Quality Assurance Supply Chain

Thomas J. Yajcaji

*** ********* ***** *****: **4

*** ****

Plainsboro, NJ 08536 Email:

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

Objective

Obtain a position in the Pharmaceutical/Biotechnology industry utilizing my

cGMP/FDA knowledge and diversified QA manufacturing experiences.

Professional Experience

GlaxoSmithKline (Stiefel Laboratories/Barrier Therapeutics); Princeton, NJ;

2007-2010

Director, Quality Assurance and Regulatory Compliance (solid dosage)

. Establish key Quality systems for company including: Quality Agreements,

complaints, document control, batch records, APRs, deviations, CAPA,

validation, and change control.

. Develop/Implement internal PAI program resulting in successful filing and

FDA inspection.

. Assist/train functional areas (clinical, development, operations) on

"stage appropriate" compliance systems regarding their departmental

systems/procedures for development products.

. Audit key sites (GCP, GMP) for phase III product, identify gaps, and

propose/implement solutions.

. Review analytical/process development reports, tech transfer, and

subsequent validations (protocols/reports).

. Provide QA oversight in supply chain for three commercial products.

Abbott Laboratories (KOS Pharmaceuticals, Inc.); Edison, NJ; 2005-2007

Director, Quality Assurance (solid dosage and inhalation)

. Responsible for establishment/maintenance of Quality systems associated

with internal

solid dose manufacturing facility and third party manufacturers.

. Streamlined supply chain by partnering cross-functionally and

reorganizing R&D,

Clinical, and Commercial QA.

. Provide guidance to operations/QC to successfully reduce supply chain

cycle times,

implementing "right first time" systems. Involved in high level

investigation resolution to

keep facility operating at capacity.

. Responsible for disposition of commercial product to market and

successfully meeting

sales/marketing forecasts.

. Successful FDA inspection after implementation of Quality Systems.

. Assisted R&D/Clinical/Commercial QA in developing robust, "stage

appropriate" Quality

Systems.

. Partnered with third party US and European manufacturers and raw material

vendors to

ensure FDA compliance.

. Development/mentoring of QA staff (responsible for five direct reports).

Palatin Technologies; Plainsboro, NJ; 2003-2005

Director, Quality Assurance (mAB and parenteral)

. Responsible for all QA activities (GMP, GCP, GLP, and

Development/Research)

associated with start-up virtual Biotech Company. Engaged with all

management levels

and consultants in establishing Quality systems/philosophies.

Responsible for four (4)

direct reports.

. Worked with Development/Research, GLP, GCP, and GMP groups to establish

"stage

appropriate" compliance systems and resolve issues.

. Establish/implement/manage QA systems for nasal delivery spray device

currently in

development for future NDA product.

. Guide European contractors (and within company) in establishing GMP

systems, resulting

in successful PAI for monoclonal antibody product. Established

packaging/labeling

systems with contractors.

. Draft Quality Agreements for various contractors.

. Prepare/implement QA project master plan for phase II chemical synthesis

product to

bring through FDA commercial approval.

Johnson & Johnson (Centocor); Malvern,PA; 1998-2003

Director, Quality Assurance (mAB continuous perfusion)

. Responsible for all QA activities (establishment and administration of

QA, QC, and

manufacturing systems) associated with start-up of API manufacturing

facility for

monoclonal antibody product. Successful PAI and EU inspections

granting facility

approval.

. Hire QA staff (five direct reports) to perform quality functions in the

facility, overseeing

auditing, raw material, change control, complaints, deviations, and

batch disposition.

. Responsible for pilot plant facility (clinical materials), final product

disposition,

complaints, and annual product reviews.

. Responsible for technology transfer of bulk API to third party

contractor. Successful PAI.

. Responsible for quality assurance budgets.

Apollon (Centocor); Malvern, PA; 1997-1998

QA Auditing Manager (DNA vaccines)

. Draft SOPs and policies for QA auditing system.

. Conduct internal and external GMP/GCP audits.

Chiron Corporation; St. Louis, MO; 1996-1997

Associate Manager, QA/QC (Mammalian cell culture fermentation)

. Direct QA and QC Microbiology staff (ten direct reports).

. Responsibilities included all QA functions and QC Microbiology for

clinical Biotechnology facility (mammalian cell culture).

. Direct QA staff in review of documents and resolving issues with various

departments.

. Establish QA auditing systems (develop SOPs, corrective actions).

. Assist in review of BLA.

. Develop and Manage QA/QC budgets.

Roche Carolina (Division of Hoffmann-La Roche); Florence, SC; 1995-1996

QA Coordinator (small molecule API)

. Responsibilities included establishing cGMP systems (master batch

records, investigation reporting, change control, SOPs, auditing, release

systems, annual product reviews) for start-up of API pilot and commercial

facilities.

. Review validation documents (protocols/executed packages) for facility,

including computer systems, utilities, and manufacturing.

. Perform cGMP audits of facility (manufacturing, QC, validation, etc.)

Hoffmann-La Roche; Nutley, NJ; 1990-1994

QA Coordinator (parenterals, liquids, creams, ointments)

. FDA liaison during government inspections. Responsible for coordinating

inspection with investigator and Roche personnel. Ensure investigator is

following requirements of FD&C Act. Assist various groups in responding

to agency findings.

. Review and approve master batch records, investigations, change controls,

SOPs, validation protocols, and executed validations (cleaning, process,

and equipment) for parenteral manufacturing.

. Perform audits of vendors and in various areas of production, including

in-process and QC laboratories.

. Provide cGMP assistance to production personnel.

Assistant Scientist, QC Microbiology

. Testing raw materials and finished dosage products as per USP for:

Growth Promotion, Microbial Limits, Sterility, Antimicrobial

Effectiveness, and Bioburden.

. Perform Microbiological validation studies.

. Supervise Lab Technicians.

MAS Laboratories; East Windsor, NJ; 1985-1987

Laboratory Technician

. Testing pharmaceuticals and raw materials for Microbiology/Chemistry

assays as per USP.

Education

Rutgers University; New Brunswick, NJ

Bachelor of Science in Biology; 1989

Professional Memberships

. Member of ISPE and PDA

. NJPQCA Certification in Quality Assurance

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