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 Rose Sekulovich, Ph.D. Dr. Sekulovich’s C.V.
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Summary:
- Extensive experience in R&D of biologics and therapeutics, including development of viral and bacterial vaccines, gene therapies for oncology, and protein and peptide-based therapeutic products.
- Leadership of Assay Development and Quality Control functions in small, mid-sized and large biopharmaceutical companies (including study design, method and equipment qualification and validation, product release, and stability tracking and trending).
- International Project Team experience.
Core Competencies:
- Primary areas: microbiology (emphasis in virology), immunology, bio/analytical method development to support preclinical and clinical development of vaccines and biotherapeutics.
- Development, validation, implementation and transfer of appropriate bioanalytical methods used to quantify humoral and cellular immune responses to vaccines, to determine pharmacokinetic or drug disposition parameters, and to determine relative potency, in compliance with GLP guidelines where required.
- Special expertise in development and validation of cell based bioassays for measuring relative product potency and neutralizing antibodies.
- Preparation of regulatory documents and filings: authored documents and presented scientific findings to internal project teams and global regulatory agencies (such as IND and CTD, CMC sections for NDA and BLA).
- Laboratory design and planning, implementation of GXP systems and controls.
- Design, implementation and management of commercial release and stability programs in compliance with ICH guidelines.
- Evaluation, audit, selection and management of contracted laboratory services.
- Transfer of analytical methods for the determination of purity and stability of peptide and protein formulations.
- Due diligence evaluation of in-licensing and out-licensing potential of vaccines and therapeutics.
- Collaborated extensively with biotechnology and pharmaceutical companies from Europe.
Degrees & Certifications:
- Ph.D., Microbiology and Molecular Genetics, University of California, Irvine, CA
- B.A., Biology and English/American Literature (with Honors) – Revelle College, University of California, San Diego, CA
Experience:
- Althea Technologies, Inc. (San Diego, CA): 1.5 years
- Amylin Pharmaceuticals, Inc. (San Diego, CA): 6 years
- MediGene, Inc. (San Diego, CA): 3 years
- Chiron Corporation (Emeryville, CA): 12 years
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