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Director Resume


Desired Industry: Biotech SpiderID: 57047
Desired Job Location: gaithersburg, Maryland Date Posted: 1/16/2012
Type of Position: Full-Time Permanent Availability Date:
Desired Wage:
U.S. Work Authorization:
Job Level: Management (Manager, Director) Willing to Travel:
Highest Degree Attained: Willing to Relocate:


Objective:
Senior Director level position


Experience:
PROFESSIONAL EXPERIENCE:

Biotech and R&D Professional, Scientific/Technical Expert and Leadership Role of Clinical and Commercial Product/device from concept to market

Director, Operations & Quality Systems (Site-Head of US Facility)
Gene Logic, Gaithersburg, MD, Mar. 2011 - Present

Oversight of GLP-compliant Genomics and Molecular Genetics facility, Site-Head of Quality Systems (QA and QC), Validation, material handling, facility monitoring, customer interactions and Regulatory Affairs, Product complaints, Development of Policies, Systems; Strategizing / Organizing projects, Improve efficiency and productivity, Developing /Organizing /Chairing team and management of multiple projects, Keep track of all projects against target, Continuous Improvement, Getting CLIA certification, Implementation of LIMS, Validation of Assays, systems, equipments and processes, Internal and external facility Inspections and QA/QC Audits, Write and Review reports, Management of Documentation, SOPs, Protocols, Continuous Improvement, Training, Management of Deviations, CAPA, Biotracker, Change control, Biorepository, Regulatory activities, FDA, ISO guidelines etc Interaction and management of contractors to assure quality and regulatory compliance,

Quality Sr. Specialist (Sr. Manager) Oversee of cGMP Bulk API and Finished product manufacturing, QA, QC, validation, training, Documentation, facility maintenance, material handling
Amgen, RI, May 2005 July 2009

Scientific Experience - Area of Cancer research, Virology, Oncology, Genetics, Cellular and molecular aspects of protein and/ or protein related molecules.

Quality Experience Quality, Safety, Accuracy, Potency and Efficacy of drug, device and/or product.

Quality Management:
More than 6 years of Quality experience in Federal Regulated Industries with an emphasis on current Good Manufacturing Practice (cGMP), Good Laboratory Practice (GLP), Good Clinical Practice (GCP), Quality System Regulations (QSR), International Conference on Harmonization (ICH), Human Biologics and Good Tissue Practice (GTP), as well as, ISO9000.
More than 6 years of CMC (Quality, Development and Regulatory) and Quality Supervisory and Management experience with focused responsibilities for Quality Assurance, Quality Control, Analytical testing, Review for Bioanalytics Laboratories (Biochemistry, Protein Chemistry, Cellimmunology, Microbiology, Raw Materials, Lab Support, Sample Management), Stability and Final Product, Product Process and Program Development, Labeling, Internal/External Audits, Inspections, Document Control, Process Improvement, Regulatory Compliance, Validation, Investigations, Change Control, Training, and Corrective and Preventive action functions. Upstream and Downstream Manufacturing.

Project Management:

Project Champion for more than 20 years of Project Management expertise with focused responsibilities for evaluation scope, objectives and goals, understand financial and resources planning, coordinate project-level budget and resources, develop and lead cross-functional team, Assess and Manage risks, Plan, schedule, execute and close on time, use of Microsoft Programs (SAP, ePPM, Gantt, PERT, COGNOS), negotiate with team members to resolve issues, Track team performance against objectives, meet or exceed timelines.
Thorough Knowledge of Product Process Development, Different stages of Product Life-cycle from microscope to market, clinical trials from pre-clinical to clinical III stage and clinical IV stage activities, write, revise or edit SOPs, Protocols and Technical Reports, DOE, ANOVA, Data management and analysis, Create, evaluate, coordinate and develop product plan, strategies and scope, Technology transfer.

General Management:

Oversee all aspects of Quality Control functions analytical testing, method development / optimization, technology transfer, qualification, implementation and validation, process validation, laboratory compliance, and risk management.
Plan, prioritize, organize and responsible for day to day operation of multiple laboratories (Cell Immunology, Biochemistry, Protein Chemistry, Microbiology, Raw Material, Molecular biology and Lab Support) including development and execution of several assays, protocols, standard operating procedures, data presentation / interpretation, supervision of staff.
Communication and coordination of global and site specific activities within Amgen for continuous improvement and operational excellence of laboratory methods, optimization of laboratory processes/systems. Interaction with Executives / Directors, collaboration within Amgen to share best practices and bring forth consistency in the QC laboratories that support commercial drug substance and drug product supply.
GMP, GLP, GTP, GCP and ISO guidelines,
In-process, stability, Release material testing and review, and Disposition
Internal/External Audit
Regulatory activities for lot release
Regulatory filing (IND, NDA, BLA)
Compliance, Risk assessment and management
FDA and EU Guidelines, ICH
Writing and review of technical reports, protocols, Standard Operating Procedures, medical briefings, articles
US Pharmacopeia (USP) guidelines for product quality and performance test and water, European Pharmacopeia (EP)
Regulatory liaison with FDA
Statistical Analysis of Data (ANOVA)
Investigation, and Product Quality / Safety Program
Enterprise Document Management System (EDMS)
Laboratory Information Management System (LIMS)
Learning Management System (LMS)
Fast Start in Project Management (FSIPM)
Operational Excellence
MAXIMO
Corrective And Preventive Action Program
Global Project Portfolio Management (ePPM), PERT, GANTT
Vendors/customer negotiation
Design Of Experiments (DOE)
COGNOS
Change control Management System (CCMS)
Validation Program
Automation of ELISA (Tecan)
Manufacturing process from inoculum to production to purification
Sample Management / Sample Repository


Senior Biologist, Oct. 2001 May, 2005, GS-12/Step 6
National Institute of Health, National Cancer Institute, Bethesda, MD 20892.
Experimental Transplantation & Immunology
Supervised / guided graduate students, associates, summer students and technicians
Reviewed /wrote grants and manuscripts
Kept abreast with update literature and technologies
Attended and presented data in conferences, meetings, seminars and symposium

Senior Scientist, July 1999 July 2001
GlaxoSmithKline Beecham Pharmaceuticals, King of Prussia, PA 19406.
Department of Immunology - Drug Discovery
Served As Lab manager
Supervised / guided graduate students, associates, summer students and technicians
Reviewed /wrote grants and manuscripts
Kept abreast with update literature and technologies
Attended and presented data in conferences, meetings, seminars and symposium

Senior Post-doctoral Associate, 1995-1998
Department of Biochemistry and Molecular Biology, Thomas Jefferson University, Philadelphia, PA 19107
Supervised / guided graduate students, associates, summer students and technicians
Reviewed /wrote grants and manuscripts
Kept abreast with update literature and technologies
Attended and presented data in conferences, meetings, seminars and symposium

Senior Post Doctoral Fellow, 1992 - 1995
Fels Institute for Cancer Research and Molecular Biology, Temple University, Philadelphia, PA
Supervised / guided graduate students, associates, summer students and technicians
Reviewed /wrote grants and manuscripts
Kept abreast with update literature and technologies
Attended and presented data in conferences, meetings, seminars and symposium


Principal Accomplishments:

Explored the mechanism associated with V-src mediated transformation of myeloid cells (32Dcl3).
Constructed the chimeras between v-src and v-fgr oncogenes (protein tyrosine kinases).
Demonstrated the effect of src/fgr chimeras on IL-3 dependence of 32Dcl3 cells.
Characterized the activation of STATs by v-src, v-fgr and src/fgr chimeras.
Analysed the tyrosyl phosphorylation of STAT proteins by v-src and src/fgr chimeras.
Examined the translocation of STAT proteins to the nucleus.
Established the inactivation of JAK kinases by v-src and src/fgr chimeras.
Demonstrated the co-immunoprecipitation of STAT proteins with v-src antibodies.
(MCB, 1997)

"ROCKEFELLER FOUNDATION" Post Doctoral Fellow, 1989 - 1992
Department of OB-GYN, University of Pennsylvania Medical Center, Philadelphia, PA
Supervised technicians and summer students
Kept abreast with literature and advanced technologies
Reviewed and wrote grants and manuscripts
Attended and presented data in conferences, meetings, seminars and symposium

Principal Accomplishments:

Established the Proacrosin being synthesised principally by round spermatids and detected in early and late spermatids.
Characterized the maturation of Proacrosin from higher molecular weight to lower molecular weight form after posttranslational modifications.
Examined the structural changes in the Proacrosin protein of cauda epididymis from Acrosin of testicular form.
Demonstrated the greater molecular weight of Proacrosin in spermatids than in cauda epididymis.
Determined the proacrosin being modified in corpus region of the epididymis.
Demonstrated the molecular weight conversion during epididymal maturation.
(MRD, 1991: MRD, 1991)

Side Projects: Development of biological assays to characterize the antispermatozoal antibodies
HONORS AND AWARDS:

Rockefeller Foundation Post Doctoral Fellowship Grant (Univ. of Pennsylvania, PA).
Research Scientist (Fellowship from Indian Council of Medical Research, India).
Research Officer (Fellowship from Indian Council of Medical Research, India)
Merit Fellowship from "Indian Council of Medical Research" during Doctoral degree.
National Merit Scholarship during Undergraduate and post-graduate.
National Workshop on "Use of Visual Techniques in Teaching Biology", University Grants Commission.



Education:
EDUCATION:

Ph.D. (Molecular Biology & Biochemistry), King George's Medical College, Lucknow, India, 1990
Title of the Ph.D. Thesis: "Effect of Drugs and Steroid Hormones (Progesterone, Testosterone, and Estrogen) on the mammalian testes"

M.S. (Molecular Biology & Biochemistry), University of Lucknow, India

B.S. (Molecular Biology, Biochemistry & Chemistry), University of Lucknow, India

Major Sources of Study: Recombinant DNA technology, Molecular Biology of the gene, Molecular Cell Biology, Biochemistry, Molecular Genetics and Developmental Biology, Inorganic, Organic and Physical Chemistry.

TECHNICAL EXPERTISE:

RNA Isolation, Northern, DNA Isolation and Southern blotting
DNA Sequencing, RT-PCR, Site-directed mutagenesis.
Construction and Screening of cDNA and Genomic libraries
Cloning and subcloning, Genomic Restriction Mapping
CAT Assays, Gel Shift Mobility Assay
Preparation of retroviral vectors, Virus titration
FACScan, Analysis by CellQuest.
Human and mouse cDNA microarray.
Peripheral Blood Mononuclear cell isolation
In vitro Transcription and Translation assays, Kinase assay, Cell cycle Analysis
Cell Isolation, Tissue Culture, Transfection and Transformation
Protein Purification and Characterization
Antibody production and purification
HPLC, LC/MS, Column Chromatography, and Affinity Chromatography
1D, 2D-Gel Electrophoresis, Western blotting, and Immunoprecipitation
Differential and Density Gradient Centrifugation
Spectrophotometry, ELISA, RIA, and Enzyme Kinetics
Electron and Fluorescent Microscopy, Immunohistochemistry
Microinjections to the animals, embryos
Proteomics (protein-protein interaction)
Genetics


Affiliations:
TEACHING AND COMMUNICATION SKILLS:

Instructor/ Faculty: Taught Biology I & II (Human Anatomy, Physiology, Biology) in Community College of Philadelphia, PA 1990 - 1992.
Conducted lectures in Biochemistry, Molecular Biology and Cell Biology.
Experience in successful grant writing.
Several years of experience in guiding graduate students and technicians.
Computer literate: Microsoft Excel, Software Program, data base, word perfect, power point
Extensive scientific presentations as invited speaker in several International Conferences.


Skills:
SUMMARY OF QUALIFICATIONS:

Managerial experience for twelve years.

Extensive experience in state-of-the-art Quality Systems and Regulatory Affairs including Quality Control and Quality Assurance, Manufacturing (upstream and downstream), Regulatory Compliance, Audit, Training and Validation.
Substantial knowledge and experience in Product development process, project and program management (evaluate, prioritize and handle) in biopharmaceuticals
Extensive experience in state-of-the-art techniques in Cell Biology, Protein Biochemistry, Molecular Genetics, Proteomics, Oncology, Microbiology, Virology and Immunology.
Strong leadership, management and organizational skills.
Strong technical skills detail oriented, efficient and work well in a team or independently.
Extensive experience in writing and review of grants, technical reports, SOPs and protocols.
Excellent communication and interpersonal skills.
Strong written and verbal communication
Highly motivated, self starter with broad biological sciences expertise
Facilitation and presentation skills
Macintosh and PC proficient


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