Company
GlaxoSmithKline (GSK) is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people over the next 10 years. Our products are trusted by patients and healthcare professionals around the world. We are committed to delivering innovative medicines and vaccines.
Job Description
We are seeking a highly skilled and meticulous Methods Validation Chemist with a specialized focus on regulatory compliance to join our analytical development team in Durham, NC. The successful candidate will be responsible for the development, validation, and transfer of analytical methods used for quality control testing of raw materials, in-process samples, and finished pharmaceutical products, ensuring strict adherence to global regulatory guidelines (e.g., FDA, EMA, ICH). This role is critical in maintaining the integrity and compliance of our analytical testing processes and supporting new product introductions and lifecycle management.
Key Responsibilities
- Develop, optimize, and validate analytical test methods for new and existing pharmaceutical products, ensuring compliance with ICH guidelines (Q2(R1)) and other relevant regulatory standards.
- Perform analytical testing using a variety of techniques including High-Performance Liquid Chromatography (HPLC), Gas Chromatography (GC), UV-Vis Spectrophotometry, Fourier-Transform Infrared Spectroscopy (FTIR), Karl Fischer titration, dissolution testing, and various physical testing methods.
- Write and review comprehensive validation protocols, reports, and standard operating procedures (SOPs) in accordance with GxP and regulatory requirements.
- Collaborate effectively with Research & Development, Quality Control, and Regulatory Affairs teams to support product development, submission activities, and post-market changes.
- Troubleshoot method issues, perform thorough investigations into out-of-specification or out-of-trend results, and implement effective corrective and preventive actions (CAPAs) as needed.
- Stay abreast of current industry trends, emerging technologies, best practices, and evolving regulatory expectations related to analytical method validation and pharmaceutical quality.
- Provide technical expertise, guidance, and training to junior chemists and laboratory personnel.
- Ensure all laboratory activities are conducted in a cGMP/GLP compliant environment, maintaining meticulous records and data integrity.
- Participate in internal and external audits as a subject matter expert for method validation.
Required Skills
- Expertise in analytical method validation principles and ICH Q2(R1) guidelines.
- Proficiency with various analytical techniques including HPLC, GC, UV-Vis, FTIR, and KF.
- Strong understanding of cGMP/GLP regulations and pharmaceutical quality systems.
- Excellent technical writing and documentation skills for protocols, reports, and SOPs.
- Proven ability to troubleshoot complex analytical problems and lead investigations.
- Strong attention to detail, accuracy, and organizational skills.
- Effective communication (written and verbal) and teamwork abilities for cross-functional collaboration.
Preferred Qualifications
- Master's or Ph.D. in Chemistry, Analytical Chemistry, Biochemistry, or a closely related scientific field.
- Demonstrated experience with method transfer, method robustness studies, and method lifecycle management.
- Familiarity with electronic laboratory notebooks (ELN) and Laboratory Information Management Systems (LIMS).
- Prior experience working in a pharmaceutical manufacturing, contract research organization (CRO), or contract development and manufacturing organization (CDMO) setting.
Perks & Benefits
- Comprehensive health, dental, and vision insurance plans.
- 401(k) retirement plan with generous company match.
- Paid time off, including vacation, sick leave, and company holidays.
- Professional development and continuous learning opportunities, including tuition reimbursement.
- On-site fitness center, wellness programs, and employee assistance program.
- Performance-based bonuses and competitive compensation.
- Employee recognition programs.
- Subsidized cafeteria and healthy living options.
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.
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