Eisai Pharma invites Research Scientist / Senior Research Scientist (Engineering research)

Eisai Co., Ltd. based in Tokyo, Japan is a research-based human health care (hhc) company that discovers, develops and markets products throughout the world. Eisai's corporate human health care (hhc) mission is to give first thought to patients and their families, and to increase the benefits that health care provides.

Post: Research Scientist / Senior research scientist (Engineering research)

Job Description:
Responsibilities:
Expected to work / provide support for following activities pertaining to efficient, safe & quality compliant API Scale Up in kilo lab and Pilot plant operations Responsible for scaling up new products from lab scale to kilo lab followed by bulk production as per cGMP and production management.
Process stabilization in kilo lab and pilot plant, product yield and quality improvement during scale up.
Familiar with different type of reactions and unit operations and reaction calorimetric data. Should have a capability to handle process safety & optimization equipments like Reaction calorimeter, Crystallization probes like FBRM, gas evaluation kits and parallel synthesizers etc.,
Should have knowledge of Reaction characterization and Scale up studies in a lab environment.
Through knowledge in Calorimetric principles, Temperature control modes, Physical Chemical characteristics, Statistical Design and data management Calculation of consumption coefficients of raw materials for drugs.
Preparation of technical specification, minimum stock list and checklist for equipment / system to initiate the production at pilot plant.
Manufacturing Scale up data generation Compliance Process economics Essential Duties & Responsibilities Understanding Process, Safety, Quality and Operations Requirements.
Preparation and review of GMP and admin documents like batch record, cleaning protocols, campaign summary report, SOPs, monthly report etc
Support in planning and scheduling of chemical campaigns Supervising and executing chemical batches Inter and intra division coordination with stakeholders (CRD, ARD, QA, Engineering EHS, vendors)
Coordinating with QA, QC, maintenance & ware house departments for process validations, cleaning validations, stability studies, in-process & finished product samplings, preventive and breakdown maintenance.
Modification of equipment, process flow, working practices, consumables, power etc for controlling & reducing conversion cost per unit produced.
Knowledge about preparing BMR’s, SOP’s and production planning.
Should have knowledge about commissioning of glass reactors, pilot plant reactors.
Knowledge of Process flow diagrams (PFD’s), Piping and instrumentation diagrams (PID’s) and CAPEX.
Knowledge of cGMP, ISO, USFDA, MHRA standards and clean room standards of all API’s.
Should perform mass balance and energy balance calculations, pump calculations, utility calculations, equipment sizing etc.,
Knowledge of HOZAP study. Responsible for maintaining and comply with the EHS standards and procedures in the plant promptly correct any unsafe conditions or deviations on observation.
Production planning and inventory control. Indenting materials & equipments and follow up with supply chain department, checking of material against purchase order.
Supervise, motivate, provide training and develop team to contribute effectively towards project targets.

Candidate Profile:
Should possess B.Tech/ B.E. - Any Specialization, Diploma - Any Specialization, Bachelors/post graduate degree in Chemical engineering.
Should have a minimum 4-7 years of experience in scale up at kilo lab, pilot plant & technology transfer Should have a capability to handle process safety & optimization equipments like Reaction calorimeter, Crystallization probes like FBRM, gas evaluation kits and parallel synthesizers etc.

Additional Information:
Exp: 4-7 years
Location: Visakhapatnam
Education: B.Tech, B.E.
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: R&D