Seasoned Quality Interim Leaders

Access Clora’s QA/QC interim leadership with gene therapy expertise to fill the gap and augment your team.

Director of Gene Therapy QC

  • About: Seasoned cGMP Biotechnology leader in QA, QC, global commercial and clinical fields. Expertise also extends to project management SME / Leadership, business process improvement lead, gene therapy, monoclonal, small molecule, device, global quality technology transfer lead, international market launch, QMS SME / PAI readiness lead, risk assessment lead, and Quality Regulatory Lead responsibilities.
  • Name: P.T.
  • Years of Experience: 25+ years
  • Location: Southeast Region
  • Product Modalities: Gene Therapy, mABs, Small Molecules, Devices
  • Therapeutic Areas: Rare diseases, Infectious diseases, Hematology
  • Previous Companies: BioMarin, Roche, and various small/mid-sized biotechs
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Head of Quality Control

  • About: Hands-on experience in (GLP, GMP & GCP), Quality, Manufacturing & Regulatory Compliance (Remediation/Certification of Manufacturing sites for SVP-TS/LVP/Aseptic), Vaccines (including Covid-19 DS/DP Manufacturing, Interim Controls & Inspection Readiness mentoring), Monoclonal manufacturing, Gene Therapy, International Audits, API Manufacturing, Technology Transfers, Compliance Training, and overseeing CMOs.
  • Name: N.T.
  • Location: California
  • Years of Experience: 20+ years
  • Product Modalities: Gene Therapy, mABs & ADCs, DNA & RNA Therapeutics, Biologics, Small Molecules
  • Therapeutic Areas: Oncology, Rare diseases, Vaccines, Infectious diseases, Immunology, Inflammation, Hematology, GI, Endocrinology, ENT
  • Previous Companies: Alexion, Fresenius, Novartis, and various small/mid-sized biotechs
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Senior Director, Quality Assurance

  • About: Seasoned Quality GxP professional committed to working with development and commercial teams to create and maintain the highest possible quality standards for investigational products. Extensive experience with GxP compliance and CMO management for the production of gene therapy, (AAV), biologics, and small-molecule from early development – labeling, packaging, supply chain, and the clinical trial setting.
  • Name: L.R.
  • Location: Greater Boston Area
  • Years of Experience: 25+ years
  • Product Modalities: Gene Therapy, Drug Delivery, Biologics, Small Molecules
  • Therapeutic Areas: Oncology, Immunology, Ophthalmology, Pulmonology / Respiratory Diseases
  • Previous Companies: Biogen, Curis, Potenza, and various small/mid-sized biotechs
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Senior Director, Quality Control and Analytical Development

  • About: An accomplished, results oriented QC and Analytical Development Leader with demonstrated success in developing analytical & QC strategy along with managing all CMC analytical activities for Biologics contributing to the development of more than 20 biologics therapeutics and vaccines. Strong technical expertise in a broad panel of analytical methodologies applicable to gene therapy products. Innovative thinker with attention to details; extensive knowledge in cGMP regulations and ICH guidelines.
  • Name: S.J.
  • Location: Greater Boston Area
  • Years of Experience: 20+ years
  • Product Modalities: Bioengineered Vaccines, Biologics, Gene Therapy, mABs & ADCs, Recombinant Products
  • Therapeutic Areas: Oncology, GI, Pulmonology / Respiratory Diseases, Vaccine
  • Previous Companies: AVEO Oncology, Batavia Bio, Pieris, and various small/mid-sized biotechs