Name variants:
Eryka Skore
Last updated Apr 28, 2024
Contact Information
Last Update
Jul 12, 2022
Email
es**@amgen.com
Location
San Juan Capistrano, CA
Company
Workplace
Director Operations Pharmaceutical
Laguna Hills, CA
Industry
Medical Devices, Mfg Surgical/Medical Instruments
Colleagues
Work History
Director Operations Pharmaceutical
229 Avenida Fabricante, San Clemente, CA 92672
from May 2020
Director Drug Substance Manufacturing
10394 Pacific Center Ct, San Diego, CA 92121
Provide technical and tactical leadership for the drug substance manufacturing groups: microbial and cell culture production. Responsible for providing guidance to the manufacturing team. Le...
from Aug 2019
Director Drug Substance - Consultant
125 north Acacia Ave SUITE 101, Solana Beach, CA 92075
Manage external CDMO for company/client. Manage engineering runs and PPQ campaign. Manage technology transfers and batch records. Acting PIP/SME at external CDMO. Support NDA submission and ...
Dec 2017 — Jul 2019
Senior Manager
14282 Franklin Ave, Tustin, CA 92780
Managed the MQS project teams including QMS (deviations /CAPAs), specifications, RMS/IPMS equipment, tech transfers, and training.
Led raw material review board. Defined Class I verificati...
Sep 2016 — Oct 2017
Chief Marketing Officer Senior Manager
2642 Michelle Dr SUITE 200, Tustin, CA 92780
Managed technology transfers, operations, audits/inspections, and client liaison for large scale (100L/300L/1000L stainless bioreactor and 200L/1000L single use bioreactor) mammalian clinica...
Feb 2012 — Sep 2016
Process Development Pilot Plant Manager
1 Amgen Center Dr, Thousand Oaks, CA 91320
Managed large scale (300L fermenter, 500L/2000L stainless bioreactor and 1000L single use bioreactor) mammalian and fermentation manufacturing process. Responsible for analyzing, resolving, ...
Sep 2003 — Dec 2011
Cell Culture Manufacturing Associate Iii and Lead
225 Binney St, Cambridge, MA 02142
Operated large scale (2000L bioreactors) for commercial mammalian manufacturing. Re-designed manufacturing batch production records for commercial facility. Decreased operational errors and ...
Sep 2002 — Sep 2003
Cell Culture Manufacturing Associate Ii
Operated large scale (2000L bioreactors) for commercial mammalian manufacturing.
Started up two suites (B and C) and gained successful federal approval.
Exceeded production expectations. ...
Dec 1999 — Sep 2002
Education
2005 — 2008
1995 — 1999
Occupations
Executive
Director
Scientist
Biotechnology Professional
Operations Manager
Biologist
Biological Scientist
Skills
Biotechnology
Validation
Life Sciences
Cell Culture
Process Development
Gmp
Technology Transfer
Biopharmaceuticals
Fermentation
Monoclonal Antibodies
Cgmp
Aseptic Technique
R&D
Sop
Manufacturing
Continuous Improvement
Lean Manufacturing
Process Improvement
Product Development
Antibodies
Process Optimization
Training
Operations Management
Fda
Lifesciences
Problem Solving
Troubleshooting
Process Simulation
Aseptic Processing
Change Control
Capa
21 Cfr Part 11
Filtration
Quality System
V&V
U.s. Food and Drug Administration
Standard Operating Procedure
Verification and Validation
Quality Assurance
Deviations