Process Development - Purification - SENIOR Scientist As a Senior Scientist, you will help develop scaleable downstream purification processes for clients as well as support GLP projects like resin lifetime and viral clearance studies. Responsibilities include small-scale operations like buffer preparation, filtration, chromatography, viral filtration, viral inactivation, ultrafiltration/diafiltration, and data analysis. In addition, you will need to manage tasks as part of a larger project or initiative, author documents & reports, and review documents for technical content & clarity. BA/BS in Biological Science, Chemical Engineering or related discipline with at least 8 years or more experience in biopharmaceutical industry or equivalent training and/or experience is required. Process Development experience with protein purification and virus removal methods is required. A strong background in protein analytical techniques (e.g. SDS-PAGE, SEC-HPLC, ELISA, IEF, etc.) is also required. Experience with scale-up of purification processes, technology transfer of purification processes, protein conjugation and cGMP guidelines is a plus. Candidates with protein chemistry training especially with recombinant proteins. Candidates with protein chemistry training especially with recombinant proteins via mammalian expression system are highly desirable. Apply to contact information above or e-mail directly to:
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QC / ENVIRONMENTAL MONITORING - MICROBIOLOGIST Our Testing Department seeks a Microbiologist to work with our QC / Environmental Monitoring group. Your responsibilities will include sampling and testing classified air, surfaces, water, steam, gases, and personnel for routine monitoring and in support of validation. You will also complete batch records and other required documentation and perform laboratory maintenance and other duties according to regulatory guidelines. Bachelor’s degree with major in Microbiology or Biology or equivalent training and/or experience. Knowledge of microbiology, proteins and experience working with large molecules in the laboratory is preferred. Experience working in an FDA regulated industry is a plus. Apply to contact information above or e-mail directly to:
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TESTING - VIROLOGY - RESEARCH ASSISTANT Our Testing Department seeks a Research Assistant to work in our Virology lab. You will work with numerous cell lines and viruses and perform viral assays in a GLP/cGMP testing laboratory. Qualified candidates will have a Bachelor’s degree with a major in the Biological Sciences or Science related major or equivalent training and/or experience. Experience in cell culture is required. Experience in virology and GLP and/or cGMP guidelines is preferred. Apply to contact information above or e-mail directly to:
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Process Development - CELL CULTURE - DEVELOPMENT SCIENTIST IIAs a Development Scientist II, you will perform Cell Culture Process Development (PD) activities as part of a project team with a focus on developing methods and processes for the production of biopharmaceuticals including monoclonal antibodies and therapeutic proteins in bioreactors utilizing cell culture technology. You will assist in planning and leading projects within the Upstream Cell Culture group. Responsibilities include small-scale bioreactor operation (3L - 15L), working in aseptic conditions, cell culture, running daily metabolite assays, media preparation and data reporting. BA/BS in Biological Science, Chemical Engineering or related discipline and 5 years or more relevant experience or equivalent training and/or experience. Experience in small-scale bioreactor operation (3L - 15L), media formulation and feeding strategy studies, maintaining cell cultures (static and shake flask) and monitoring cell growth is required. Experience with scale-up and optimization for production with larger scale bioreactors is preferred.A pply to contact information above or e-mail directly to:
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preferred. Facilities - Metrology - Calibration Technician As a Calibration Technician in our Metrology, you will be responsible for providing Calibration services during start-up, commissioning, validation and capital improvements of a state-of-the-art, multi-product contract manufacturing and testing facility and its operation. General responsibilities include: developing calibration and periodic maintenance operational requirements for equipment/systems to support Operations. Specific responsibilities include: monitoring and calibration of instruments, managing and scheduling the use of test equipment and standards, troubleshooting equipment/processes, maintaining an up-to-date, database of calibration status of all instrumentation and equipment, managing external contractors and writing reports. You will effectively execute Calibration operations to address compliance, customer and business needs in a timely manner and remains current regarding technical metrology requirements. You will also develop and/or modify equipment and systems to be in a compliant state and prepare validation protocols, Standard Operating Procedures (SOPs) and investigation reports. Qualified candidate will have an Associate’s degree in a technical discipline or related experience or equivalent training and/or experience. Working knowledge of a computerized calibration management system, hands-on calibration experience and familiarity with GLP / GMP guidelines preferred. Apply to contact information above or e-mail directly to:
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