Description:The primary role of this individual is for chromatography manufacturing. The scope of this role includes manufacture of production batches for the Concentrates work center. The scope of this role may include manufacture of production batches for the Purification work center. The scope of this role includes auditing of chromatography batch records. Candidate must demonstrate the ability to understand formulation processes, work with processes and equipment, detailed written documentation of work, ability to work well with others, and compliance.This position includes the handling of all types of materials, including hazardous and DEA (Drug Enforcement Agency) controlled materials.As a Biochemist 1, will be responsible for:Manufacturing of Concentrates, Purified Antibodies, and Purified Conjugates via liquid chromatographyAuditing and GMP/GDP verification of batch records and product release responsibilitiesDetails of job tasks include:Following established manufacturing protocols to conjugate and/or isolate proteins for use in immunological assays.Buffer and chromatography column preparationMaintaining a legible and accurate batch record according to proper GMPMaking decisions and executing critical steps in the manufacturing processMaintaining an FDA/DEA compliant laboratoryProviding Quality Notification SupportExecuting temporary manufacturing deviations and pilot productsCompletion of all necessary training activitiesRequired Knowledge/Skills, Education, and ExperienceBachelor’s Degree required. (Biology, Chemistry, Engineering, or other applicable Science Degree)3-5 years chromatography work experience.Proficiency with basic lab equipment (pipettes, balances, centrifuges)Proficiency in Microsoft Office ProgramsStrong communication and organizational skillsStrong mathematical and critical thinking skillsMust have legible handwritingMust be able to safely lift 50lbsPreferred Knowledge/Skills, Education, and ExperienceExperience with AKTAsA background in manufacturing processesFamiliarity with GMP/GDP guidelinesMust Have - AdminNotes:8am - 4:3pmThis role will provide weekend coverage, Tuesday – Saturday or Sunday - Thursday with training occurring on Monday – Friday.VIVA is an equal opportunity employer. All qualified applicants have an equal opportunity for placement, and all employees have an equal opportunity to develop on the job. This means that VIVA will not discriminate against any employee or qualified applicant on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status
Description:The primary role of this individual is for chromatography manufacturing. The scope of this role includes manufacture of production batches for the Concentrates work center. The scope of this role may include manufacture of production batches for the Purification work center. The scope of this role includes auditing of chromatography batch records. Candidate must demonstrate the ability to understand formulation processes, work with processes and equipment, detailed written documentation of work, ability to work well with others, and compliance.This position includes the handling of all types of materials, including hazardous and DEA (Drug Enforcement Agency) controlled materials.As a Biochemist 1, will be responsible for:Manufacturing of Concentrates, Purified Antibodies, and Purified Conjugates via liquid chromatographyAuditing and GMP/GDP verification of batch records and product release responsibilitiesDetails of job tasks include:Following established manufacturing protocols to conjugate and/or isolate proteins for use in immunological assays.Buffer and chromatography column preparationMaintaining a legible and accurate batch record according to proper GMPMaking decisions and executing critical steps in the manufacturing processMaintaining an FDA/DEA compliant laboratoryProviding Quality Notification SupportExecuting temporary manufacturing deviations and pilot productsCompletion of all necessary training activitiesRequired Knowledge/Skills, Education, and ExperienceBachelor’s Degree required. (Biology, Chemistry, Engineering, or other applicable Science Degree)3-5 years chromatography work experience.Proficiency with basic lab equipment (pipettes, balances, centrifuges)Proficiency in Microsoft Office ProgramsStrong communication and organizational skillsStrong mathematical and critical thinking skillsMust have legible handwritingMust be able to safely lift 50lbsPreferred Knowledge/Skills, Education, and ExperienceExperience with AKTAsA background in manufacturing processesFamiliarity with GMP/GDP guidelinesMust Have - AdminNotes:8am - 4:3pm
This role will provide weekend coverage, Tuesday – Saturday or Sunday - Thursday with training occurring on Monday – Friday.
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