Senior Scientist- Cell Banking - Lancaster Laboratories - King of Prussia, PA

Senior Scientist- Cell Banking - Lancaster Laboratories - King of Prussia, PA -

Eurofins is the world chief within the meals, bio/pharmaceutical product testing. Additionally it is primary within the subject of environmental laboratory providers and one of the worldwide market leaders in agroscience, genomics, discovery pharmacology, and central laboratory providers. With over $1.5 billion in annual revenues and 17,000 staff throughout 200 websites in 36 nations, Eurofins is a number one worldwide group of laboratories offering an unparalleled vary of testing and help providers to the pharmaceutical, biopharmaceutical, meals, environmental, and shopper merchandise industries and to governments. Eurofins Lancaster Laboratories PSS is looking for a Senior Scientist: Cell Banking in King of Prussia PA. Senior Scientist: Cell Banking duties embrace, however aren’t restricted to, the next : Present first line supervision of cell bank manufacturing (onsite at shopper website or outsourced to a CMO) stability testing, and cell bank stock (storage and delivery). Might take part in operations when essential. Chargeable for coordinating the receipt of uncooked knowledge from the manufacturing batch data, reviewing and storing the info in accordance with the shopper’s procedures. Develops manufacturing schedules and makes work assignments to guarantee that assets are used effectively and that product supply targets are met. Assures that cell banking operations happen in full compliance with the FDA’s GMP laws. Chargeable for course of switch from improvement to cell banking or CMO. Chargeable for creation, assessment and approval of grasp batch data (MBR). Answerable for approving and reviewing all executed MBRs. Liable for the preparation, evaluation and approval of GMP paperwork resembling Normal Working Procedures, validation paperwork, and Materials Specs as wanted. Assures that each one batch data and associated course of documentation are precisely accomplished. Initiates investigations to deal with deviations from specified course of. Ensures LN2 freezers, shippers, and cell banking gear are maintained in a calibrated and validated state. Chargeable for cell banking stock management and reconciliation. Participates within the specification and procurement of uncooked supplies and different important manufacturing elements as wanted. Troubleshoots operational issues and supervises corrective actions. Offers operational help to the engineering employees answerable for performing validation research and manages change controls associated to Engineering and Validation actions. Writes cell bank sections of regulatory submissions as wanted. Supplies common cell banking help, together with stock management, change management procedures and pattern cargo. Participates in technical due diligence evaluations of new suppliers. The perfect candidate would possess : Thorough information of the FDA’s GMP laws and the NIH Tips for rDNA Organisms. Extremely skilled in aseptic processing methods Robust pc, scientific, and organizational expertise Wonderful communication (oral and written) and a spotlight to element Potential to work independently and as half of a workforce, self-motivation, adaptability, and a constructive angle Means to study new methods, carry out a number of duties concurrently, hold correct data, comply with directions, and adjust to firm insurance policies Primary Minimal Qualifications : Bachelor’s diploma in biology, chemistry, or different associated diploma focus, or equal instantly-associated expertise (two years of immediately associated business expertise is equal to at least one full-time yr of school in associated main) Minimal of 4 (four) years cell banking expertise Authorization to work in america indefinitely with out restriction or sponsorship Place is full-time, Monday-Friday, eight a.m.-5 p.m., with extra time as wanted. Candidates presently dwelling inside a commutable distance of King of Prussia Pennsylvania are inspired to use. As a Eurofins Lancaster Labs worker, you’ll develop into half of an organization that has acquired nationwide recognition as a terrific place to work. We provide wonderful full-time advantages together with complete medical protection, life and incapacity insurance, 401(okay) with firm match, paid holidays and trip, private days, and dental and imaginative and prescient choices. To study extra about Eurofins Lancaster Laboratories, please discover our web site www.lancasterlabs.com . Eurofins is a M/F, Disabled, and Veteran Equal Employment Alternative and Affirmative Motion employer.

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