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SENIOR MANUFACTURING ASSOCIATE Resume Example

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SENIOR MANUFACTURING ASSOCIATE
Professional Overview
Talented professional with more than 17 years of experience in the biotech field. Extensive experience in manufacturing, particularly all aspects of cell culture through purification. Proven performance in process development. Strong familiarity with cGMP practices. Extensive experience writing deviation reports and working with QA issues.
Core Qualifications
  • Supervisory experience and team leader experience
  • Pilot plant and kilo lab experience
  • Performing upstream/downstream production activities in a GMP environment
  • Process development
  • Extensive knowledge of FDA regulatory and compliance guidelines
  • Cell culture experience at a small and large scale
  • Chromatography, small and large scale purification
  • Experience in protein analytics supporting Ab discovery
  • High-performance liquid chromatography (HPLC) analytical techniques
  • Bioreactor: CIP, SIP, perfusion techniques and setup
Education
Associate of Applied Science: Life SciencesMassBay Community College － Wellesley, MADegree expected 2017.
Biomedical Laboratory and Clinical SciencesBoston University － Boston, MACompleted courses in protein purification and analysis, biochemistry I and II, organic chemistry, immunology, toxicology, forensic toxicology, medical terminology, pharmacology, biostatistics, molecular biology, regulatory and compliance issues.
Experience
07/2014 to 09/2015
SENIOR MANUFACTURING ASSOCIATEAMGEN － Woburn, MA
  • Worked with process development on priority projects.
  • Performed cell culture passages.
  • Performed purification processes, UF/DF and chromatography.
  • Performed media and buffer preparation, and other support services.
  • Revised cGMP documentation.
  • Performed manufacturing review of batch records.
  • Wrote and edited SOPs and batch records.
01/2013 to 01/2014
PROCESS TECHNICIANPFIZER INC － Andover, MA
  • Worked in highly integrated and fast-paced interdisciplinary team on process scale up activities, process troubleshooting, and cGMP manufacture of clinical and commercial drug substance.
  • Executed process operations according to SOPs such as media/buffer preparation, bioreactor set-up to purification process operations (chromatography, TFF, final filtration).
  • Played key role in troubleshooting process disturbances, identifying resolutions, and implementing corrective and preventive measures.
  • Developed and implemented process improvements.
  • Participated in timely investigations of unexpected data and trends.
  • Performed real-time assessment of process performance.
  • Performed inventorying, tracking, maintenance scheduling, and troubleshooting of mechanical equipment.
  • Set up and evaluated unit operations (daily and long-term).
  • Created and maintained job related documentation.
  • Played key role in driving continuous improvement and innovation initiatives.
12/2011 to 06/2012
MANUFACTURING SPECIALISTGENZYME CORPORATION － Allston, MA
  • Played key role in ongoing compliance and continuous improvement of all aspects of compliance within the manufacturing area and process.
  • Investigated deviations to procedures and specifications using expert knowledge of manufacturing process.
  • Drove investigation process to successful resolution through close collaboration with manufacturing and quality teams.
  • Determined root causes of problems, and proposed and implemented effective corrective and preventive actions (CAPAs) to eliminate root causes.
  • Created and presented trending and metrics reports on deviations and corrective actions.
  • Assisted with the Document Change Request (DCR) process for all process-related SOPs and production records, ensuring accuracy and consistency.
  • Authored complex, explicit documentation for new and current procedures.
10/2008 to 03/2011
MANUFACTURING ASSOCIATE IISANOFI PASTEUR BIOLOGICS － Canton, MA
  • Performed upstream/downstream production activities in a GMP environment.
  • Performed bacterial and mammalian cell culture.
  • Performed purification processes.
  • Performed media and buffer preparation, and support services.
  • Revised cGMP documentation.
  • Assisted in pilot plant operations.
  • Documented production activities according to cGMP regulations.
  • Assisted in production-related activities (lab cleaning, changeover, CIP, SIP, etc.).
  • Trained coworkers and lead teams for downstream process.
09/2007 to 10/2008
LABORATORY ANALYSTBLUE STREAM LABORATORIES, INC － Cambridge, MA
  • Tested samples from various biopharma companies per client's request.
  • Performed protein sequencing of small peptides using PVDF membranes.
  • Prepared SDS-PAGE and IEF gels for scanning and analysis.
  • Prepared ELISA assays.
  • Performed HPLC.
  • Ordered lab supplies and chemicals.
  • Purchased and maintained equipment.
01/2006 to 08/2007
MANUFACTURING ASSOCIATE IIXCELLEREX, INC － Marlborough, MA
  • Performed protein purification, column packing, UF/DF, set up/cleaning column qualifications.
  • Packed, qualified, and ran chromatography columns according to SOPs and batch records.
  • Performed cell culture through purification and final bottling of bulk substance using cGMPs.
  • Formulated and prepared buffers/solutions.
  • Set up and maintained all necessary equipment.
  • Worked with pilot plant on current short-term contracts and with process development to improve processes.
  • Wrote and edited SOPs and cGMP production records.
  • Worked with ATKA chromatography system in pilot plant.
  • Trained coworkers in purification techniques and equipment set up, maintenance.
  • Acted as team leader in purification in pilot plant and GMP suite.
08/2004 to 12/2005
LAB TECHNICIAN, PURIFICATION DEVELOPMENTGENZYME CORPORATION － Framingham, MA
  • Designed experiments to increase the process yield for downstream purification.
  • Set up and ran the ATKA chromatography system for process development experiments.
  • Prepared buffers and solutions.
  • Ordered lab supplies, equipment, and chemicals.
  • Performed equipment calibration and general lab maintenance.
  • Maintained stockroom for general lab supplies and chemicals.
04/1998 to 02/2004
CHEMICAL TECHNICIANSEPRACOR, INC. R&D － Marlborough, MA
  • Synthesized potential drug products for onsite and offsite testing in kilo lab.
  • Studied large-scale organic chemistry scale-up procedures.
  • Supported chemical inventory management software (physical check and data entry Managed equipment maintenance program (database updates, on-site repair, and coordination of off-site repair).
  • Specified and obtained new equipment to support R&D operations.
  • Performed equipment setup, modification, storage and repair.
  • Prepared chemical shipments (packaging, paperwork, and inventory reconciliation).
  • Disposed of hazardous waste and maintained hazardous waste disposal areas.
  • Maintained general-use safety equipment.
  • Maintained chemical and equipment stockrooms.
  • Ordered chemical and general lab supplies.
Skills
  • Investigating and documenting GMP drug manufacturing deviations in a formal report in accordance with the FDA
  • Writing and editing SOP and batch records for use in GMP manufacturing suites
  • Gel electrophoresis: IEF, SDS-PAGE, gel scanning and analysis
  • Working knowledge of ATKA chromatography system
  • Enzyme-linked immunosorbent assay (ELISA)
  • Preparation of buffers, solutions and media
  • Small peptide protein sequencing
  • Experience using Track wise
  • Experience with LIMS and SAP software
  • Lab equipment maintenance, apparatus assembly and repairs
  • Hazardous waste management and disposal

Gel electrophoresis: IEF, SDS-PAGE, gel scanning and analysis
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Resume Overview

Companies Worked For:

  • AMGEN
  • PFIZER INC
  • GENZYME CORPORATION
  • SANOFI PASTEUR BIOLOGICS
  • BLUE STREAM LABORATORIES, INC
  • XCELLEREX, INC
  • SEPRACOR, INC. R&D

School Attended

  • MassBay Community College
  • Boston University

Job Titles Held:

  • SENIOR MANUFACTURING ASSOCIATE
  • PROCESS TECHNICIAN
  • MANUFACTURING SPECIALIST
  • MANUFACTURING ASSOCIATE II
  • LABORATORY ANALYST
  • LAB TECHNICIAN, PURIFICATION DEVELOPMENT
  • CHEMICAL TECHNICIAN

Degrees

  • Associate of Applied Science : Life Sciences
    Biomedical Laboratory and Clinical Sciences

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