Opportunity for Principal Scientist – Analytical Development (API) in Eisai Pharma - alp consulting

Eisai Inc. is a U.S. pharmaceutical subsidiary of Tokyo-based Eisai Co., Ltd., a research-based human health care (hhc) company that discovers, develops and markets products throughout the world. Established in 1995, Eisai Inc. began marketing its first product in the United States in 1997 and has rapidly grown to become an integrated pharmaceutical business with sales of approximately $3.9 billion in fiscal year 2009 (year ending March 31, 2010).

Post: Principal Scientist – Analytical Development (API)

Job Description:

Plan and organize for timely installation of analytical equipments in R&D (API)
Preparation of Standard Operating Procedures (SOPs) for all the equipments
Control and provide the documentation requirements such as Note books, log books
Conducting the training and qualifying the each scientist in the department
Plan and conduct the timely calibrations of each instruments as per written procedures
Analytical Method Development, validation of those methods for Active Pharmaceutical Ingredients (API) and Intermediates
Perform planned day to day activities
Providing the analytical support to the synthetic R&D department in terms of timely analysis of samples and sharing the results with synthetic R&D
Preparation and execution of validation protocols
Train and plan the work in day to day activities for trainees
Ensure the compliance with the regulatory requirements
Transferring the validated methods for the commercial production
Preparation of Standard test procedures and specifications
Investigation into Out Of Specifications results and try to find out the probable reasons
Follow the Good Laboratory Practices and maintain the Good Manufacturing conditions in the laboratory
Maintain the cordial relationship within the department and with the customer departments
Ensure the 100% utilization of the instruments
Plan and perform the preventive maintenance of all the instruments to minimize the down time for each instrument
Order and procure the reference standards
Plan and prepare the working standards
Procure and maintain the spare parts for the analytical equipments
Plan and procure the consumable items like columns, solvents, reagents, and stationary
Perform the wet chemical analysis with a good analytical hand to produce the good results
Knowledge to understand the audits to help in preparing for the audits by different agencies like USFDA, MHRA, TGA and ANVISA
Understand the different pharmacopoeias requirements and develop and validate the analytical methods as per the pharmacopoeias

Candidate Profile:
M.Sc. in organic/analytical chemistry with good academic track record with 6-9 years of experience in reputed pharma companies Hands in experience to handle the analytical equipments such as HPLC, GC, NMR, UV-Vis spectrophotometer and IR
Knowledge to understand the regulatory requirements with sound scientific knowledge and with good documentation skills

Enthusiastic and dynamic, capable of working individually and also in a team Ability to manage the situations to work hard Good communication skills.

Additional Information:
Exp: 6-9 years
Location: Visakhapatnam
Education: M.Sc
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: R&D