Catalent
Scientist, QC
The Scientist, QC will oversee the end-to-end contamination control and sterility assurance practices for Catalent's 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 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. Shift: Friday-Monday, Thursday-Sunday, or Saturday-Tuesday from 8:00AM to 6:30PM. The Role
Ensure testing compliance meets the requirements of ISO, USP, CFT, cGMP, and GLP, in the Micro-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 Be the SME for all Micro-laboratory instrumentation Review Micro results for other Microbiologists, ensuring current results & report trends to the QC Manager. Communicate effectively with QC peers, cross-functional peers and management. Assist in troubleshooting and solving problems that may come up in the day to day operation of the department. The Candidate
Bachelor in a Microbiology, Molecular Biology, or related discipline with 2
4 years of experience working in a cGMP QC laboratory. Masters' in a Microbiology, Molecular Biology, or related discipline with 0
2 years of experience working in a cGMP QC laboratory. Experience working in cGMP Quality Control Experience in cGMP environment and experience 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 strong scientific understanding of analytical and microbiological methods or chemical methods and their relation to natural processes. The anticipated salary range for this position in Maryland is $74,080 to $101,860 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. 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 to DisabilityAccommodations@catalent.com. 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. 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 respond 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
HERE .
The Scientist, QC will oversee the end-to-end contamination control and sterility assurance practices for Catalent's 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 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. Shift: Friday-Monday, Thursday-Sunday, or Saturday-Tuesday from 8:00AM to 6:30PM. The Role
Ensure testing compliance meets the requirements of ISO, USP, CFT, cGMP, and GLP, in the Micro-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 Be the SME for all Micro-laboratory instrumentation Review Micro results for other Microbiologists, ensuring current results & report trends to the QC Manager. Communicate effectively with QC peers, cross-functional peers and management. Assist in troubleshooting and solving problems that may come up in the day to day operation of the department. The Candidate
Bachelor in a Microbiology, Molecular Biology, or related discipline with 2
4 years of experience working in a cGMP QC laboratory. Masters' in a Microbiology, Molecular Biology, or related discipline with 0
2 years of experience working in a cGMP QC laboratory. Experience working in cGMP Quality Control Experience in cGMP environment and experience 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 strong scientific understanding of analytical and microbiological methods or chemical methods and their relation to natural processes. The anticipated salary range for this position in Maryland is $74,080 to $101,860 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. 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 to DisabilityAccommodations@catalent.com. 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. 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 respond 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
HERE .