cGMP Development / Manufacturing Manager

ROBERT M. SUYDAM

410-***-**** ? ab2l5h@r.postjobfree.com ? http://www.linkedin.com/pub/robert-

suydam/8/1a8/6b8

SUMMARY

Biotech professional with extensive downstream process expertise. Skills

encompass a successful history of developing processes for clinical

production and commercial manufacturing. Extensive expertise in all types

of chromatography, ultrafiltration, diafiltration, viral treatment, aseptic

filling and validation. Expertise includes development of procedures and

documentation, performing scale up / tech transfer and organizing

production operations. Proficient in operation of purification systems at

both laboratory and commercial scale, including systems from GE,

Technikrom, Pall and Millipore. Major accomplishments include:

. Development and operation of commercial scale productions for 2 FDA

approved and 1 EMA approved biopharmaceutical products.

. Development and training of production personnel for the above

biopharmaceuticals.

. Conducted scale up and technical transfer of more than 25 processes from

research to clinical production and manufacturing. Transfer

accomplishments included generation of GMP procedure and documents,

equipment selection, materials acquisition and process implementation and

execution.

. Designed, constructed and launched multiple facilities for GMP

operations.

. Prepared, approved and executed validation protocols for equipment

qualification and process verification.

. Authored process summary reports, investigations and corrective actions.

PROFESSIONAL EXPERIENCE

Teva Biopharmaceuticals, Rockville, MD 2012

Biopharmaceutical Development & Clinical Production

Process Development Contractor

. Developed and screened various purification methods for producing

clinical grade monoclonal antibodies. Methods evaluated included

affinity, ion-exchange and hydrophobic interaction procedures.

. Performed ultrafiltration / diafiltration of candidate molecules as part

of the purification process development.

. Performed analytical evaluation in support of the development operations,

including SDS-Page and Spectrophotometric analysis. .

Qiagen Inc. Gaithersburg, MD 2008 - 2011

Diagnostics Manufacturer

Scientist III, Technical Operations

. Planned, designed and implemented activities independently to develop and

validate processes at scale under GMPs. Successfully performed scale up,

technical transfer and validation of a biological diagnostic product to

manufacturing.

. Wrote and executed validation protocols to verify standard pilot plant

operating processes.

. Performed HPLC purification of a monoclonal antibody used as a diagnostic

reagent.

Lonza Inc. Baltimore, MD

1999 - 2007

Biopharmaceutical Contract Manufacturer. Began with Baltimore BioScience

which Cambrex acquired in 2001 and Lonza acquired in 2007.

Senior Process Engineer, Manufacturing Sciences

2007

. Established a downstream Manufacturing Sciences group to perform all

investigation and corrective actions for purification and downstream

anomalies and excursions. Provided all product / process summaries for

production operations and analytical results.

. Performed the scale up & technical transfer of processes from laboratory

development to production. Process transfer includes all types of

chromatographic purification, buffer preparation,

ultrafiltation/diafiltration and aseptic filling. .

ROBERT M. SUYDAM

Page 2 of 2

Purification Manager

1999 - 2006

. Technical lead for production of client biopharmaceuticals, from

bacterial and mammalian cell culture sources. Produced purified bulk

biopharmaceuticals for clinical phase 1, 2 & 3 trials.

. Successfully produced phase 3 products and obtained FDA and European

licenses for two client products. Operated the production of these 2

commercial products.

. Scaled up and executed ion-exchange, affinity, hydrophobic interaction,

reverse phase and gel filtration chromatographies in both low pressure

and high pressure applications.

. Scaled up and executed ultrafiltration and diafiltration procedures to

accommodate production goals.

. Prepared and reviewed production records and SOP's for process

operations. Authored all downstream process summaries, data summaries,

investigations and corrective action reports.

. Developed and executed all downstream equipment and process validation

protocols and summaries..

V.I. Technologies, Inc. Melville, NY

1995 - 1999

Producer of virally inactivated blood components. Formerly Melville

Biologics.

Manager, New Product Development

1996 - 1999

. Scaled up and performed technical transfer of "Fibrin Sealant", process

from laboratory to pilot plant volume with application of proprietary

viral inactivation procedures.

. Produced fibrinogen and thrombin proteins, used in "Fibrin Sealant" for

clinical phase 2 & 3 studies..

. Performed design review and equipment selection for construction of a

Small Volume Manufacturing Facility (SVMF), to be used for the commercial

production of "Fibrin Sealant" or other proteins.

. Reviewed and executed validation protocols for qualification of the SVMF.

. Authored the purification process portion of the European regulatory

submission documents.

Senior Scientist 1995 - 1996

. Developed the purification process (laboratory scale) for isolation of

fibrinogen and thrombin proteins using reversed phase and ion exchange

chromatographies.

. Developed precipitation methodologies for impurity removal and product

concentration.

. Developed viral inactivation procedures for production of clinical

product.

. Specified, designed and purchased the clinical manufacturing process

equipment for the pilot plant.

. Prepared the batch records and SOP's for clinical production of the

fibrinogen and thrombin proteins.

Hoffmann-La Roche Inc., Nutley, NJ

Pharmaceutical Manufacturer

Scientist, Biopharmaceutical Production Department 1990 - 1995

. Supervised purification operations in the Multiproduct Cell Culture

Protein Purification Facility (MPCCPPF). Duties included execution of

manufacturing operations as well as supervision of a production

analytical support lab. Produced clinical material and demonstration lots

for facility launch.

. Downstream technical expert for all aspects of MPCCPPF purification suite

construction. Designed and assembled custom purification chromatography

systems. Reviewed and executed facility utility and downstream validation

protocols.

. Developed downstream GMP operating documentation, production records &

SOP's.

. Supervised the commercial scale purification of Interferon alfa-2a

(Roferon-A). Managed 2 affinity, 1 ion exchange, 1 gel filtration and 3

ultrfiltration / diafiltration operations. Performed process

investigations, inventory control, environmental monitoring and

supervised a process analytical support laboratory.

. Developed and supervised a facility for production of polyethylene glycol

(PEG) modified Interferon alfa-2a. Produced all of the modified product

for phase 1 & 2 clinical studies.

EDUCATION

MS Biochemistry Fairleigh Dickinson University, Teaneck, N.J.

BA Chemistry Rutger's University, Newark, N.J.

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