Technician Engineer

CHRISTOPHER F. SOMMA

*** ****** ***** **** 215-***-****

Pottstown, PA, 19464

******************@*****.***

Scientific professional and technician with over 18 years experience in FDA

highly regulated environments. Specialized Class-A/sterile expertise in a

wide variety of GMP climates including aseptic manipulation, fractionation,

ultracentrifugation, fermentation, purification, serial dilutions, cell

line propagation and potency testing.

Goal-oriented team leader able to effectively utilize staff and resources,

identify areas for process improvement and productively manage

relationships with key stakeholders. Recognized as an outstanding

contributor who exceeds expectations by readily accepting new roles and

additional responsibilities to drive the team's success. SAP literate and

LSS/Yellow belt certified.

PROFESSIONAL EXPERIENCE

Sept 2010 - Dec 2013 Supervisor, Barrier Operations Merck & Co.

Inc., West Point, PA

Sterile Formulation &Filling of GARDASIL ,RECOMBIVAX HB , and VAQTA

Vaccines

Frontline supervisory role involving direct oversight of all aspects of a

dynamic Alum-based recombinant in-line Formulation and Filling vaccine

operation in a cGMP regulated facility.

. Successfully conducted ongoing management of 12 direct reports including

payroll, annual training, one-on-one coaching and safety/compliance

adherence. Drove numerous off-shift training requirements including

annual Health Surveillance, Quarterly GMPs, and vision inspector

qualification in order to remain compliant. Manufacturing-HR liaison

responsible for candidate recruitment and selection.

. Ongoing direct hands-on management of dept tank & utility CIP/SIP

cycles. Extensive experience supporting and executing continuous and

cleaning validation protocols.

. Effectively partnered with and developed collaborative cross-functional

relationships with Operations support staff (Engineering, Validation,

Quality, Safety, and Deviation Management) in order to drive quality and

compliance.

. Successfully developed and implemented corrective actions in response to

process deviations, in order to ensure accurate transfer of sterile

product inputs. Designed Formulation trouble-shooting photo library job

aid to build more self-reliance and consistency across shifts. Authored

and updated numerous Standard Operating Procedures to ensure ongoing

compliance and continuous improvement.

March 2005-Sept 2010 Lab Technician, Virology Merck & Co.

Inc., West Point, PA

Tissue Culture Safety Testing

. Tested safety of Measles, Mumps, Rubella, Varicella and Hepatitis-A

vaccines using various tissue cultures cell lines.

. Screened for contaminants present in tissue culture fluids evidenced by

cytopathic effects.

. Screened for presence of noncytopathogenic viral agents via

hemadsorption method.

Varicella Potency Testing

. Determined potency and identity of production/MRL procured Varicella

vaccine samples.

. Determined Varicella vaccine efficacy through virus serial dilutions and

inoculation into MRC-5 tissue cultures cell line, incubation and

maintenance of test cell cultures, stain cell cultures and plaque count

potency calculation. Dept 223 Scheduler, Facilitator, and Acting Group

Leader.

. Masterfully developed Scheduling/Trending Excel Spreadsheet that

quantified the organizations staffing discrepancies.

. Successfully participated in Plaque Assay Cycle Time Reduction Kaizan &

Varicella Low Potency Kaizan.

. Drafted and implemented Dept tray diagram tool.

. Effectively fulfilled role of dept scheduler/facilitator/Tier-1

coordinator.

March 2003-March 2005 Bio Technician, VAQTA Merck & Co. Inc., West

Point, PA

. Performed production activities related to manufacturing of Hepatitis A

vaccine including media prep, cell expansion, purification, inactivation

and alum processing.

Feb 1999-March 2003 Bio Technician, Pneumovax 23 Merck & Co.

Inc., West Point, PA

. Successfully executed scale-up fermentation of live infectious

Meningitidis and Haemophilius Influenza Bacteria. Purified microbial

fermentation broths and extracted intermediates in PedVax and PneumoVac

vaccines. Conjugated chemically derivatized polysaccharides to N.

Meningitidis to produce final vaccine.

. Performed alcohol fractionation, ultracentrifugation and diafiltration

of fermentation products.

. Separated, isolated and purified intermediate product solutions by batch

or continuous, medium centrifugation. Purified product batch using

multiphase extractions and resin absorption methods.

. Chemically bonded purified polysaccharides and conjugated them to N.

Meningitidis protein to produce final vaccine.

Feb 1996-Feb 1999 Validation Engineer Wyeth-

Ayerst, Marietta, PA

. Successfully participated in an FDA audited validation and start-up of

the Wyeth-Ayerst Influenza Vaccine Production Facility (IVPF).

Effectively authored and executed all aspects of the Scientific Climate

Systems Egg Chiller Validation Project. Successfully authored and

implemented IQ/OQ/PQ protocols for controlled temperature rooms,

refrigerators and freezers.

COMPUTER SKILLS

SAP and PAS-X Werum Software SCADA/Delta-V/PI.

MS Office (Word, Excel, Outlook) LIMS/HANdel

EDUCATION

West Chester University- West Chester, Pa

B.S. Microbiology

DeSales University-Lansdale, Pa

MBA, Project Management-Current Enrollment

INTEREST/COMMUNITY ACTIVITIES

. Owner/manager residential leasing/consulting real estate LLC.

. Staff and Oversee all-volunteer Faith-Based Correctional Outreach.

Contact this candidate