RIKKI CURTO M.S.
Weston,MA
Summary
Results-driven Manufacturing Sciences Associate III with over five years of expertise in the biotechnology sector, specializing in the transition of processes to good manufacturing practices (GMP) environments. Proven track record of effectively serving as a liaison between manufacturing sciences and senior leadership, consistently delivering high-quality outcomes in fast-paced settings. Experienced in autologous and allogenic cell therapies, demonstrating adaptability and resilience under pressure. Seeking challenging opportunities that foster professional growth and leverage scientific background.
Overview
6
6
years of professional experience
Work History
Manufacturing Sciences Associate II & III
Charles River Laboratories
11.2022 - Current
- Manufacturing Sciences Associate II, 11/2022-10/2023; Manufacturing Sciences Associate III, 10/2023-Present.
- Provides manufacturing technical support for incoming technology transfers of client manufacturing processes for cell therapies under GMP guidelines.
- Acts as project lead, ensuring MSAT deliverables are tracked and on time.
- Responsibilities include, but are not limited to, the generation of documentation supporting tech transfer and manufacturing production (Batch Production Records, SOPs, process protocols, study protocols, investigations, impact assessments, process and sterility risk assessments, etc.), knowledge transfer to the manufacturing and supporting groups, on-the-floor support for initial process runs, and involvement in process preparation, execution, and closeout of technology transfer activities.
- Assisted in both internal and external audits with clients and regulatory agencies, such as HPRA, FDA, and EMA.
Manufacturing Supervisor
Charles River Laboratories
11.2021 - 11.2022
- Oversaw five direct reports in manufacturing processes such as equipment setup and operation
- Managed personnel and process schedules
- Ensured all processes were completed according to established SOPs, cGMP guidelines, CRL Quality System, and process documents
- Reviewed Batch production records for accuracy and compliance
Manufacturing Associate I, II, & III
Cognate BioServices, Inc. | A Charles River Company
09.2019 - 11.2021
- Manufacturing Associate I, 09/2019-10/2020; Manufacturing Associate II, 10/2020-10/2021; Manufacturing Associate III, 10/2021-11/2021.
- Manufacturing Associate in the industry of GMP production of novel cellular products, including compliance with regulatory agencies and associated guidelines.
- Maintained clean room behaviors, aseptic activities, and upkeep of clean room areas.
- Led training of new and current employees to perform various duties associated with manufacturing, material support, cell culture, etc.
- Performed cell culture basics, such as production, formulation, and banking of cellular products (including GMP, GDP, and aseptic processing).
- Experience with various pieces of manufacturing equipment, such as CliniMACs Plus, Lovo, Sepax, Maxcyte, and general MFG EQ.
Education
Master of Science - BIOLOGY
UNIVERSITY OF CENTRAL OKLAHOMA
12.2018
Bachelor of Science - BIOLOGY
UNIVERSITY OF CENTRAL OKLAHOMA
12.2016
Skills
- Good documentation practices (GDP)
- Good manufacturing practices (GMP)
- Aseptic technique
- Aseptic cleanroom behavior and gowning
- Continuous improvement
- Mammalian cell culture
- Cell counting
- T cell isolation and transduction
- CAR T Cell Expansion
- Microsoft Office Proficiency
- Drafting SOPs
- Document review
- Deviation investigations
- Root cause analysis methods
- CAPA Strategy Design
- Failure mode and effects analysis (FMEA)
- Critical thinking
- Oral and written communication
- Interpersonal skills
- Independent
- Leadership
- Collaborative Team Engagement
- Time management
- Adaptability
Timeline
Manufacturing Sciences Associate II & III
Charles River Laboratories
11.2022 - Current
Manufacturing Supervisor
Charles River Laboratories
11.2021 - 11.2022
Manufacturing Associate I, II, & III
Cognate BioServices, Inc. | A Charles River Company
09.2019 - 11.2021
Master of Science - BIOLOGY
UNIVERSITY OF CENTRAL OKLAHOMA
Bachelor of Science - BIOLOGY
UNIVERSITY OF CENTRAL OKLAHOMA
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