Nicolina Lashoff (Clemente)
Ada
Summary
Results-driven scientist with proven ability to lead teams to success. Strong focus on team collaboration, operational efficiency, and achieving measurable outcomes. Adept at strategic planning, process improvement, and fostering culture of accountability and excellence. Known for adaptability and consistently meeting changing organizational needs.
Overview
7
7
years of professional experience
Work History
Manager, Technical Transfer
Fortis Life Sciences
07.2024 - Current
- Supervised multiple sets of project teams responsible for the transfer of new products and assays into manufacturing and quality control by tracking timelines, deliverables, and key performance indicators.
- Closed out fifteen design changes as part of the continuous improvement initiative for upgrading assays, refining product quality, and increasing process efficiency.
- Updated design history file (DHF) risk management procedures and FMEA forms to align with ISO14971 requirements resulting in zero audit findings in the 2024 ISO surveillance audit.
- Identified two high risk manufacturing raw materials and tested / qualified alternate vendors to reduce supply chain risk.
Interim QC Manager
Fortis Life Sciences
07.2024 - 09.2024
- Supervised four scientists and was responsible for strategic leadership activities including scheduling, setting priorities, and monitoring key performance indicators.
- Cleared out the backlog of eighteen assay validations sitting in the department for greater than three months.
- Implemented three new quality initiatives: 1) batch release, 2) line clearance, and 3) assay repeat investigations (Quality Incident Reports).
- Collaborated with manufacturing to establish a monthly quality control testing schedule to streamline material planning and reduce product delivery timelines.
Technical Transfer Senior Scientist
Fortis Life Sciences
09.2022 - 07.2024
- Supervised a group of four + scientists and was responsible for project planning, prioritization, timelines, deliverables, and inventory management.
- Remodeled design history file (DHF) procedures and forms to align with the product transfer procedure and ISO13485 resulting in zero audit findings in 2024.
- Transferred fourteen new products in 2022 - 2023 and five new products in 2023 - 2024.
- Established guidelines for expiration assignment of incoming raw materials, cleaning supplies, and internal reagents (2023).
- Identified a gap in the packaging product for shipment procedure and implemented a second person verification step resulting in a 99% reduction in product shipping complaints.
- Establishing a formal training program for design history files.
Technical Transfer Scientist IV
Fortis Life Sciences
04.2021 - 09.2022
- Implemented a new product transfer process that reduced project pass back rate by 75%.
- Designed and optimized a custom enzyme product used for early cancer detection and has yielded $1 million in company revenue.
Research Scientist III
Fortis Life Sciences
04.2020 - 04.2021
- Designed and optimized cell culture and purification procedures according to customer specifications for new enzyme products.
- Designed and optimized manufacturing procedures for a general use enzyme yielding $6.4 million in company revenue.
- Generated standard operating procedures and calculation tools for product and internal reagent manufacturing.
- Implemented an assisted training program with manufacturing personnel during project transfer.
Postdoctoral Research Fellow
Van Andel Institute
02.2018 - 09.2019
- Studied the structure and function of ion channels using Single Particle Cryo-EM and Whole Cell Patch Clamp Electrophysiology.
- Solved the first structure of a family of ion channels (CALHM) linked to Alzheimer’s disease (AD), depression, and ischemic brain damage.
- Characterized the channel’s overall architecture to understand the structure-dysfunction paradigm and how it relates to disease onset.
- Identified the binding site and inhibitory mechanism of a novel channel inhibitor which will aid in the future development of drugs that will target this family of proteins with higher specificity and potency.
Education
Ph.D. - Biochemistry / Biophysics
Rensselaer Polytechnic Institute
Troy, NY12-2017
Bachelor of Science - Biochemistry / Biophysics
Rensselaer Polytechnic Institute
Troy, NY05-2012
Skills
- Project Management and Planning
- Process Improvement
- Medical Device / Design History Files
- Team Leadership
- Policy and Procedure Development
- Risk Management and Mitigation
- Root Cause Identification
- Materials Planning
- Strategic Planning
- Technology Transfer
- Protein Purification
- Cell Culture
Timeline
Manager, Technical Transfer
Fortis Life Sciences
07.2024 - Current
Interim QC Manager
Fortis Life Sciences
07.2024 - 09.2024
Technical Transfer Senior Scientist
Fortis Life Sciences
09.2022 - 07.2024
Technical Transfer Scientist IV
Fortis Life Sciences
04.2021 - 09.2022
Research Scientist III
Fortis Life Sciences
04.2020 - 04.2021
Postdoctoral Research Fellow
Van Andel Institute
02.2018 - 09.2019
Ph.D. - Biochemistry / Biophysics
Rensselaer Polytechnic Institute
Bachelor of Science - Biochemistry / Biophysics
Rensselaer Polytechnic Institute
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