The objective of the role is to perform chemical synthesis of molecules, the role involves process development, process validation and transfer to production units.
JOB DESCRIPTION
(What the person needs to deliver at workplace)
Literature search and collection of MSDS.
Performing the lab experiments.
Documentation of lab experiments, experimental results and interpretation of spectral data.
Maintenance of documents like patents, literature, analytical reports.
Discussion with analytical chemists and DQA on analytical results and methods.
To account for chemical usage and availability of raw materials.
Performing the calibration of lab equipment's like weighing balance, pH meter, and driers.
Performing the lab experiments and updating to immediate supervisor.
Maintaining of lab notebook and documentation of experimental results.
Ensuring the availability of regular solvents reagents and indent to warehouse.
Management of effluent generation from lab experiments.
Round the clock follow up and monitoring the plant batches during process validation.
Perform Manual Solid Phase Peptide Synthesis of Peptides on Medium scale, commercial scale (1 to 10 g, 100 g and 1kg final product) with minimal or no supervision.
Purification of solid phase products, commercial process, CGMP activities, synthesis of impurities, reference standards and degradation impurity standards for analytical method development and validation.
Safety awareness and implementation
Strict adherence to Good Laboratory Practices and Laboratory Safety Norms.
QUALIFICATIONS/ EXPERIENCE REQUIREMENTS
Parameter
Minimum
Preferred
Education
M.Sc. (Organic Chemistry)
M.Sc. (Organic Chemistry)
Experience (in Years)
2
6
Nature of Experience
Prior work experience in R&D Department of an API manufacturing company, knowledge of Process R&D and scale up experience.
COMPETENCY REQUIREMENTS
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FUNCTIONAL
Functional Knowledge
Coupling Reagents
Documentation
GLP and safety compliances