Senior Associate scientist

Department Name

AT-GTEL, Chennai

Job Title

Senior Associate Scientist (Chem Analytical)

Global Job levels

Job Family Group: Research and Development
Job Family: 093- Chemistry-Analytical
Job Category: Research
Job Level: R02 - Senior Associate Scientist
Job Code: 602689
Management Level: J050

Reports to

Group Lead

Location(s)

GTEL, IITM-RP.

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

Responsible for Analytical Method development, Method Validation, Method transfer, Investigation, Regulatory support, Routine analytical and stability study support for API, Intermediates and different DP formulations.

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

ROLE RESPONSIBILITIES

• Responsible to Perform all activities as per GxP
• He should adhere both quality and safety compliance according to organizational policies/procedures and regulatory guidance
• Should be able to perform trouble shooting of analytical challenges which includes method and machine.
• Responsible for development analytical methods and analytical method validation by UPLC, HPLC, GC, Dissolution for API, DP, Intermediate and Raw materials.
• Support the analytical activities of lab trial batches, feasibility batches, lab scale batches, stability batches, stability studies as per plan.
• Perform assessments of existing data packages, feasibilities and concluded remediation.
• Ensure technical output is compliant with all Global Training Curriculum for the Instrument operations, material handling and Certifications related to Quality Operations, Manufacturing and EHS.
• Work with the Quality Assurance and other cross functional teams to facilitate the consistent, disciplined execution of the LIR\ER\CAPA quality system ensuring the completeness and comprehensiveness of the assigned task.
• Ensures Compliances to local and corporate procedures and ensures all data packages are audit ready and transferable.

Coordinate with cross functional teams to ensure timely execution and resolution of all Deliverable versus target milestones

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. )

Requirements for all Global Job Levels

PREFERRED QUALIFICATIONS

• M. Sc. in Chemistry/M. Pharm

PREFERRED YEARS OF EXPERIENCE

• 3 to 6 years of Experience

TYPE OF EXPERIENCE

• Experience in Analytical Research and Development, possesses knowledge of oral solid dosage forms, liquids, semisolids, and API. Understand regulatory expectations and possess exceptional expertise in data interpretation and scientific outputs.
• Hands on experience in handling HPLC, Dissolution, UV, GC and Wet Chemistry.

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

Not Applicable.

Supervision

Not Applicable.

Work Location Assignment: On Premise

Research and Development

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