Simin D. Saadipour

** ***** **** 978-***-****

North Andover, MA 01845 acejxa@r.postjobfree.com

Senior Research Scientist

Highly skilled professional and certified Clinical Research Associate (CRA)

with strong background in laboratory environments within biotechnology,

biomedical, and pharmaceutical industries. Expertise performing HPLC,

protein purification and separation, and ELISA assays. Plans, executes, and

documents well-designed experiments in accordance with GLP, GMP and study

protocols. Completes accurate technical reports; evaluates and interprets

data and analyze variances. Assists in developing and revising lab

documents for compliance with GMP, GLP, and GCLP. Knowledgeable of ICH GCP

giudelines. Experience of lean manufacturing principles and proficient with

SAP, MFG/PRO enterprise resource planning (ERP) and

Enterprise Quality Management System (EQMS) Trackwise software application.

Utilzed Trackwise software to manage change control, and validation .

Mentors and trains junior lab associates and exhibits participative, hands-

on leadership style. Experienced with Method Transfer to, and from CRO .

Thrives in collaborative team environments; maintains sense of ownership of

projects and displays unwavering commitment to quality, accuracy, and

reliability of investigations, data, and experiments. Dedicated, valued,

and respected associate recognized for superior work ethic, strong

attention to detail, and innovative approach to problem solving. Proficient

with various molecular and cell biology techniques and equipment,

including:

Cell culture ( mammalian and Hi5) ( Baculavirus Expression (Formulation (

Protein Separation ( Protein Purification (

Gel Filtration ( QA/QC ( HPLC ( Affinity Chromatography

Experince With Large Molecule assays ELISA, Small Molecule Assays LC-MS

Electrophoresis ( Enterobacteriaceae Identification ( Pure Culture

Preparation

Bacterial Population Counts ( Protein Synthesis ( Turbidity Measurement (

Quality Control

cRNA Microinjection ( API 20 E System Spectrophotometer ( Streak Plate Pour

Plate ( MFG Floustar

Mass Spectrometry ( Chondrocyte Cell Culture ( Autologous Keratinocyte

Graft

Professional Experience

Altran Contracting,Currently located at Genzyme Allston, MA. 2012-

present

Senior QC Analyst

Supporting verification of Compendial methods and transfer of validated

analytical method within the quality Control Chemistry laboratory at

Allston and other Genzyme facility by Initiatiating method transfer

proposal, Plan, performing Gap analysis, Gap remedation, and Risk

assessment. Writing transfer protocol, Coordinating execusion of transfer

protocol and writing transfer completion report.

As Trackwise change owner, facilitate implementation of new methods or

changes to existing methods by initiating a change Control request and

coordinating SME assessments, assign action items to involving

departments, review and approval of completed action Items in Trackwise

and preparing closure statement to finalize a change request.

Simin D. Saadipour, continued acejxa@r.postjobfree.com

ICON CONTRACTING SOLUTION Cambridge, MA ( 2009 - 2012

Clinical Research/QC Lead

Contracted to ensure the seamless method transfer from an R&D environment

to an Assay Service Laboratory (ASL), a GLP lab established by the QC

team. Worked closely with the Bioanalytical Principal Investigator (BPI)

to prepare protocols, SOP, and proper forms for method validations or

sample analysis. Managed all phases of method validation of Ligand

Binding assay including review/assessment of all performed assays

against acceptance criteria, collaboration with BPI to create validation

report, preparation/audit of sample analysis, and development of sample

analysis report.

> Key member of the team that successfully established the GLP lab,

bringing the contract research function back in-house for Biogen and

generating significant cost savings from outsourcing to other CROs.

BD DISCOVERY LAB, Woburn, MA ( 2005 - 2009

Lab Associate II

Supported design and development of products for molecular/cell biology,

bioscience research, cell analysis, and immunocytometry. Collaborated

with team lead to conduct investigations related to product testing.

Prepared antibodies, reagents, culture media, and drug discovery

products. Performed cell culture and maintenance, baculovirus expression,

and protein synthesis. Conducted cRNA microinjection of Xenopus oocytes

for transporter protein study. Set up and ran QC assays, CYP inhibition

fluorescent assays, and CYP induction assays using HPLC. Reviewed and

released test results. Identified and initiated QC notification and

provided ongoing training and coaching to new hires.

> Consistently exceeded all expectations for the timely compeletion of

projects, leveraging organizational skills and troubleshooting

expertise to meet all project milestones.

> Recognized for instructional success in training new hires and

existing employees on all aspects of lab operations.

GENZYME BIORSURGERY, Cambridge, MA ( 2001 - 2005

Senior MFG Technician

Conducted experiments and investigations in class 10,000 clean room to

support development of biologically-based products. Performed cell

culture techniques to maintain autologous chondrocyte cells. Performed

inoculation, trypsinization, and cryopreservation; thawed chondrocyte

cells and assembled chondrocyte cells in GMP environment. Conducted QC

dynamic monitoring using RCS and MET1. Initiated events for

nonconformance and initiated corrective actions.

> Completed all related batch records and batch record reviews;

developed MS Access database to calculate percentage of batch record

returned after QA testing.

Simin D. Saadipour, continued acejxa@r.postjobfree.com

PERIODONTIST & IMPLANTOLOGY, North Andover, MA ( 1997

Office Assistant

Performed broad range of office duties, including managing schedules,

completing patient intake forms, and preparing pre-treatment statements.

Assisted physician during surgeries and procedures.

Additional experience included positions as Junior System

Analyst/Programmer and Programmer Assistant.

Education & Professional Development

Clinical Research Certificate - MASSBIO

Certificate in Bioinformatics - North Eastern University, Boston, MA

Bachelor of Science, Biology - Salem State College, Salem, MA

Associate of Science, Computer Information Systems - Queensborough

Community College, Bayside, NY

TECHNOLOGIES

Proficient with Identibacter Interactus Simulation Program, SAP, MFG/PRO, D-

Base III, Clipper, and MS Word and Excel.

Contact this candidate