Associate Scientist, QC Microbiology

Associate QC Scientist

Position Summary

• Shift: Monday-Friday 12am-8:30am
• 100% on-site

Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually.

This Associate QC Scientist is responsible for Environmental Monitoring sampling, analyzing, and aseptic monitoring and microbiological testing to support Phase I/II GMP manufacturing. Works in a fast-paced environmental supporting the quality control department of a CMO for manufacturing of biologic bulk drug substance, sterile finished drug product, and fill/finish.

The role:

• Perform Environmental Monitoring Cleanrooms, including sampling of viable surfaces, viable air and non-viable particulates in a Phase III/Commercial GMP Manufacturing facility.
• Conducts routine sampling and testing of Clean Utilities such as USP water (WFI) and clean steam along with conducting bioburden testing on prepared buffers/solutions, equipment cleaning samples, in-process and release drug product samples.
• Ability to isolate and sub-culture microorganisms for identification.
• Provides input on SOP revisions and may assist in the creation and editing of protocols.
• Works closely with manufacturing and QA to coordinate routine EM, changeover EM, and monitoring to support client campaigns. Effectively communicates results of own work through discussions and documentation with some input from supervisor.
• Performs Aseptic Process Simulations (media fills) and fill/finish monitoring which includes continuous monitoring of air quality, personnel aseptic technique, and environment integrity.
• Compilation and trending of Environmental Monitoring data for reporting purposes.

The candidate:

• B.S. or A.S. in a Life Sciences discipline and 0-4 years of relevant experience working in cGMP cleanrooms.
• Experience working in cGMP Quality Control – Good Manufacturing Practices (cGMP’s).
• Flexibility in following unique campaign requirements that may include off-hour and weekend work.
• Experience with Microsoft Excel and Microsoft Word. Strong exposure and attention to detail to revising SOP’s and analyzing data.
• Have the knowledge and ability to apply basic scientific and regulatory principles utilized to solve operational, as well as routine quality tasks.
• Ability to produce results in a fast-paced environment to meet client deadlines under minimal supervision.

The anticipated salary range for this position in Maryland is $58,240 - $80,080 plus an annual bonus target. The final salary offered to a successful candidate may vary, and will be dependent on several factors that may include but are not limited to: the type and length of experience within the job, type and length of experience within the industry, skillset, education, business needs, etc. Catalent is a multi-state employer, and this salary range may not reflect positions that work in other states.

Why you should join Catalent:

• Competitive medical benefits and 401K
• 152 hours PTO + 8 Paid Holidays
• Dynamic, fast-paced work environment
• Opportunity to work on Continuous Improvement Processes

Catalent offers rewarding opportunities to further your career!  Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference. 

personal initiative. dynamic pace. meaningful work.

Visit Catalent Careers to explore career opportunities.

Catalent is an Equal Opportunity Emp