Scientist

Job Summary ( Summarize the primary purpose & key accountabilities of the job function. )

Responsible for Analytical Method development, Method Validation, Method transfer, Investigation through DMAIC approach, Regulatory support, Routine analytical and stability study support for API, Intermediates and different DP formulations with minimal/no supervision.

Provide the technical training to junior scientist, Trouble shooting, Stakeholders management.

Job Responsibilities ( Indicate the primary responsibilities critical to the job function. )

ROLE RESPONSIBILITIES

• Perform method development, validation, transfer, Investigation, regulatory support, API qualification, Characterization and reaction monitoring support under safety and quality compliance to enable Breakthroughs that change in patients life.
• Delivery of Method remediation, Investigations, Method validations, NNO assessments, Method transfer and Tech support to Network sites.
• Develop relationships with customers and stakeholders to ensure global support for changes with a wider impact for the product value stream.
• Participate in technical investigations by applying Six Sigma methodology.
• Analytical data review, eLN review, Scientific protocol, and report preparation.
• Review and understand newer technology and its implementation in the projects.
• Ensure compliance to cGMP/GSP organization s procedures and practices.
• Ensure effective safety systems are implemented on the premises.
• Target Zero safety incidents in the Laboratory and working areas.
• Review of electronic Notebook of Analytical scientist data.
• Investigation of analytical testing failures (i. e. , OOS /OOT) through DMAIC tools.
• Procurement of standards and Impurities from Vendor and verification of characterization data.
• Planning and execution of stability study Program for Development batch samples.
• Temperature Excursion /Freeze thaw studies

Qualifications/Skills: Education - Experience - Additional Requirements ( Indicate qualifications and skills that are necessary for performance of responsibilities including: education, relevant experience, licenses, certifications, and other job-related technical and managerial skills. )

MSc/M Pharm/Ph. D in Chemistry (or) Analytical Chemistry with 6 to 10 years of experience in Analytical development, Method validations, Impurity isolation & Characterization, Life cycle management, and Transferring new technologies to network sites. Experience in working in Analytical development in Drug substance and drug product background with a good knowledge of Analytical research and development is strongly preferred. Understanding of Analytical chemistry, Organic chemistry, and Hyphenated equipment.

Exposure to the fundamental of user-friendly analytical methods (All techniques) which is user friendly and good process capability from an Analytical perspective to ensure CQ Labs will release the commercial batches on time without any bottlenecks.

Familiarity with all essential analytical techniques (e. g. Wet chemistry, HPLC, GC, Mass spectroscopy, Regulatory requirements, Dissolution, FTIR, and UV/Vis).

Communication, and listening skills.

Organizational Relationships: (Provide the primary groups or key role(s) that this role will interact with as a regular part of the job responsibilities. Include any external interactions as appropriate. )

• Small Molecule Technology
• Global Technology & Engineering
• Launch Excellence
• Pfizer Manufacturing Sites
• External Supply
• Global Supply Chain
• Regulatory Sciences
• Global EHS
• Procurement
• Pharmaceutical Sciences Small Molecule
• Contract Research, Development and Manufacturing Organizations
• Academic Institutes