PRINCIPAL SCIENTIST MICROBIOLOGY LAB

Job Responsibilities:

Written evaluation and recommendation of new methods, equipment and technology
for the Microbiology Laboratory and manufacturing areas based on a
scientifically sound approach. This evaluation must include area performance
and cycle time efficiency, cost and HOT. Provide formal presentations with
upper management to present the evaluation performed to the new method,
equipment or technology.Prepare method validation and equipment performance
qualification protocols andfinal reports. Maintain updated schedules of the
different activities associated to the method validation and equipment process
performance. Establish shortand long range plans for the timely and efficient
execution of the different validation and qualification activities. Lead the
implementation of the new Methods, Equipment and Technology. Coordinate routine
meetings with the different plant departments in order to allocate the needed
resources to complete the validations and qualifications to the expected due
dates. Prompt support to Parenteral Manufacturing operations and Micro
Laboratory o Initiate or oversee investigations, provide in depth analysis and
recommendations o Provide expert and in depth analysis to ongoing operations
Manufacturing and Laboratory so that facilities and procedures are continuously
improved. o Lead Isolator Micro qualification and requalification efforts

Job Requirements/Education:

Master or Ph.D. degree in Biology, Biotechnology, Microbiology or Industrial
Microbiology. A minimum of 5 to 7 years of experience working in a Parenteral
Pharmaceutical Industry. Strong experience in the development and validation
ofmicrobiology methods and the validation of laboratory equipment. Knowledge
andexperience is desirable in the following areas parenteral products,
environmental monitoring program, aseptic fill operations, isolators,
sanitation and sterilization process. Excellent communication skills in English
and Spanish oral and written. Must have knowledge in compendium requirements,
cGMP, GLP, FDA and EU regulations and the ability to interpret and apply them.
Working knowledge of sterility isolators preferred Working knowledge in PCs
Words, Excel, Power Point, Microsoft Project is a must

Salary will be commensurate with experience.
Bristol-Myers Squibb is an equal opportunity employer. M/F/V/D