over 15 years progressive experience with industry leaders in positions ranging from process r&d scientist-pilot research lab/gmp facilities coordinator and staff validation scientist bsv laboratory/study coordinator with merck & co., inc. to more recent positions with johnson & johnson as senior quality assurance associate and senior quality assurance specialist and culminating in title of quality & compliance liaison/manager ♦ comprehensive background in industry-related quality assurance, regulatory compliance, environmental, and occupational safety issues at state and federal levels ♦ well-versed in cgxp (gmp, gcp, glp, gtp) ♦ proficient in process / cleaning /mechanical / automation validation ♦ bs in biological science and biotechnology ♦ certified training through american society for quality (asq), parenteral drug association (pda) and international society of pharmacoepidemiology (ispe)

 

ø  member, johnson & johnson global pharma group procedural documentation council: procedural documentation harmonization initiative

ø  collaborated in development review and approval of quality agreement between j&j r&dqa, gpsg qa and 3rd party cros as well as review of j&j gr&dqa quality manual for advanced cellular therapies

ø  co-chair, johnson & johnson community of asian associates-diversity and inclusion affinity group

ø  co-chair, asian society for innovation and achievement  (a.s.i.a.) ccentocor, obi, gpsg chapter

ø  recognized with award of excellence for contributions to safety initiatives, merck & co., inc.

ø  member, merck & co., inc. site safety and industrial health committee and site environmental committee

ø  committee leader and representative, departmental safety and departmental environmental committees

ø  served as departmental site environmental engineering (see) and safety/industrial hygiene (sih) liaison, ensuring continual compliance with federal/state environmental and occupational safety regulations; merck & co. inc.-research laboratories

ø  successfully developed incompatible waste matrix for vaccine/biologics pilot plant as well as co-developed new employee safety manual, both used as models for mrl and mmd safety at merck & co. inc.

 

 

johnson & johnson family of companies-pa                                                                         2002-2010

quality & compliance liaison/manager, stem cell organization of b.i.o. r&d (sco)-radnor; 2007-2010

proactively liaised with cross-functional departments including pharmaceutical development, operations and quality, as well as strategic customers and partners to achieve critical quality and compliance objectives; interfaced on cell therapy projects with j&j quality groups in clinical regulatory and manufacturing

spearheaded oversight, alignment and execution of projects with external qa/qc partners through late-stage clinical development in areas spanning release testing, stability testing, test methods validation, development, and lab and product support, with consistent focus on on-time delivery

proficiently created, implemented and maintained quality systems for sco and led annual internal audits; developed, reviewed and approved gxp procedural documents including sop, work instructions, guidances, policy, manuals, technical reports, and batch records

played instrumental role in development, revision, application, maintenance, validation, review, preparation, routing, and control of quality standards documents and methods supporting successful submission to j&j quality groups or regulatory authorities

contributed subject matter expertise and dynamic leadership skills toward facilitating stem cell organization staff training compliance

page 1 of 2

 

yyyyyy x. yyyyyy                                                                                                               page 2 of 2

 

johnson & johnson continued

 

sr. quality assurance specialist, j&j pharmaceutical research & development-spring house; 2005-2007

promoted to support and provide guidance in broad initiatives ranging from automation/mechanical compliance for small scale clinical pilot plant, r &d computer systems validation compliance and new r&d new projects to fedbatch bioreactor and expansion projects

served on stem cell internal venture (sciv) fmea / risk assessment team (malvern bldg. 5 and sscpp) as well as sciv project team

proficiently reviewed and approved validation documents/protocols, sops, work order requests, preventative maintenance, and calibration alerts

offered expert qa support for early stage pilot plant commissioning and validation

 

sr. quality assurance associate, global biologic supply chain, llc-malvern; 2002-2005

focused on quality automation/ mechanical validation compliance for gmp biologics pilot plant facilities, with key projects ranging from r &d new projects computer systems validation compliance to gmp cell banking pilot plant and gmp resin and purification pilot plant start ups

actively supported qc assay methods for phase i, ii pilot plant, and manufacturing as well as qa systems

served as change control assessor/coordinator in support of pilot plant, r&d and manufacturing

 

merck & co., inc.-west point, pa                                                                                             1994-2002

staff validation scientist bsv laboratory/study coordinator, manufacturing div.; 2000-2002

specializing in bio/sterile validation, steered validation activities for filter, container closure validation and continuing validation studies; led renovation efforts for bsv lab and supported bsv-vte safety and environmental initiatives

effectively developed and executed cleanability and recovery studies for new and existing product within stringent timelines; supported and participated in filter and resin re-use studies

designed and integrated sops, calibrations, certifications, and training; efficiently coordinated and documented environmental monitoring functions and ancillary maintenance of equipment and facilities

strategically established and solidified proactive networks with site operational services, central engineering, plant services, and mmd maintenance to optimize collaborative achievement of goals

partnered in developing hplc/ftir methods for extractables

 

process r&d scientist-pilot research lab/gmp facilities coordinator, research labs; 1994-2000

proficiently coordinated and supported operation of vaccine manufacturing pilot laboratories and gmp pilot facility, with key focus on regulatory activities ensuring compliance with current good manufacturing practices (cgmp); actively participated in developmental and clinical (gmp) isolation/purification processes

efficiently scheduled use of developmental laboratories and pilot facilities supporting developmental and clinical operations; wrote sops for regulatory, facility and developmental/clinical operations

productively ordered, inventoried and tracked raw materials to maintain optimal levels as well as scheduled work orders for equipment/utilities maintenance to maximize operational performance

served as see an sih liaison for vaccine/biologics pilot facilities and oversaw coordination and documentation of environmental monitoring functions; created volatile organic solvent procedures for efficient solvent emissions tracking

 

prior: validation specialist, life sciences international-day & zimmerman-philadelphia; 1993-1994

 

 

bachelor of science, biological science and biotechnology, drexel university-philadelphia; 1992

 

 

member, ispe, asq and pda    

member, national association of asian american professionals (naaap)

 

 

volunteer, community outreach and my brother's house; benefiting homeless/underserved populations