Catalent Pharma Solutions - Winchester, KY

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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.

Catalent Pharma Solutions is experiencing explosive growth within its Development and Analytical Solutions group and needs a bright and energetic leader to join its world-renowned Inorganic Analysis team. You will primarily be responsible for developing and validating methods for inorganic elemental content at trace levels in raw materials and finished pharmaceuticals in a fast-paced, customer-focused environment.

The Microbiologist is primarily responsible for performing complex, non-routine microbiological analysis, and therefore must be capable of recognizing the need for pathogen identification, solving microbiological system problems, and leading and completing microbial investigations related to the water system, environmental monitoring of production equipment, the air handling system, raw materials and finished goods. The work is “hands on” and maintains the microbial testing needed to support raw materials, finished goods and environmental monitoring for the facility. Specific Tasks, Duties and Responsibilities: RESPONSIBILITIES INCLUDE, BUT ARE NOT LIMITED TO: • Proficiency with aseptic technique, microbiology laboratory skills and general laboratory safety. • Perform efficient/reliable microbial testing in accordance with USP/NF/EP/JP or customer guidelines. Typical testing may include microbial water analysis, chemical water analysis, product contact surface environmental monitoring, viable/nonviable air monitoring, and raw materials and finished goods Microbial Limits Tests. • Maintain accurate written records of all testing performed. • Accurately interpret and effectively communicate microbial results and issues. • Schedule daily tasks in an organized and efficient manner. • Calibrate and maintain microbiology lab equipment. • Review, revise and/or write microbiology test methods and SOPs. • Develop proficiency in standard operating practices and test methods. • Perform peer review of microbiology testing and write up. • Prepare and perform microbiological validation protocols and summary reports. • Lead investigations involving microbiological Out of Specification results. • Assist in training Associate Microbiologists/ new Microbiologists on SOPs and test methods. • Takes personal ownership in work and takes responsibility for all elements of their assignments. • In combination with other lab personnel, be responsible for a clean and safe working environment. • Other duties as assigned. Essential Skills and Experience: Education or Equivalent: (Minimum required to perform job) Bachelors Degree in Microbiology, Biology or Chemistry (Preferred in Microbiology or Biology) Work Experience – 0 to 5 years in a Microbiology Laboratory, Clinical or Chemical Manufacturing role (including internships and co-op experience). Knowledge/Skills Requirements: (List unique knowledge skills, or problem-solving requirements) • Ability to multi-task with high efficiency. • Ability to work well under pressure and maintain efficiency. • Ability to communicate effectively. • Attention to detail. • Basic knowledge of lab safety and the ability to work safely with microorganisms. • Working knowledge of cGMP regulations. • Working knowledge of aseptic technique and microbiology principles. • General computer literacy including use of Microsoft Word and Excel. • Ability to stand/sit for long periods of time. • Accurately test on the first attempt under pressure of production details. • Experience in the pharmaceutical industry or clinical microbiology preferred. • Ability to work well as part of a team. • Assist with regulatory and customer audits when Microbiology information is required. Physical Requirements: Work Schedule: Shifts of 8 or 12 hours in duration. Essential Physical Job Tasks: • Data entry o Input of test results, trending and generation of Certificates of Analysis. • Laboratory Procedures o Safely perform testing required by position and proper use of PPE. o Knowledge of and proper use of equipment. o Safely handling microorganisms and reagents. o Regular cleaning of lab space as required. o Understanding and proper practice of dress code for manufacturing area. • Coordination with other laboratory personnel for maintaining safe environment o Assisting other personnel with lifting of all objects of greater than 20 lbs. o Maintaining clean and orderly environment for laboratory operations. o Use of autoclave and safe handling of autoclaved materials, reagents, microorganisms and other required equipment. • Coordination in a laboratory setting o Operating safely in a dynamic environment which includes mobile and fixed equipment and changing conditions while completing job tasks that range from simple to complex and/or multi-tasking. Safety Considerations: • Must wear safety glasses, or specified eye protection, in all designated areas. • Must follow any applicable plant safety requirements. • Must be fit-tested, trained and capable of wearing air purifying respirator. • Must understand and practice aseptic technique. • Must be trained in plant hazardous material procedures. • Must be able to lift up to 20 lbs. Environmental Conditions: • Working conditions will be Heating Ventilation and Air Conditioned controlled.


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Catalyst + talent = Catalent. At least, that's the brand Catalent Pharma Solutions is using to try to ensure its customers'...