Quality Control Management

JOYDEEP BASU

** ******* ******, *** #****,Newton, MA 02461 917-***-**** ******@*****.***

BIOTECHNOLOGY PROFESSIONAL

Dynamic, versatile Leader in the Biotechnology field with 19+ years experience in all aspects of the Biopharmaceutical industry. Exceptional technology skills combined with proven ability with cell based assays, ELISA's, manufacturing, validation and quality systems. Strong experience running a cross-functional GMP lab with biological and analytical mix as well as selecting and implementing a LIMS system. Outstanding strategist distinguished for proven leadership and team-building skills and excellent conflict resolution abilities. Demonstrated management and quality control skills that enhance productivity and drive sustained organizational performance.

AREAS OF EXPERTISE

Strategic & Tactical Planning ● DNA Isolation and Purification ● Bacterial Cultures and Cloning ● DNA Restriction Digestion ● Sterile Techniques ● HPLC Based Assays ● Protein Extraction ● Western Blots Agarose Gel Electrophoresis ● ELISA ● Cell and Tissue Cultures

Basic Cell Line Maintenance ● Procedure Writing ● Neutralization ● Competitive Analysis

FTIR ● UV Spech ● Water Testing (TOC, Conductivity, pH)

PROFESSIONAL EXPERIENCE

Bluebird bio, Cambridge, MA

Senior Quality Control Manager, Aug 2015-April 2016

Manage the transfer and validation of bio-analytical methods from Development to QC as well as the transfer and validation of methods to a contract-testing lab (validation of methods will be phase appropriate)

Showed effective leadership including developing and implementing objectives as well as business strategies including multi-test organizations able to test multiple products

Ensure close collaboration of the QC organization with analytical R&D project leads to ensure test method reliability throughout development

Establish specifications and testing process of raw materials and develop in-process and final specification system for drug substance and drug product of bluebird bio cell therapy product

Establish user requirements for purchase, qualification of bluebird bio’s QC analytical equipment and work with internal and external resources to maintain equipment in an optimal state

Monitor and trend data

CMO and OTL tracking to complete lot disposition

Complete routine record review of test data and related documents for in-process testing, drug substance and drug product release (generation of CoAs for product release)

Assist in the preparation of dossiers and data packages for interactions between bluebird bio’s and regulatory agencies

Interact with agents from regulatory agencies and participate in Pre-Approval Inspections

Develop, revise and review SOPs, qualification/validation protocols and reports

Conduct investigations regarding out of specifications (OOS) results, address and manage deviations related to analytical procedures and provide updates at daily and weekly meetings

Prepare, execute, and review deviations, change controls, CAPAs, OOT/OOS

Monitor the GMP systems currently in place at CMO/CTOs to ensure compliance with documented policies

Manage the stability study program. Includes evaluation of CMO/CTOs partners, processes with an eye for bringing in new capability including stability monitoring and statistical analysis.

Review proposed changes to systems, procedures, methods, and submissions to regulatory agencies, as appropriate

Prepare and review CMC sections of regulatory filings

Gather metric information for use in continuous improvement of areas of responsibility

Work as part of a cross-functional team to lead QC activities for technology transfer of manufacturing and testing processes to external CMO/CTOs

Manage release and stability testing for starting materials and drug product

Management of data review, analysis, identification of trends, and complex problem solving

Management of assay troubleshooting and identifying and implementing improvements to

existing assays.

Responsible for writing and presenting objectives for staff including: 4 Quality Control Analysts

IMMUNOGEN, Norwood, MA

Quality Control Manager, April 2007-July 2015

Responsible for overseeing and executing Drug Substance, Drug Product and Raw Materials testing in a CBER-FDA regulated laboratories.

Analytical testing was performed on all In-Process, Stability and Finished Products.

Qualify CBER References for methods.

Trained entry level analytical chemists, as needed.

Monitored total carbon via steam and water sampling utilizing Hach Anatel instruments.

Performed Compendia and monograph testing of Drug Products and Raw Materials. Main tests included: Identifications (Visual, pH, manual titration as well as auto-titration), Sodium Chloride and Sodium Bicarbonate Assays, and Glycerin confirmation via FT-IR.

Updated Standard Operating Procedures and conduct investigations on Out of Limit testing results as needed.

Reviewed and verify documentation related to the release of products. Assisted the Validations department with IQ/OQ/PQ (Installation Qualification, Operational Qualification and Performance Qualification) on instruments and software housed in the Quality Control Chemistry area, for verification and validation purposes

Integral member of management to help assist in developing staff and career objectives

Helped develop strategies and implementing processes to continuously improve data management practices including being quality control representative in both LabWare LIMS and CATSWEB implementation into company.

Perform review of all product release and stability testing for all QC functions for a laboratory setting

Received over 15 internal partner and Contract Manufacturing Operations audits and 2 Regulatory Audits

Analysis of in-process samples and finished samples

Setup a successful Quality Control lab developing and validating chemical and biological test methods for the characterization and testing of the product

Established an assay performance monitoring system which helped in the identification and tightening of assay variability

Problem solved using Root Cause Analysis tools for nonconforming materials

Authored and implemented Quality and Laboratory Standard Operating Procedures

Produced and initiated a new laboratory training program

Purchased and implemented new analytical technologies in the Quality Control lab

Participated in managerial leadership training

Provided quality control support for Product Development and Contract Manufacturing to ensure compliance with company, compendia, and regulatory requirements

Assisted CMOs in improving their quality systems while working on technology transfer for clinical manufacturing and testing

Responsible for writing and presenting objectives for staff including: 2 Supervisors, 2 Bioassay Analysts, 2 Chemistry Analysts and 2 ELISA Analysts

Provided technical and regulatory guidance to clients in early and late stage of drug development

Implementation of Risk Assessment and Quality Risk Management at internal and external manufacturing sites

Support regulatory in submission of variations

Transfer all Quality Control assays to several CMO’s for three internal products

Designed, created and implemented Standard Operating Procedures for new laboratory equipment as well as trained staff members on equipment

Use established GMP protocols to report data from ELISA and Bioassays for Quality Control

Manage and maintain documents for management, external collaborators, and regulatory agencies

Conduct thorough investigations resolving complex and unusual problems and issues, determine root causes, and recommend corrective actions

Provide technical and compliance oversight from a Quality Control perspective on all contract labs for virus testing, master cell bank testing, and working cell bank testing

Assist with departmental budget including equipment, and supplies

Strategic implementation of Corporate Quality Systems, policies and departments to support and initiate GMP manufacturing

Reduced QC expenditures by transferring analytical methods from contract facilities to QC for testing of final product and stability samples

Chair of the Specification Review Board

Experience in Quality Control of the raw materials to manufactured drug

Strong working knowledge of technical and quality concepts of the manufacturing and testing of pharmaceutical/biotech products

Strong working knowledge of cGMP principles with respect to US, EU, and other relevant regulatory guidance

Experience in reviewing and approving cGMP related documents (SOPs, protocols, reports, batch records, etc.)

Solid understanding of CMC requirements for INDs, BLAs, and other regulatory filings

Proficiency with enterprise systems, i.e., documentation, LIMS (analytical data management), LMS (learning management systems), deviations, CAPA, etc.

Experience in participating in deviation investigations, determining root cause, and developing corrective action plans

Ability to identify technical problems and suggest resolution of the issues

IMCLONE SYSTEMS, Somerville, NJ - April 1997 – March 2007

Quality Control Molecular Biology Supervisor, (2004-2007)

Supervised, and delegated workload to a team of 5 biochemists in the QC Molecular Biology Department

Wrote technical transfer and qualification protocols and reports for all cell based and ELISA assays for 5 new antibodies that were transferred into a new commercial facility

Reviewed all ELISA, cell based, and gel assays tested for release of drug substance and products

Quality Control liaison with contract laboratories, and contract manufacturers, ensured compliance by performing audits, and internal inspections

Quality Control Biochemistry Supervisor, (2001-2004)

Supervised and delegated workload for a team of 6 to 8 biochemists in the Quality Control Biochemistry Department

Ensured that all staff adhered to cGMP practices during work tasks

Assigned laboratory workload and analysis with appropriate biochemical test methods

Provided assistance to coworkers for troubleshooting laboratory investigations

Quality Control Scientist I, (1997 - 2000)

Developed and performed ELISA and cell based procedures.

Performed calibration of instruments including HPLC, dissolution tester and UV Spectrophotometer

Familiar with Wet Chemistry Techniques including pH testing, Viscosity testing and Sampling Techniques

Protein Chemistry - Responsible for preparing related buffers and solutions for daily lab use. Performed pilot testing on primary protein of interest via Ion Exchange Chromatography and Affinity Chromatography.

Introduced protein of interest into various matrices, sample preparation and analysis. Tests included: HPLC (Reverse Phase/Size Exclusion: Waters Instrument with EmpowerPro2 Software), Bradford Assay, BCA Protein Assay, and ELISA.

Maintained laboratory notebooks and supplemental data binders

Performed microbiological procedures including microbial limits and bioburden

Created, maintained, and managed SOPs for Bioburden Suite Gowning, Sanitization, and Environmental Monitoring

Developed, qualified and validated the cell based assay that was approved by the FDA

Performed and analyzed environmental monitoring of the manufacturing area and personnel

UNIVERSITY of MEDICINE and DENTISTRY, Piscataway, NJ 1994 - 1997

Research Assistant,

Managed and maintained cell culture, growing, harvesting, and propagation of various cell lines for biochemical experiments

Performed assays with use of Florescence Activated Cell Sorter

Preparation of Bacterial Plasmid DNA by: Miniprep and Midpreps by Alkaline Lysis and Quagen Kit, and Basic Protocol: Purification by CsCl Equi. Cent.

Maintained and managed the mice for research including: daily injections when performing experiments as well as sacrificing and dissection of mice.

EDUCATION

Hunter College, New York, NY, Master's of Public Health

University of Rochester, Rochester, NY, Bachelor of Arts in Biology

Boston University, Boston, MA Executive Masters in Business Administration –In Progress

Proficient in: Mac OS9.x / X and Windows / XP Operating Systems / MS Office / DNAStar / LaserGene / BioRad / Molecular Analyst / Molecular Devices Softmax PRO / SPSS Science SigmaPlot / Adobe PageMaker / Adobe PhotoShop / GraphPad Prism / STATLIA / KC4 / PLA / JMP

PROFESSIONAL MEMBERSHIPS

Parental Drug Association

America Society for Quality

American Association of Pharmaceutical Scientists (AAPS)

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