Senior Associate Scientist, AR&D | Pfizer | Chennai

Job Description

• Contribute to the achievement of immediate work group goals and collaborate with other team members.
• Maintain a contemporary awareness of Global Business Practices, methods, specifications, Standard Operating Procedures, Pharmacopoeial trends, International conferences on Harmonization guidelines, and regulatory expectations.
• Work closely with analytical experts and project teams to provide timely support for chemists and formulators in the form of quality data that can be used in support of regulatory documentation of new drug applications.
• Assist in the maintenance and renewal of laboratory instruments, systems, or apparatus, and in the maintenance and continuous improvement of safe and effective working practices.
• Independently carry out all aspects of practical work necessary to provide the right-first-time results.
• Perform analytical method development, validation, and transfer activities for small molecules as well as complex formulations.
• Attend project team and brainstorming meetings and present data.
• Maintain written records of all experimental work in accordance with Good Lab Practices/ (Current) Good Manufacturing Practices (GLP/GMP) and departmental Standard Operating Procedures.
• Responsible for performing and troubleshooting cell-based and immunoassays, while applying these methods to a broad range of early and late-stage products in a Good Manufacturing Practices {also cGMP} environment.
• Complete professional-level chemistry and biochemistry assignments independently in support of programs, and investigations with minimal supervision while demonstrating cGMP and scientific principles.

Qualifications:

Must-Have

• Bachelor’s Degree
• 3+ years of experience
• Experience with laboratory data systems
• Provides attention to detail and is good at documentation Method validation experience
• Ability to extract relevant information from scientific literature, accurately record observations, facts, data, and conclusions during experimental work or Good Manufacturing Practices {also cGMP} investigations
• Good knowledge of fundamental organic chemistry, functional group recognition, and compound characterization with some experience using spectroscopic and chromatographic techniques
• Interact effectively with peers and leaders as part of a multi-disciplinary team
• Effective verbal and written communication skills

Nice-to-Have:

• Experience in a {Current} Good Manufacturing Practices {part of GxP} laboratory
• Understanding of various scientific software or software used in pharmaceutical or production environment
• Good Laboratory Practices (part of GxP)/Good Manufacturing Practices (also cGMP) knowledge
• Desire to develop their own technical skill set is essential