Analytical Scientist - AR&D

Job Title: Senior Scientist (Scientist-III) – Analytical R&D

Summary:

An industry leading pharmaceutical manufacturing firm is seeking a Senior Scientist - AR&D to utilize advanced analytical technologies to design and execute development activities across all drug development phases. As a key CMC team member, they will contribute to strategies, collaborate cross-functionally, and solve complex problems. Responsibilities include developing, validating, and transferring analytical methods for drug substances, products, and excipients. The Senior Scientist will independently manage multiple projects, ensure timely delivery, and maintain GLP/GMP documentation standards. Additionally, they will conduct reverse engineering of competitive products, support various R&D activities, and mentor junior staff.

Key Responsibilities:

• Lead and manage analytical development activities throughout all stages of drug development.
• Develop, validate, and transfer analytical methods for drug substances, drug products, and excipients.
• Operate and troubleshoot a variety of analytical instruments, including UPLC, HPLC, GC, UV, FT-IR, dissolution, Karl Fischer, mass spectrometers, laser, and more.
• Identify and resolve potential analytical or project-related issues proactively
• Review, approve, and prepare high-quality analytical data, technical reports, and methods.
• Provide mentorship and training to junior team members.
• Write and review protocols, reports, and technical documents related to method development and validation.
• Collaborate actively within CMC sub-teams, providing valuable data to guide decision-making, solving technical challenges, and project milestones.
• Stay current with cutting-edge developments in pharmaceutical and analytical sciences

Requirements:

Education and Experience:

• Bachelor’s degree in Chemistry or a related pharmaceutical science with 5 -7 years of experience in analytical method development and validation.
• Alternatively, a Master’s degree in Chemistry or a related field with 3 -5 years of relevant experience.
• Deep understanding of regulatory guidelines governing analytical method development and validation for pharmaceuticals.
• Expertise in Good Manufacturing Practices (GMP), FDA/ICH guidelines, and compendial references (USP/Ph. Eur., etc.).
• Experience with laboratory software such as Empower and Chemstation.(preferred)
• Familiarity with management systems like Labvantage.(referred)

Knowledge, Skills, and Abilities:

• Strong communication skills, both verbal and written, to clearly articulate technical concepts.
• Strong interpersonal skills, with the ability to foster productive relationships with peers and direct reports.
• Demonstrated focus on continuous improvement and innovation in analytical practices.
• In-depth knowledge of cGMP, FDA, and international regulatory standards.
• Proficiency in Microsoft Office and laboratory software for documentation and data analysis.
• Commitment to maintaining a safe and environmentally responsible work environment.