Job Description

The Associate Scientist, QC will oversee the end-to-end contamination control and sterility assurance practices for Catalentxe2x80x99s aseptic production process. This position will support the following areas: Aseptic processing, cleaning and disinfection process, microbiological testing, environmental control and monitoring, compliance to regulations and standard in the subject of sterility assurance and contamination control. The Associate Scientist, QC will work both independently and with the team to perform routine and non-routine microbiological testing and microbiology laboratory maintenance functions, where necessary.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.The role:

• Ensure testing compliance meets the requirements of ISO, USP, CFT, cGMP, and GLP, in the Microbiology laboratory at all times.
• Document laboratory test results utilizing Good Documentation Practices.
• Conducts testing of utilities such as USP water, clean steam, and testing of other manufacturing environments (air, surfaces).
• Always maintain the Microlab in Audit Readiness.
• Provide accurate product, raw material, and Environmental monitoring microanalysis data
• Ensure daily or weekly maintenance of all Micro-laboratory instrumentation and media usage dates.
• Review Micro results for other Microbiologists, ensuring current results & report trends to the QC Manager.
• Perform Bacterial Endotoxin and Sterility Testing.
• Perform microbial identification via polymerase chain reaction (PCR).
• Perform growth promotion testing of microbiological media.

The candidate:

• Bachelor in a Microbiology, Molecular Biology, or related discipline with 0 xe2x80x93 2 years of experience working in a cGMP QC laboratory.
• Knowledge of cGMP, familiarity with Quality Tools such as SPC and Root Cause Analysis, USP, HACCP, and Technical writing skills.
• Test method development and validation of various bioassay and microbiological or chemical test attributes
• Demonstrate knowledge of scientific understanding of analytical and microbiological methods or chemical methods and their relation to natural processes.
• Demonstrated ability to investigate and identify causes of suspect laboratory results.
• Working knowledge of analytical and/or microbiological method design.

The anticipated salary range for this position in Maryland is $58,240 to $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 to explore career opportunities.Catalent is an Equal Opportunity Employer, including disability and veterans.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 . 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.Important Security Notice to U.S. Job Seekers:Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respondxe2x80x94 it is a fraudulent request. Please forward such requests to spam@catalent.com for us to investigate with local authorities.California Job Seekers can find our California Job Applicant Notice .

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