Strong business acumen essential to properly manage shifting priorities in a fast-paced manufacturing environment. Job entails translation of business needs into prioritization of projects and workload to safeguard supply chain continuity. Leads productivity projects and collaborates with TechOps on technical troubleshooting, root cause investigation, and corrective action implementations.Requires basic theoretical and practical understanding of antibodies and their application to Immunochemistry.Functions and responsibilities include but not limited toReports to Manager responsible for Hybridoma and recombinant monoclonal antibodies manufacturing and qualification of antibodies, collaborating on all aspects of supply chain compliance.Drives qualification and optimization of hybridoma and recombinant cell line to produce monoclonal antibodies using state of the art Single Use Bioreactor technology, shaker flasks, and roller bottles.Creates required SOPs to clearly define (standard work), step-by-step, optimization of cell culture expression and qualification of monoclonal antibodies. This includes clear description of design of experiments (DOE), data interpretation and application.Proactively shares information by establishing data review at the various gates of the production and qualification of cell line to produce monoclonal antibodies:Lead troubleshooting activities on commercial and new product. This includes but is not limited to batch record review, lot tracing, raw material evaluation, design, and execution of experiments.Lead simple to complex process change projects, including demonstrating feasibility, developing validation protocol, executing proper qualifications, and driving necessary changes (equipment, process, test method, procedure, training, etc.)Lead the product change using change management processesCollaborating in cross functional and cross site teamsCoaching and mentoring junior membersProcess improvements using HPS methodologies, SPS, VSMImplementing changeSkillsUnderstand general laboratory techniques such as aseptic techniques, mixing, filtration, etc.Familiar with Single Use Bioreactor technology and cell culture process optimizationKnow how to safely handle chemicals and biochemicals.Trained on good laboratory practices, good documentation practices.Strong written and verbal communicationLeadershipCoachingInterpersonal communicationProblem solving competencyDecision MakingInfluence without authorityNegotiationIntegrityEmpathyRequirements:Degree:MS or Ph.D. – Mechanical Engineering, Industrial Engineering, Chemical Engineering, Biomedical Engineering, Electrical Engineering, Biochemistry, Biology, Chemistry, or related sciencesNote :Onsite8am - 4:30pmVIVA 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.
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