Research Chemist

We have an exiting opportunity in our Chemical Process Research laboratory department based at Govandi (Navi Mumbai)

Job Objectives:

To perform chemical research activities to optimize development process (of API); while adhering to regulatory norms and established SOPs

Role & responsibilities

Process development and validation

• Assist the group leader in conducting literature review by collating relevant documents and providing preliminary analysis/views
• Conduct, observe and document chemical procedures by following methodology prescribed by Group Leader to assess the workability of the proposed RoS
• Check and ensure availability of reagents and other raw materials/equipment for testing
• Share CAS numbers of required chemicals with R&D sourcing team
• Check materials upon receipt and raise relevant issues with quality
• Raise PR for purchase
• Maintain log of all lab activity and lab experiments in the lab notebook on a regular basis
• Provide samples to external testing locations and ARL for testing. Collect and file reports of analysis 
• Prepare reference standards chemicals

Process Transfer as per cGMP

• Plan and ensure timely  transfer to kilo-lab for pilot testing by conducting and documenting relevant lab experiments 
• Jointly monitor production process at kilo-lab alongside TT team
• Plan and ensure timely  transfer to plant by conducting and documenting relevant lab experiments 
• Raise safety concerns to be evaluated as part of HAZOP study
• Respond to queries raised by plant during production

Vendor Development and management

• Check documents (CoA, etc.) and samples received from vendor
• Submit samples to ARL for analytical testing pre and post the use test
• Conduct experiments for vendor qualification
• Conduct a use-test for samples
• Support production of select intermediaries and raw materials at third part locations

Regulatory and compliance

• Adhere to regulatory, cGMP, SOPs and safety guidelines for all processes 
• Ensure timely closure of regulatory queries by conducting and documenting specified experiments in the lab
• Calibrate all instruments as scheduled 
• Ensure scheduled maintenance by coordinating with relevant vendors
• Ensure data integrity in all respects

Stores (material) management

• Support management of chemical stores
• Transfer/store chemicals per set norms
• Maintain log of materials
• Ensure materials sent to lab as per need

IP generation and patent filing

• Conduct and document  IP-related experimentation and lab work

Learning and improvement

• Attend all mandatory trainings 
• Take initiatives for self-development and update self on recent developments in own area of work

Preferred candidate profile

• Candidate should be M.sc post Graduate.
• Candidature should have minimum 2 years of experience in API Process Development

Additional details

• We are a 6 Days working company (1st, 3rd & 5th Saturday working and 2nd & 4th Saturday holidays) 
• Designation can be decided post interview.