HASSANE ELHASSANI

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Summary:

Bioprocess technology professional with 8-years of cGMP manufacturing experience in biologics

Proficient in upstream process unit operation and provided leadership to manufacturing associates, assistants and technicians

Expertise in training new employees to perform and verify shop-floor manufacturing process activities

Professional Experience

Fraunhofer – Center for Molecular Biotechnology, Newark, DE-19711

Fruanhofer USA Inc is a not-for -profit organization, producing plant based vaccines, monoclonal antibodies for phase I & II clinical trials.

Senior Manufacturing Associate, Upstream Process (cGMP): Feb 2009 – Jun 2017

Proficient in bioreactor Set-up, Operation, Cleaning (CIP/SIP) and validation.

Expert in harvesting mammalian cell culture and clarification techniques for large scale manufacturing (CUNO and Polish Filtration)

Expertise in cell banking production process (MCB & WCB).

Provided leadership to manufacturing associates, assistants and technicians in shop-floor

Associated with process area manager to create GMP training plans and schedules and organized new employee’s training program

Assured sterility of microbial infectious agent for large scale recombinant protein production/purification.

Experienced in process media/buffer preparation and membrane Integrity testing.

Proficient in cleaning/maintaining, validating and operating bioprocess equipment and skid.

Expertise in generating/revising/reviewing cGMP documents (BPRs, SOPs/Logbooks) as system owner.

Expert in SCADA Biocommand software to control bioreactor for process.

Initiated department audits, as well as corrective and preventative actions (CAPA).

Proficient to train new employees to perform and verify GMP manufacturing process activities

Professionally trained personnel to work in industrial environment to comply FDA regulations and quality systems.

Performed operators individual assessment to approve annual performance appraisal

Research Associate Quality Control June 2012 - April 2017

(Additional Assignment)

Proficient in environmental monitoring investigation and assay.

Expertise in analyzing sample (TOC/Bioburden) for validation.

Expert in real time analyzing bulk drug substance for purity and stability.

Expertise in analyzing USP/WFI water sample, swab from shop-floor for compliance system.

Proficient in maintaining and tracking QA/QC documents.

Proficiency with generating cGMP documents for new product analysis.

Research assistant R & D Jun 2008 – Feb 2009

Developed fermentation process for Agrobacterium.

Optimized growth condition parameters to scale-up process.

Proficient in scale up process for manufacturing.

Expertise in plant vacuum infiltration for upstream investigation.

Expert in protein extraction and clarification, sample analysis.

Proficient in analytical assay: Western blot, SDS-PAGE to quantify data.

Phillips Mushroom Farm

Laboratory Assistant Jan 2006 - Jun 2008

Responsible for culture of exotic mushrooms in fermenters.

Proficient in micro-organisms aseptic culture techniques and methods.

Skilled in fermenter and carboy set up and operation.

Developed microscopic assay to identify contamination.

Proficient to develop techniques to culture mushroom products.

Capable to prepare inoculums, testing on agar plates to initiate large scale mushroom culture.

Education

MS Biotechnology: State Academy of Nutrition Products, Moscow Russia., 6 months

in Paris France Cultivating the Saccharomyces Vini T8 (1997 -1999)

BS Biology: University Moulay Ismael, Meknes, Morocco. (Microbiology and

Biochemistry) (1993 -1997)

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