Associate QC Scientist - Microbiology
Job Description Position Overview: Catalent hires people with a passion to make a difference to the health of millions of people globally. Your expertise, coupled with Catalent's advanced technologies and collaboration with thousands of innovative pharmaceutical, biotech and healthcare companies, will help bring life-enhancing products to the people you know and love. Your talents, ideas and passion are essential to our mission; to develop, manufacture and supply products that help people live better, healthier lives. Interested in learning more about life at Catalent? Start here 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. Position workweek is Monday-Friday (8am-5pm) and will reside at the Harmans/BWI campus. Catalent Cell & Gene Therapy hires people with a passion to make a difference. Your expertise, coupled with our advanced technologies and collaboration with innovative pharmaceutical, biotech and healthcare companies, will help bring life-enhancing products to the people you know and love. Your talents, ideas and passion are essential to our mission; to develop, manufacture and supply products that help people live better, healthier lives. 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. * Experience with viable and non-viable Environment Monitoring collection instruments. We will identify candidates based on the following: * Leads with Integrity and Respect * Delivers Results * Demonstrates Business Acumen * Fosters Collaboration and Teamwork * Champions Change * Engages and Inspires * Coaches and Develops Position Benefits: * Join a high growth and fast paced organization with a people focused culture * Global exposure, defined career path and annual performance review and feedback process * Competitive Medical, Dental, Vision and 401K 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. Catalent is committed to the health and safety of its employees, visitors and the customers and patients we serve. As a result of the global pandemic, we have modified many of our recruitment and on-boarding processes to maintain everyone's safety. The Human Resources teams will communicate all necessary safety processes and procedures throughout each stage. personal initiative. dynamic pace. meaningful work. Visit www.catalent.com/careers to explore career opportunities. Catalent is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation or gender identity. If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process. Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.