Sanofi Assistant Manager - PRD, Process
Development
Providing
synthetic organic chemistry expertize for smooth manufacturing of APIs
and DMF compilation support to the
customer, ensuring compliance to
regulatory, group directives, quality requirements, safety standards and
effective utilization of resources, guiding a team of subordinates to fulfill
the organization’s objective.
Education / Experience
M.SC OR PH.D. IN ORGANIC CHEMISTRY
Experience: Experience: 1-4 years for
Ph.D ; 5 -8 yrs for M. Sc
Technical skills & Competencies /
Language
Knowledge of modern organic Chemistry
Knowledge of performing synthetic
experiments.
Application of varied analytical methods.
Troubleshooting
Knowledge of design of experiments
(DOEs).
Knowledge of Quality by Design (QbD).
Key responsibilities:
Process development:
Execute experiments in laboratories for
developing cost-effective processes of APIs
Isolation, Purification and characterization
of APIs/impurities
Facilitate Technology transfers
Obtaining statutory licenses for R&D
and manufacturing of APIs
Providing data for DMF compilation
cGMP:
Compliance to current GMP guidelines.
Compliance to local and international
norms (Quality/HSE)
Regulatory compliance
Regular Pharmacopoeia and regulatory
requirement review
Training of self and subordinates on
quality and HSE systems.
Instrumentation:
Knowledge of ELN for recording lab
experiments
Knowledge of NMR, Mass, HPLC, GC, UV,
FITR, DSC, etc for analysis
Awareness on data integrity aspects.
Other
Complying to HSE Requirements
Identifying and correcting unsafe
conditions or behavior's and promptly reporting other potentially hazardous
situations.
Carrying out any other assignments or
projects as per the instruction of the Dept. Head to meet with the
organizational objectives and priorities.
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