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Experienced Chief Operating Officer/CMC Head with a demonstrated history of working in the biotechnology industry. Several years of experience working with Biologics/CMC related activities/Process Development/Manufacturing/CMO-Project Management. Helped in licensing products to a Biotech company.
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Cmc ConsultantRaj Sachdev Cmc Bio Consultanting May 2019 - Aug 2023
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Chief Operating Officer & Cmc HeadImmungene Jun 2008 - Apr 2019Co Founded ImmunGene Inc. to develop and produce fusion antibody drug molecules related to Onco-Immunology. Managed ImmunGene Inc. as COO and CMC Head. Managed CMOs and CROs for Process Development (cell line development, cell culture, purification, formulation, assay development and qualification, etc.), and for manufacturing of Tox and GMP runs, scale-up, stability program, data analysis and filling of drug product. Manged IND writing and submission of CMC to FDA. Collaborated with quality and regulatory for audits, and in managing deviations, OOSs and CAPAs.
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Senior Director, Manufacturing Technical ServicesShire Hgt Mar 2006 - Apr 2007Established a Manufacturing Technical Support group, Lead Technology Transfer efforts/team, Supported PD for scale up and yield improvement, managed a CMO project.
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Manager Technical OperationsBaxter Bioscience 1999 - 2006Deerfield, Illinois, UsEstablished and lead the Technical Operations Group involved with yield improvement, and technical support including deviation management for Cell Culture, Purification, Formulation, Lyophilization and Analytical related unit operations. Improved yield in formulation that saved company several millions of dollars every year. Lead Technology Transfer Team for process transfer from the Baxter's Switzerland plant to Thousand Oaks. This project was stopped after while. Designed and established a process development facility and an analytical laboratory. -
Associate Director, Process DevelopmentAmgen Dec 1984 - Jul 1999Thousand Oaks, Ca, UsEstablished and lead a Fermentation Process Development Group. Lead several projects, transfer processes from Process Development to Clinical and Commercial Manufacturing, improved yield for several products using yeast, E.coli and mammalian expression systems and scaled up several processes. Provided technical support to Manufacturing. Collaborated with QC, QA, Regulatory Affairs, and Validation groups on various projects. Helped Design a commercial manufacturing facility. Helped design and setting up a process development facility.
Raj Sachdev Skills
Raj Sachdev Education Details
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Drexel University, PhiladelphiaBiochemical/Enzyme Engineering -
Harcourt Butler Technological Institute, Kanpur, IndiaBiochemical Engineering -
Dtu - Technical University Of DenmarkBiochemical Engineering -
Indian Institute Of Technology, DelhiBiochemical Engineering -
Indian Institute Of Technology, DelhiBiochemical Engineering
Frequently Asked Questions about Raj Sachdev
What is Raj Sachdev's role at the current company?
Raj Sachdev's current role is CMC Consultant.
What is Raj Sachdev's email address?
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What is Raj Sachdev's direct phone number?
Raj Sachdev's direct phone number is +180540*****
What schools did Raj Sachdev attend?
Raj Sachdev attended Drexel University, Philadelphia, Harcourt Butler Technological Institute, Kanpur, India, Dtu - Technical University Of Denmark, Indian Institute Of Technology, Delhi, Indian Institute Of Technology, Delhi.
What are some of Raj Sachdev's interests?
Raj Sachdev has interest in Exercise, Sweepstakes, Home Improvement, Reading, Gourmet Cooking, Sports, Watching Auto Racing, Golf, Home Decoration, Watching Sports.
What skills is Raj Sachdev known for?
Raj Sachdev has skills like Technology Transfer, Gmp, Validation, Biotechnology, Biopharmaceuticals, Cell Culture, Purification, Fda, Antibodies, Quality System, Quality Assurance, Regulatory Affairs.
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