Quality Assurance Manufacturing

***** ******* ****** *** ****, California ***** 408-***-**** (cell)

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

OPERATIONS MANAGEMENT

Extensive experience in managing all phases of Pharmaceutical Manufacturing

operations including Solid Dose, Liquid and Cream products. Experience

also includes Quality Assurance, Packaging, Materials and Logistics

Management. Strong Technical background with a focus on troubleshooting

and layout of state-of-the-art production equipment. Specific expertise

in:

Production Planning / Inventory FDA / GMP Compliance

Management

Pilot Plant / Multi-Site Operations Plant / Operations Design

Staff / Contractor Management Technology Transfer

WORK EXPERIENCE

AMERICAN RED CROSS SAN JOSE, CALIFORNIA

Manufacturing Supervisor 2012 to 2014

. Supervised and scheduled staff of 7 technicians responsible for

storage and distribution of product for a 24/7 operation

. Ensure all operations follow SOP's and cGMP's

. Interact with other departments and customers to assure timely

deliveries.

. Perform daily inventory and review all documentation pertaining to

orders.

. Assure/improve compliance in working area with all environmental,

safety and quality programs.

. Performed annual performance reviews for direct reports

DSM BIOMEDICAL BERKELEY, CALIFORNIA

Supervisor, Device Manufacturing 2008 to 2012

. Analyzes and plans work force utilization, space requirements, and

workflow, and participates in the design layout of equipment and

workspace for maximum efficiency.

. Supervise direct reports to assure they have the training, knowledge

and resources to perform their duties. Assure that all training is

properly documented.

. Assure/improve compliance in manufacturing areas with all

environmental, safety and quality programs.

. Interact with other department heads relative to day to day plant

operations to assure timely delivery of products to the customer.

. Work with new customers and R&D regarding design efforts of product

lines, and all other corporate related special assignments as

directed.

NEKTAR THERAPEUTICS SAN CARLOS, CALIFORNIA

Production Supervisor 2004 to 2008

. Supervised and scheduled staff of 10 technicians responsible for

clinical production

. Supervised and performed, as required, daily operations in dispensing,

warehouse, and spray drying

. Interfaced with QA, Process Development, Engineering, Environmental

Monitoring, Validation, Maintenance on a daily basis

. Performed investigations and wrote investigation reports for

discrepancies

. Revised, updated and/or developed new process records and SOPs

. Supported various clinical programs from lab scale to phase III

including optimization and scale up to commercial scale

. Performed annual performance reviews for direct reports

Arthur R. Sykes Page 2

408-***-**** (cell)

ALZA CORPORATION MENLO PARK, CALIFORNIA

A Johnson & Johnson Company

Manufacturing Supervisor 1998 to 2004

Responsible for the day-to-day management of the production unit for

manufacturing liposomal drug products for pre-clinical, Phase I and

Phase II studies. Established and maintained necessary procedures to

ensure GMP compliance plan and schedule all production activities, and

supervise manufacturing operations. Worked with Development Scientists

and Engineers ensuring manufacturing input to the technology transfer

process. Provided input for the new Pilot Plant. Including the

selection and design of manufacturing equipment, utility placement, the

impact of personnel and material flow on facility layout, ensuring that

regulatory concerns are satisfied, and current industry standards are

upheld.

o Assisted in the successful integration of all Production Operations

into Johnson & Johnson after their acquisition of ALZA in 2001.

OREAD PHARMACEUTICAL MANUFACTURING

PALO ALTO, CALIFORNIA

Senior Manufacturing Technician 1998 to 1998

Participated in manufacturing and filling of sterile products following

SOP's and cGMP's. Reviewed batch records; revised SOP's and

manufacturing batch records. Involved in ordering new equipment for

upgrade of the sterile facility. Interacted with QA and other

departments to release needed materials for manufacturing.

MATRIX PHARMACEUTICAL, INC. 1993 - 1997

SAN JOSE, CALIFORNIA

Production Supervisor (1995 to1997)

Managed manufacturing activities at two sites. Provided active

technical leadership in the area of aseptic processing, including

training manufacturing and laboratory personnel in aseptic technique,

gowning, proper

material handling, material flow and safe manufacturing practices.

Worked alongside crew to manufacture sterile solutions and sterile

viscous protein gel products as well as the bulk intermediates required

as precursors to the manufacture of such sterile products. Wrote

Master Batch Records, and Media Fill

Records, Standard Operating Procedures (SOPs) and Component

Specifications. Led and provided input to investigations related to

product and process failures. Selected and supervised Process-

Engineering contractors.

Provided input for the design of a new manufacturing plant. This

involved the selection and design of manufacturing equipment, utility

placement, the impact of personnel and material flow on facility

layout. Directly involved in regulatory audits by the FDA. Addressed

concerns and questions generated by these agencies in support of

regulatory submissions.

Manufacturing Development Technician (1993 to 1995)

Worked closely with the Process Development and Validation departments

to implement new and scale-up existing processes. Developed SOPs and

component specifications for activities and materials pertinent to

manufacturing. Compounded bulk drug substances, prepared raw materials

for use in the process of enzymatic protein digestion, protein

concentration and purification by ultra-filtration/ diafiltration,

further protein concentration using a Membrex Concentrator, and the

filling of sterile injectable drug products.

SYNTEX LABORATORIES, INC. PALO ALTO, CALIFORNIA

Process Operator II 1992 to 1993

Responsible for the bulk manufacture of a wide variety of

Pharmaceutical products. These products included Liquid and Cream

(L/C) manufacture as well as Solid Dose Forms (S/D). Interfaced daily

with Validation, Quality Control and Quality Assurance personnel.

PROFESSIONAL AFFILIATIONS and CERTIFICATIONS:

1. State of California Pharmacy Exemptee License #EXC16016

2. Hazardous Material Emergency Response First Responder Operational

(ERT)

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