Adam Denney
- Role
- Manufacturing Operations Manager at Bristol Myers Squibb
- Location
- Redmond, WA, US
- LinkedIn followers
- 500 followers
About Adam Denney
I am a biotechnology professional with over 15 years of experience, including 7 years…
Experience
Manufacturing Operations Manager
May 2020 — Present
Responsible for leading and mentoring a team in a cGMP environment to manufacture patient specific cell therapies. Guide staff through multiple changes, including mergers & acquisitions, departmental reorganizations and regulatory health inspections. • Responsible for managing approximately manufacturing personnel (direct and indirect reports) across multiple shifts for 24/7/365 operations. • Enjoys coaching peers and sharing knowledge obtained from previous experiences. • Project team lead for driving key objectives of cleanroom layout modifications and LN2 cell therapy drug product storage freezer expansion to obtain and sustain plant capacity. • Development and implementation of key business deliverables for manufacturing and shipping of product intermediates used for critical vector potency testing release assay. • Utilization of cleanroom area/facility controls and study data to implement new business process to reduce facility downtime, saving approximately 1280 hours of stagnant manpower per year. • Development of Pre-PLI procedures and electronic record systems for commercial product label application, controls, storage, packaging and shipping operations. • Developed and implemented new manufacturing functional group KPIs, metrics, SQDPC boards and goals. • Aid in creating team environments where everyone thrives on collective input (no single point decision making) at supervisor/shop floor level. • Developed and implemented new cryopreserved equipment and hardware for LN2 drug product storage freezers. • Key player for developing procedures and processes for off-site LN2 cell therapy product shipments and storage.
Skills
- Western Blotting
- Validation
- Protein Purification
- Formulation
- Chromatography
- Agarose Gel Electrophoresis
- Cell Culture
- Aseptic Technique
- Manufacturing Processes
- 21 Cfr Part 11
- Component Prep
- Biopharmaceuticals
- Fda
- Technology Transfer
- Dna Analysis
- Fermentation
- Large & Small Scale
- Protein Chemistry
- Filtration
- Lims
- Gel Electrophoresis
- Dna Extraction
- Quality System
- Gmp
- Elisa
- Aseptic Processing
- R&D
- Molecular Biology
- Biochemistry
- Cleaning Validation
- Biotechnology
- Lyophilization
- Capa
- Purification
- Quality Control Microbiology
- Electrophoresis
- Cell
- Change Control
- Microbiology
- Glp
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