Senior Research Associate- Analytical Development (Formulations)

Walter Bushnell; Gurugram District; Sur place; INR 1 400 000 - 2 600 000; Plein temps

Résumé du poste

Walter Bushnell in Gurgaon is seeking an Analytical R&D Senior Scientist in Formulation to lead analytical method development and validation for various formulations, ensuring quality and regulatory compliance.

You will design experiments, interpret data, mentor juniors, and collaborate with R&D, QA, and Regulatory Affairs to meet project goals, while maintaining GMP standards.

Qualifications

• Bachelor’s or Master’s in Chemistry or analytical chemistry required.
• 4–10 years of hands-on experience in Analytical R&D.
• Experience in method development and validation.
• Familiarity with GMP/ICH guidelines.

Responsabilités

• Design, develop, and validate analytical methods for release and stability testing.
• Perform complex sample preparation and analyses across formulations.
• Plan, execute, and supervise stability studies and data review.
• Document experiments and prepare regulatory-ready reports.
• Ensure GMP/ICH compliance in all activities.
• Lead cross-functional teams and mentor junior scientists.
• Oversee lab operations and instrument maintenance.
• Collaborate with R&D, QA, and Regulatory Affairs.

Connaissances

Analytical method development

Regulatory compliance

Leadership

Technical writing

Problem solving

Formation

Bachelor's/Master's in Chemistry

Outils

HPLC

GC

LC-MS

Spectroscopy

Description du poste

Hiring for Analytical R&D- Formulation || Gurgaon Location.

• Education: Typically requires a degree in chemistry, analytical chemistry, or a related scientific field, often at the Bachelors /Master's
• Experience: 4 to 10 years

• An Analytical R&D Senior Scientist in formulation is responsible for developing and validating analytical methods, conducting complex testing on various formulations, and ensuring product quality and stability. This includes designing and executing experiments, interpreting data, mentoring junior scientists, and collaborating with cross-functional teams to meet project and regulatory goals.

Responsibilities

• Method development and validation: Design, perform, and validate new analytical methods for release and stability testing, ensuring compliance with regulatory guidelines like ICH.
• Testing and analysis: Independently perform complex sample preparation and analytical testing on different formulations, analyze and interpret data, and troubleshoot issues.
• Stability studies: Plan, execute, and supervise stability studies, including data review and the investigation of out-of-specification (OOS) or out-of-trend (OOT) results.
• Documentation: Accurately document all experimental data, write technical reports, and prepare and review analytical documents for regulatory submissions.
• Regulatory compliance: Ensure all work complies with Good Manufacturing Practices (GMP), ICH guidelines, and other relevant regulatory standards.
• Project leadership and collaboration: Work with cross-functional teams (R&D, QA, Regulatory Affairs) to align on product development, and communicate project status and technical issues.
• Mentorship and training: Mentor and train junior scientists on analytical techniques and best practices.
• Laboratory management: Oversee and maintain laboratory equipment, optimize lab operations, and support instrument troubleshooting.

Key skills

• Expertise in analytical techniques such as chromatography (HPLC, GC), mass spectrometry (LCMS), and spectroscopy.
• Strong knowledge of formulation development and stability testing.
• Deep understanding of regulatory requirements (e.g., ICH, USFDA).
• Excellent technical writing, communication, and problem-solving skills.
• Leadership and mentoring abilities.
• Attention to detail and strong organizational skills