Douglas Antelman
Director Regulatory Affairs CMC at Premier Research
- Role
- Director Regulatory Affairs Cmc at Premier Research
- Location
- Corvallis, OR, US
- LinkedIn followers
- 500 followers
About Douglas Antelman
Biologics CMC Project Manager with extensive experience in Phase 1-3 + commercial development in protein therapeutics. Capable leader with strong technical background, highly skilled in strategic planning of complex projects within interdisciplinary teams. Excellent written and oral communication skills. Expertise in resource allocation, budgeting, risk assessment with significant experience in managing alliance collaborations. Broad knowledge of FDA and EMEA (USA and EU) regulatory requirements, authoring and reviewing of CMC sections for filings and responses to health authority questions. Skilled in in BLA, MAA IND and IMPD authoring. Proven record of success in taking biologics from phase 3 to BLA. Technical expertise: Analytical Method Development, method validation, technical transfer. Large molecule drug substance characterization and comparability. Immunoassay and bioassay development and validation. Host cell protein ELISA Justification of Specifications IND stability, Long term Stability Critical Quality Attributes, In-process controls
Experience
Director Regulatory Affairs Cmc
Sep 2021 — Present · Corvallis, OR, US
Regulatory CMC and CMC Dossier specialist in Biologics 25+ years Biotech industry experience
Education
University of Illinois Urbana-Champaign
Ph.D., Biochemistry
1984 — 1989
Rensselaer Polytechnic Institute
Bachelor of Science (BS), Biology, General
1979 — 1983
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