David Colter
Roebling,NJ
Summary
Strategic Senior Director recognized for driving productivity and achieving operational efficiency. Expertise in leadership development, operational strategy, and financial management. Proven ability to communicate effectively, solve complex problems, and adapt to changing environments, resulting in successful project execution and enhanced team collaboration.
Overview
24
24
years of professional experience
Work History
Senior Director
Syneos Health
Princeton, NJ
01.2023 - Current
- Company Overview: CRO Clinical Pharmacology and Bioanalysis.
- Leading clinical bioanalytical operations in support of preclinical and clinical product development for a wide variety of therapeutic modalities.
- Responsibilities include managing a full-service, bioanalysis department of 60 full-time investigators, supervisors, and analysts, focused on method development, validation, and sample analysis for pharmacokinetic, pharmacodynamic, biomarker, and immunogenicity studies.
- Developed and implemented strategic plans to maximize organizational efficiency, effectiveness, and profitability.
- Collaborated with executive leadership team to develop long-term objectives that would drive success.
- Analyzed financial performance metrics and identified areas for improvement.
- Recruited top talent from various sources in order to meet staffing requirements.
- Oversaw budgeting processes and ensured fiscal responsibility was maintained throughout the year.
- Analyzed customer feedback data to identify areas for improvement in service delivery.
- Oversaw strategic planning and implementation to ensure organizational goals were met.
- Implemented quality control measures to uphold company standards.
- Analyzed business performance data and forecasted business results for upper management.
Senior Director
Center for Breakthrough Medicines
King Of Prussia, PA
01.2022 - 01.2023
- Company Overview: CMC, Testing, and Analytical Services.
- CMC and functional department leader, responsible for establishing analytical strategy for client programs, and ensuring that technical project teams are established, resourced, and managed.
- Leading an analytical development organization responsible for developing, qualifying, validating, transferring, and lifecycle managing analytical methods in support of cell and gene therapy products, including AAV gene therapy vectors, lentivirus drug substance, and allogeneic and autologous CAR-T drug products.
- Evaluated training needs of employees based on job roles and responsibilities.
- Lead cross-functional teams in developing creative solutions to challenging problems.
Director
Bristol Myers Squibb
Warren, NJ
01.2019 - 01.2022
- Company Overview: CMC Cell Therapy Development and Operations.
- CMC leader and head of the Analytical Development organization, spanning both Seattle, WA, and Warren, NJ, locations.
- Responsibilities focused on three key areas: 1) Deliver on the portfolio, 2) Technical innovation, and 3) Talent development.
- Accountable for CMC strategy and analytical support for cell therapy products.
- Responsibilities include directing the development, qualification, and transfer of drug product release and stability methods for both drug substance/active ingredient (viral vector), and cryopreserved drug product.
- Establish an integrated analytical control strategy and product characterization strategy for all early and late cell therapy products.
- Drive process development support activities through routine sample testing and investigations.
- Played a leading role in the recent BLA submission and U.S. Market approval of ABECMA, the first cell therapy product for the treatment of multiple myeloma.
- Providing strategic direction and technical guidance on regulatory submissions across multiple global health authority jurisdictions.
Associate Director
Johnson & Johnson
Spring House, PA
01.2015 - 01.2019
- Company Overview: Analytical Development (Malvern, PA).
- Built and led a team of twenty-six analytical scientists focused on CMC leadership and analytical development from a broad range of large-molecule modalities.
- My organization functioned across multiple NJ and PA R&D and manufacturing sites, and was composed of three teams: 1) Method Development Team, 2) Process Analytical Support Team, and 3) Clinical QC Support Team.
- Method Development Team – The function of this team is to develop, qualify, validate, and transfer analytical test methods in support of CAR-T (CARVYKTITM) drug product release and stability.
- Process Analytical Support Team - The function of this team is to provide analytical support to the CAR-T process development, manufacturing, and final formulation/fill-finish organizations.
- Clinical QC Support Team – Established clinical QC laboratory.
Principal Scientist
J&J Janssen Biologics Research
Spring House, PA
01.2012 - 01.2015
- Managed the performance and development of five direct reports.
- Initiated and led the structure-function assay team for advancing early research programs.
- Conducted pre-portfolio POC studies for CAR-T, bispecific mAbs, and T cell redirection therapeutic platforms.
Staff Scientist
J&J Advanced Technologies & Regenerative Medicine
Raritan, NJ
01.2005 - 01.2012
- Established a stem cell research program, leading to several patent filings, clinical programs, and new technology proposals.
- Managed the performance and development of 1 FTE and multiple co-ops/visiting scientists.
- Collaborated with other researchers on projects related to molecular biology and genetics.
- Performed independent experiments to explore new scientific concepts and theories.
- Participated in interdisciplinary collaborations with other scientists from different institutions.
- Prepared presentations summarizing current research projects and results for internal stakeholders.
Postdoctoral Scientist/Adjunct Professor
Thomas Jefferson University
Philadelphia, USA
01.2001 - 01.2005
- Company Overview: Dept. of Immunology and Rheumatology
- Dept. of Immunology and Rheumatology
Postdoctoral Scientist/Adjunct Professor
Princeton University
Princeton, USA
01.2001 - 01.2005
- Company Overview: Dept. of Molecular Biology Cell Biology
- Dept. of Molecular Biology Cell Biology
Postdoctoral Scientist/Adjunct Professor
Rockefeller University
New York, USA
01.2001 - 01.2005
- Company Overview: Dept. of Cell Biology
- Dept. of Cell Biology
Postdoctoral Scientist/Adjunct Professor
Holy Family University
Philadelphia, USA
01.2001 - 01.2005
- Company Overview: Department of Biology
- Department of Biology
Education
Ph.D. - Cell and Molecular Biology
Tulane University
New Orleans, LA06.2001
B.S. - Biology
University of Portland
Portland, OR05.1996
Certificate - Clinical Trial Regulatory Affairs
Rutgers University
Skills
- Bioanalysis leadership
- Analytical strategy
- Method development and validation
- Business strategy
- P&L and budget management
- GLP/GCLP
- Project management
- Technical innovation
- Organizational development
- Cross-functional team leadership
- Budget management
- Business development
- Strategic planning
- CRO experience
- CMC leadership
- IND/BLA regulatory filing
- Business development strategies
- Cell and gene therapy
- Biomarker bioanalysis
Publications
- > 30 manuscript publications and awarded patents (available upon request)
Timeline
Senior Director
Syneos Health
01.2023 - Current
Senior Director
Center for Breakthrough Medicines
01.2022 - 01.2023
Director
Bristol Myers Squibb
01.2019 - 01.2022
Associate Director
Johnson & Johnson
01.2015 - 01.2019
Principal Scientist
J&J Janssen Biologics Research
01.2012 - 01.2015
Staff Scientist
J&J Advanced Technologies & Regenerative Medicine
01.2005 - 01.2012
Postdoctoral Scientist/Adjunct Professor
Thomas Jefferson University
01.2001 - 01.2005
Postdoctoral Scientist/Adjunct Professor
Princeton University
01.2001 - 01.2005
Postdoctoral Scientist/Adjunct Professor
Rockefeller University
01.2001 - 01.2005
Postdoctoral Scientist/Adjunct Professor
Holy Family University
01.2001 - 01.2005
Ph.D. - Cell and Molecular Biology
Tulane University
B.S. - Biology
University of Portland
Certificate - Clinical Trial Regulatory Affairs
Rutgers University
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