Steve Doares

About Steve Doares

Experienced professional in biotechnology process development, technology transfer into manufacturing, and process support/lifecycle management. Most of career focus has been biological drug substance development and production - clinical materials through commercialization. Modalities have included prophylactic molecules (pneumococcal and meningococcal glycoconjugate vaccines; blood clotting factor fusion proteins) as well as therapeutic biologicals (interferon beta-1a and its pegylated form, numerous mAbs). Production scales have ranged from 200L pilot scale fermentation/recovery to fixed bioreactor trains, and include a (bioreactor) disposable technologies facility. Functions worked in include process development, operations quality assurance, and manufacturing sciences. Most recently I have taken on leadership of Biogen\'s Global Manufacturing Sciences team, whose remit includes tech transfer and process support not just for biologics DS, but also for parenteral DP, and small molecule API and DP, as well as providing expertise in Process Analytics/Advanced Modeling/PAT, and Materials Science (raw materials and consumables - characterization testing, process impact understanding, and extractables/leachables testing for SUS).

Experience

1. SVP & Site Head, Us Manufacturing

   Cellectis

   Jul 2020 — Present · Raleigh, NC, US

   Lead a dynamic, motivated team of experienced cell therapy and biotech professionals at Cellectis\' new state-of-the-art GMP manufacturing site to produce \"off-the-shelf\" allogeneic CAR-T cell therapy Drug Substance and Drug Product. Our Manufacturing, QA/QC, Supply Chain/Warehouse, MS & T, Engineering & Facilities, EHS, Human Resources, and Finance & Accounting groups are laser-focused on turning the promise of Cellectis\' innovative programs in blood and myeloid cancer targets, using the company\'s proprietary technologies in gene editing and electroporation, into UCART (Universal CAR-T cells) drug products that can help patients with unmet needs in battling these cancers.

Education

• The University of Georgia

  Ph.D., Biochemistry

  1985 — 1990

• The University of North Carolina at Chapel Hill

  B.S. with highest honors, Botany, emphasis in Chemistry

  1978 — 1982

• University of Colorado Boulder

  ABD, Chemistry

  1982 — 1985

Skills

• Fermentation
• Process Simulation
• Validation
• Biotechnology
• Biochemistry
• Technology Transfer
• Chemistry
• Quality Assurance
• Gmp
• Cleaning Validation
• Purification
• Vaccines