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Chief Scientific Officer Resume Sample


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Chief Scientific Officer

QUALIFICATIONS PROFILE

Visionary, seasoned, and dynamic professional, offering in-depth scientific, regulatory, and clinical knowledge of developing cellular therapies in the fields of aesthetic and regenerative medicine, focused on driving corporate growth and innovation by translating goals/objectives into actionable strategies/operating plans that support the business. Possess profound understanding of stem cell biology, immunology, wound repair, cardiovascular (stroke, AMI), and inflammation. Adept at revitalizing operations and reinvigorating underperforming individuals, teams, and divisions to generate sustainable productivity gains and surpass established goals. Gain reputation as a self-starting leader who consistently drive vision toward successful completion, while implementing collaborative and large-scale initiatives that elevate staff performance, project coordination, and quality assurance. Demonstrate ability in clarifying unseen interconnectedness with big-picture vision of key projects; efficiently carry out tech transfer and management of CRO/CMO/3rd party patent matters with precision and keen attention to detail.  Technically skilled in Microsoft Office Suite and Adobe Photoshop; possess working knowledge in Japanese.

CORE COMPETENCIES

  • Executive Management (Venture-backed environment)
  • Operations Management
  • Strategic Planning
  • Budget Control
  • Staff Performance Development/Leadership
  • Clinical Development (Phase I, II)
  • CMC Development
  • GxP Compliance
  • Regulatory Compliance (Biologics)
  • GLP Pharmacology/Toxicology
  • Scale-up Manufacturing and Process Optimization
  • Intellectual Property Protection
  • Cell and Molecular Biology
  • Pathophysiology
  • Wound Repair
  • Cardiovascular Disease (Stroke, AMI)
  • Inflammation

PROFESSIONAL EXPERIENCE

SELPHYL™, Aesthetic Factors, LLC | Bethlehem, PA
SCIENTIFIC ADVISOR/CONSULTANT | 2011–Present

Author scientific publications and provide expert oversight to scientific matters. Serve as the Scientific liaison to physicians and sales force. Render efficient support to product development. Take part on Clinical Advisory board as necessarily.

Garnet BioTherapeutics, Inc. |  Malvern, PA
CHIEF SCIENTIFIC OFFICER/ SENIOR VICE PRESIDENT, Technology Department & IP Management | 2008–2010

Cultivated professional relationships with CMO, CRO and KOLs. Lead cross-functional teams responsible for product development, scale-up manufacturing, supply-chain management, and GxP compliance. Developed and implemented scientific vision for the company/shareholders. Worked collaboratively with new executive management, board of directors, consultants, and outside thought leaders to shape clinical and regulatory strategy/direction of the company. Maintained strict confidentiality of company inventions/trade secrets; constructed patent strategies; conducted survey for patent landscape of competing art; and administered 3rd party patent counsel activities related to all patent matters.

Career Highlights:

  • Simultaneously finalized IND-enabling pre-clinical pharmacology and toxicology studies, filed IND, and introduced clinical trial NCT01053897 for treatment of incisional wounds
  • Lead cross-functional team that developed novel method for cell therapy administration, which was subsequently implemented for clinical purposes
  • Lead cross-functional team consisting of process development, manufacturing, clinical development and regulatory to develop novel method for scale-up manufacture of mammalian cells
  • Reassigned GMP manufacturing and testing methods to 3rd party contractor within a short period of time
  • Lead cross functional team (CR&D, manufacturing, QA, and Regulatory) in conceptualizing/, developing, and successfully implementing a GMP-grade medical device for use in treating soft tissue injuries
  • Partnered with outside counsel in filing multiple provisional patent applications, as well as several other patent applications, appeared at national stage in more than 40 countries, and accomplished several freedom-to-operate analyses, numerous other rebuttals, and declarations
  • Lead cross functional team (R&D, Manufacturing and Quality Assurance) in the development and execution of an equine cell therapy program/product as well a product release/stability program and specifications
  • Lead CR&D team in execution of three cadaveric studies to test feasibility of medical device (2 human hand studies) and ultrasound-guided injection of equine cells (1 equine flexor tendon study)
  • Led overall implementation of a GMP suite by supervising the coordination, validation, staffing, and SOP’s generation; met the requirements of the suite and staff for manufacturing; then subsequently produced several lots of GMP products

Neuronyx, Inc. | Malvern, PA
VICE PRESIDENT, Technology Department & IP Management | 2007–2008

Conceptualized and developed operating/strategic plans regarding clinical development, manufacturing, process development, research, and IP matters. Handled and provided resolutions to all patent matters through initiation and execution of new technology initiatives. Fostered close communication with technical experts, industry thought leaders, and academic collaborators to support new clinical direction of product development. Completed and closed out Phase clinical trial NCT00361855.

Career Highlights:

  • Strategically constructed cost-effective plan to decrease operating costs and elevate flexibility/productivity through remarkable outsourcing efforts
  • Hired quality assurance consultant to assist in closing out internal GMP operations while maintaining/ensuring regulatory/quality compliance
  • Managed collaborative efforts to evaluate 3rd party CMO for outsource manufacture and testing/storage of lead product, GBT009, as well as other critical cell banks
  • Coordinated third party due diligence with specialty pharmaceutical company interested in partnering technology

Neuronyx, Inc. | Malvern, PA
SENIOR DIRECTOR, Technology Department | 2007

Pioneered new technologies in preparation for the next-generation biopharmaceuticals. Sourced and implemented ways to improve product manufacturing while maintaining minimal cost of goods.

Career Highlights:

  • Played substantial role in filing four patent applications, boosting company reputation at the marketplace
  • Identified methods for developing new product prototypes
  • Built relationships with collaborators/area experts to support clinical rationale for use of lead product, GBT009 in dermal indication

Neuronyx, Inc. | Malvern, PA
SENIOR SCIENTIST | 2003–2007

Created strategic CR&D objectives and implemented operating plans to drive overall company growth. Supervised high-caliber projects that optimized product and process development while addressing/satisfying key regulatory questions around CMC. Developed new clinical program opportunities by devising a regulatory strategy leveraging company’s pre-clinical and clinical portfolio. Oversaw core projects through product characterization and MOA. Supervised the IND-enabling pre-clinical research based from key academic collaborations and contract research organizations. Grew and managed intellectual property portfolio.

Career Highlights:

  • Provided expert oversight to the Cardiovascular Team in compiling IND and submitting and clearing Phase I clinical Trial in Sub-Acute Myocardial Infarction (NCT00361855)
  • Developed and implemented various pharmacology and toxicology studies that strengthened stroke clinical development

Neuronyx, Inc. | Malvern, PA
SCIENTIST | 2000–2003

Constructed an in-house spinal cord injury (SCI) program to study therapeutic potential of cell prototypes. Initiated and executed in vitro and in vivo projects based on cell differentiation, characterization, and manufacture, as well as pre-clinical development of cell prototypes. Supervised overall recruitment and training of key positions for R&D and early phase-manufacturing. Established and maintained IND-enabling pre-clinical research/relationships through development of major academic collaborations and contract laboratory.

Career Highlights:

  • Invented a scale-up platform for GMP isolation and ex vivo expansion of various human stem cells and somatic cells
  • Isolated, characterized first cell prototype which would eventually become company’s core technology and product
  • Displayed unsurpassed leadership to nearly all pre-clinical SCI team to expedite the completion of more than 11 pre-clinical studies supporting path to IND in less than two years
  • Conducted thorough analysis of multiple pre-clinical studies, formulated SOPs for surgical, and LAF procedures, educated personnel on Keck Center model of spinal cord contusion with BBB, and directed staff of approximately 10 scientists/research associates
  • Leveraged solid writing and presentation skills in writing manuscripts in support of various projects

EARLIER CAREER

Drexel College of Medicine [Formerly Medical College of Pennsylvania and Hahnemann University (MCPHU)] | Philadelphia, PA
POSTDOCTORAL FELLOW, Center for Gene Therapy
GRADUATE STUDENT, Doctoral Program Molecular Pathobiology

Medical College of Pennsylvania | Philadelphia, PA
CLINICAL LABORATORY MANAGER, Department of Pathology
RESEARCH ASSOCIATE, Laboratory of James England, MD., Ph.D. (Part-Time)

Hospital of the University of Pennsylvania, OB-GYN | Philadelphia, PA
STUDENT VOLUNTEER, Labor and Delivery (Part-Time)

Medical College of Pennsylvania, Department of Pathology | Philadelphia, PA
RESEARCH ASSOCIATE, Laboratory of James England, MD., Ph.D. (Full-Time)

Eastern Pennsylvania Psychiatric Institute | Philadelphia, PA
PSYCHIATRIC TECHNICIAN (Full-Time)

Eastern Telephone Systems | Fort Washington, PA
SALES AND MARKETING REPRESENTATIVE (Full-Time)

Kidder, Peabody & Co. | Tampa, FL
INTERNSHIP, Brokerage and Client Services

EDUCATION AND PROFESSIONAL DEVELOPMENT

DOCTOR OF PHILOSOPHY IN MOLECULAR PATHOBIOLOGY
Drexel College of Medicine [Formerly Medical College of Pennsylvania and Hahnemann University (MCPHU)] ▪ Philadelphia, PA

BACHELOR OF ARTS IN SOCIOLOGY
University of South Florida, College of Social and Behavioral Sciences ▪ Tampa, FL

  • Good Clinical Practice Training, Malvern Consulting Group ▪ 2010
  • Dermatological Product Development ▪ 2006
  • GxP Training, Knotts, and Associates ▪ 2001, 2005, 2008, 2010
  • W. M. Keck Center for Collaborative Neuroscience, SCI Research Models ▪ 2000

AFFILIATIONS

American Stroke Association (ASA) ▪ Wound Healing Society (WHS) ▪ American Spinal Cord Injury Association (ASIA) ▪ International Society for Stem Cell Research (ISSCR) ▪ Hot Topics Committee, Pennsylvania Bio

COMMUNITY INVOLVEMENT

Little Sisters of the Poor
Supported development efforts to fulfill organizational objectives

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