Ronald Preibis has over 17 years of experience in the biotech field, including extensive experience in all aspects of cell culture and purification. He has worked in manufacturing roles at several biotech companies, leading teams and supervising processes. His experience includes process development, cGMP manufacturing, analytical testing, documentation, and ensuring regulatory compliance. He is pursuing additional education in life sciences and biomedical laboratory sciences.

1. RONALD PREIBIS
334 Sumner Street,Norwood, Massachusetts 02062 | H: 781-769-4943 | C: 781-718-6134 | rdpreibis@yahoo.com
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 Cell culture experience at a small
leader experience and large scale
Pilot plant and kilo lab Chromatography, smalland large
experience scale purification
Performing Experience in protein analytics
upstream/downstream supporting Ab discovery
production activities in a GMP High-performance liquid
environment chromatography (HPLC)
Process development analytical techniques
Extensive knowledge of FDA Bioreactor: CIP, SIP, perfusion
regulatory and compliance techniques and setup
guidelines
EDUCATION
Associate of Applied Science: Life Sciences
MassBay Community College － Wellesley, MA
Degree expected 2017.
Biomedical Laboratory and Clinical Sciences
Boston University － Boston, MA
Completed 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 to09/2015 SENIOR MANUFACTURING ASSOCIATE
AMGEN － 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 to01/2014 PROCESS TECHNICIAN

2. PFIZER 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 to06/2012 MANUFACTURING SPECIALIST
GENZYME 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 to03/2011 MANUFACTURING ASSOCIATE II
SANOFI 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.).

3. 09/2007
01/2006
08/2004
04/1998
Trained coworkers and lead teams for downstream process.
10/2008 LABORATORY ANALYST
BLUE 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.
08/2007 MANUFACTURING ASSOCIATE II
XCELLEREX, 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.
12/2005 LAB TECHNICIAN, PURIFICATION DEVELOPMENT
GENZYME 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.
02/2004 CHEMICAL TECHNICIAN
SEPRACOR, 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.
to
to
to
to

4. Prepared chemicalshipments (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 chemicaland generallab 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