Dylan Lewis
Philadelphia,PA
Summary
Results-driven Technical Operations Specialist with a proven track record at Advanced Therapies, excelling in regulatory compliance and client relationship management. Skilled in authoring precise technical documentation and enhancing system performance, I effectively adapt communication styles to meet diverse client needs while ensuring adherence to industry standards.
Overview
9
9
years of professional experience
1
1
Certification
Work History
Technical Operations Specialist
Advanced Therapies
Philadelphia, PA
05.2024 - Current
- Authored and edited technical documentation for multiple manufacturing processes.
- Supported clinical pharmaceutical processes including: gene-mediated, non-gene-mediated, viral vector, and flow cytometry, and other intervention types.
- Managed diverse client expectations and adapted communication styles accordingly.
- Conducted thorough investigations of nonconforming events from initiation to closure.
- Monitored system performance, identified improvement opportunities, and provided technical guidance.
- Proactively learned about processing equipment and operational manipulations for enhanced understanding.
Technical Writer I
WuXi AppTec
Philadelphia, USA
02.2023 - 05.2024
- Authors, edits, and submits documentation for R&D and GxP analyses
- Working knowledge of industry documentation includes (but not limited to): standard operating procedures, test methods, client protocols, qualification protocols, NCEs, work instructions, and other technical documents
- Collaborates with area SMEs to better facilitate right-first-time submission for client needs
- Relays complex technical processes and procedures in a clear and concise written format and style that is easy to understand for analysts, operators, and clients
- Ensures documentation meets federal compliance for R&D and GxP processes
- Provides auxiliary support as needed for Senior Technical Writer
- Familiar with engineering standards & practices
- Analytical Development Operations
Biology Peer-Mentor Program
Rowan University
Glassboro, USA
09.2016 - 02.2018
- Tutored freshmen/transfer students in chemistry, biology, and philosophy
- Provided auxiliary peer guidance on STEM course & career choices
- Provided weekly reports to superiors to qualify efficacy of peer-mentor activities
- College of Science & Mathematics
Education
Professional Science Master’s - Scientific Writing
Temple University
Philadelphia, PA05.2023
Bachelor of Science - Biological Sciences
Rowan University
Glassboro, NJ12.2018
Skills
- Client relationship management
- Multitasking and prioritization
- Communication skills
- Team collaboration
- Adaptability and flexibility
- Deadline management
- Multitasking abilities
- Regulatory compliance (21CFR)
- Software programs: MasterControl, Viva, Microsoft Office Suite, Novatek, ELPRO, REES
Certification
- White Belt (Lean, Six Sigma), WuXi AppTec, 07/01/23
- Good Clinical Practice, National Institute on Drug Abuse Clinical Trials Network, 03/01/20
Publications
Franklin K., Gordon A., & Lewis D., Spit Spreads Death: The Influenza Pandemic of 1918-19 Exhibit at the Mütter Museum., Delawriter, 02/01/20, Winter Edition, n.p.
Ancillary Experience
- Recording Secretary, Phi Kappa Psi NJ Epsilon Chapter, Rowan University, 03/01/17, 06/01/17, Glassboro, NJ, Contributed to internal and external affairs of the Executive Council, Recorded timely and accurate minutes at all meetings
- New Member Educator, Phi Kappa Psi NJ Epsilon Chapter, Rowan University, 09/01/16, 05/01/17, Glassboro, NJ, Contributed to internal and external affairs of the Executive Council, Acclimated new members to fraternity history, values, and structure, Created thorough lesson plans and assisted new members in their completion, Augmented recordkeeping for future New Member Educators
Timeline
Technical Operations Specialist
Advanced Therapies
05.2024 - Current
Technical Writer I
WuXi AppTec
02.2023 - 05.2024
Biology Peer-Mentor Program
Rowan University
09.2016 - 02.2018
Professional Science Master’s - Scientific Writing
Temple University
Bachelor of Science - Biological Sciences
Rowan University
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