Catalent Pharma Solutions (a Blackstone Group company) is a leading Drug Development, Advanced Delivery Technology and Supply partner to the global pharmaceutical industry. A Fortune 1000 company, with over 20 locations on 5 continents, we partner with 90 out of the top 100 pharmaceutical companies and 44 of the top 50 biotech firms, as well as thousands of small innovator companies.
SUMMARY OF ESSENTIAL FUNCTIONS:
Perform microbial testing of raw materials and finished products (for Clinical, commercial, and customer products) according to current compendia methodology. Sample and test USP water and environmental samples.
SPECIFIC DUTIES, ACTIVITIES AND RESPONSIBILITIES INCLUDE BUT ARE NOT LIMITED TO:
General knowledge of compendia microbiological requirements (USP, EP, JP etc.)
Works on problems of moderate scope where analysis requires in-depth evaluation of factors. Exercises judgment within generally defined practices. Acts independently on routine tasks and under general supervision on new assignments. Demonstrates potential for technical proficiency and scientific creativity.
With supervision, carries out analytical activities in support of the manufacturing of pharmaceutical products under supervision of other scientists in the department. These activities include raw material testing, in process testing, finished product testing, sample analysis, and physical evaluation of products. Method development and/or method validation projects are within the scope of this position.
With supervision, provides GMP Testing support for quality assurance of products. This includes assisting in writing protocols and reports; ordering lab supplies • Be a qualified and effective Data Reviewer.
With supervision determines general approaches for assigned projects, then plans and executes work independently with minimal supervision.
Be proficient in Quality Systems such as Trackwise and able to execute steps in laboratory investigations.
Provides training, instruction and guidance to junior level scientists.
Perform environmental sampling and testing
Write test/sampling procedures
Prepare summary reports and certificates
Perform microbial sampling /testing activities within scheduled timelines.
Maintain notebooks and files compliant with current GMPs and SOPs.
Capable of making decisions as related to testing/test results.
Responsible for monitoring work schedules and maintaining target dates for completion.
May oversee lab personnel on projects
Comply with Health, Safety, and Environmental responsibilities for the position.
Other tasks as assigned.
MS/BS in Microbiology Experience: 3 (MS)
5 years microbial testing experience in the pharmaceutical industry.
Working knowledge and application of scientific principles and techniques.
Experience with Windows 98, Microsoft Word, and Excel computer programs.
Strong background in Microbial limits testing, Environmental Monitoring, and Identification of Microorganisms
Mathematical and reasoning ability
Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
Ability to work effectively under pressure to meet deadlines. Be accessible to laboratory and pilot plant area(s) and office staff and to use required office equipment. Specific vision requirements include reading of written documents and use of computer monitor screen frequently. Individual may be required to lift 10-15 pounds.
Individual’s primary workstation is located in the laboratory area, where the noise level is low. Employee will be present on the manufacturing floor where the noise level is low to moderate.
Catalyst + talent = Catalent. At least, that's the brand Catalent Pharma Solutions is using to try to ensure its customers' success. The...