Yen Tran
Dallas,TX
Summary
Dedicated pharmaceutical professional with a history of meeting company goals utilizing consistent and organized practices. Skilled in working under pressure and adapting to new situations and challenges to best enhance the organizational brand.
Overview
22
22
years of professional experience
Work History
Technical Service, Senior Manager
Aytu Biopharma (formerly Neos Therapeutics Inc.)
03.2019 - Current
- Led the creation, development, and validation of electronic spreadsheets for use in the manufacturing facility
- Developed Aytu Biopharma’s standard operating procedure for Risk Assessment, Study Request, and Technical Transfer of Products
- Support, managed, and resolved notice of events (investigational events) in the manufacturing facility (including implementation of CAPAs)
- Updated and/or redesigned manufacturing batch records of Aytu commercial product line- Adzenys and Cotempla
- Designed, executed, and analyzed results of scale-up, feasibility/proof-of-concept, and optimization studies to support process improvement projects of Aytu's main product lines- Adzenys and Cotempla, which resulted in ~$500K in cost savings
- Lead person in charge of all trouble shooting issues in manufacturing
- Responsible for the creation and updates of Technical Service’s departmental operating procedures
- Evaluated and developed new technology screening/drying process to improve commercial production.
Head of Operations and Supply Chain Management
PureWine Inc.
08.2018 - 03.2019
- Managed contract manufacturing operations, technology transfer, and supply chain (inventory, distribution, and fulfillment) to meet sales projections
- Revamped the manufacturing control systems leading to reduction in manufacturing errors
- Updated regulatory and quality systems to ensure compliance with EU and FDA guidelines, and product quality respectively.
Product Development Consultant
Esoera Inc.
06.2018 - 08.2018
- Consultant work to research, formulate, and develop allergy project from ideation to commercial manufacturing plans
- Includes facility readiness, equipment planning, and quality control specifications
- Delivered five (5) prototype products for next phase consumer market testing.
Senior Scientist, Biologic Technical Development and Manufacturing (BTDM)
Alcon Laboratories, Inc. (a division of Novartis)
01.2016 - 04.2018
- Supported BTDM’s Drug Product Lead in the late phase development of two single-chain antibody fragment (scFv)) in robustness studies/DOE, clinical supply manufacturing and management, Technology Transfer to commercial site in preparation for Primary Stability and Validation batches
- Led the FMEA and QbD assessments of BTDM’s lead single-chain antibody fragment project
- Led the compatibility and primary package feasibility studies of monoclonal antibody project
- Experienced in analytical techniques such as purity Ion-Exchange Chromatography and Size Exclusion Chromatography (both for purity analysis), particulate analysis by light obscuration (HIAC) and Micro Flow Imaging (MFI), protein concentration determination by Nanodrop and Cary 300 UV-Vis, etc
- Experienced in aseptic preparation of small scale packaging components and aseptic filling of small scale batches
- Led the GMP Clinical Stability Management
- Led and managed the lab build out, equipment procurement (assessment, negotiations, quotes, and approval), installation, documentation, and compliance of instruments
- Responsible for equipment asset compliance (preventive maintenance, calibration, requalification, performance checks, and unscheduled events) and invoice/payment approvals
- Major achievement in 2017 was no missed events and out of compliance equipment
- Responsible for the integration and harmonization of document qualification practices with Novartis
- Managed inventories of lab supplies, consumables, reagents, and vendor contracts
- Led the Environmental and Health Safety team for the Biologics Product Development group
- Major achievement for the division in 2017 was zero lost day of work for the whole year.
Process Development Technical Lead, Pharmaceutical Product and Technology Development (PPTD)
Alcon Laboratories, Inc. (a division of Novartis)
02.2015 - 01.2016
- Supported the clinical supply manufacturing of Alcon’s key biologic project- RTH258 (humanized single-chain antibody fragment (scFv))
- Served as the Process Development, Global Clinical Supply Manufacturing, and Global Clinical Supply Distribution Representative in the CMC Subteams in all Alcon’s biologic projects- RTH258 and LME636
- Led for all Technology Transfer Documents
- Served as the Process Development representative for four (4) small molecule projects
- Successfully supported the clinical trials of RTH258 to meet the corporate goals of First Patient First Visit (FPFV) in 2015
- Served as the Technology Transfer coordinator with Alcon’s commercial manufacturing site in Puurs, Beligum for RTH258 for packaging presentations in vial and pre-filled syringe
- Successfully supported the initiate Technology Transfer of RTH258’s Pre-Filled Syringe Engineering Run at Alcon’s commercial site in Puurs, Belgium
- Supported investigations and deviations for all biologic related GMP processes
- Created the Pilot Facility’s Black and White Visual Inspection procedure
- Improved technology transfer of finished product from the Pilot Facility to other sites within Alcon, Fort Worth campus
- Improved the non-viable particulate monitoring process during aseptic filling in the Pilot Facility
- Successfully procure for the Process Development team a medium size steam sterilizer before the end of 2015 with no delays
- Tracked Key Performance Indicators for Process Development such as Right-The-First time product transfer from R&D to MTO (successful batches versus failed batches), Tech Transfer lead time readiness (availability of documentation at time of transfer versus delays due to unavailability of documentation), etc
- Media qualified to work in an GMP aseptic environment.
Head of Global Clinical Supply Manufacturing, Pharmaceutical Product and Technology Development (PPTD)
Alcon Laboratories, Inc. (a division of Novartis)
06.2013 - 02.2015
- Lead a team of 10 individuals in the manufacturing of sterile medicinal products in the GMP Pilot Facility
- Authored, Reviewed, and Approved Manufacturing Batch Records, SOPs, Work Instructions, Technology Transfer Documents, Validation Documents, and Regulatory Submission Documents to support both Clinical Studies and Primary Stability Batches
- Managed Media/Aseptic Programs, which includes annual media plan summary, creation and review of media manufacturing batch records assuring compliance with corporate standards, and completing documentation summarizing results
- Managed all of Alcon's Vision Care and Pharmaceutical clinical supply manufacturing needs, in addition to Primary Stability Batches
- Successfully managed and met all clinical study initiation goals and targets for Proof of Concept and Confirmatory Studies
- Led the manufacturing of Primary Stability Batches
- Led the manufacturing of over 20 projects in various stages of development and project life cycles
- Responsible for manufacturing documentation related to clinical supplies is accurate, complete and meets and regulatory requirements
- Implemented process improvement initiatives which was aimed to reduce audit observations
- Key Performance Indicator metrics such as number of batches per year, number of successful batches versus failed batches, etc
- Led strategic planning for the manufacturing of Primary Stability Batches and Clinical supplies, consistent with the pipeline strategy to ensure Global Clinical Supply Manufacturing
- In addition, identified the required capabilities to support GMP product production processes
- Served as backup to the Head of Facilities Operation for six months while serving as Head of Global Clinical Supply Manufacturing
- Media qualified to work in an GMP aseptic environment
- Successfully passed four (4) audits for the Pilot Facility, with no major observations noted.
CMC Lead, Pharmaceutical Product and Technology Development (PPTD)
Alcon Laboratories, Inc. (a division of Novartis)
08.2011 - 06.2013
- CMC Lead for the following… two NIBR (early phase) Projects which successfully moved into Proof of Concept
- Three Drug Efficacy Study Implementation (DESI) Projects
- Glaucoma project which successfully completed modeling and simulation, and formulation assessment
- Glaucoma Project which successfully received EMA approval in December 2013 and FDA approval in 2014
- Dietary Supplements Projects
- Researched alternative delivery platforms for OTC Dry Eye.
Manager, Brand Product Development
Impax Laboratories, Inc.
07.2002 - 08.2011
- Led the Clinical Supply Management of Brand Products including: Manufacturing of Clinical Supplies, (both investigation product, placebo, and comparator manufacturing), Procurement of Drug Comparator, Bottling, Packaging, Clinical Labeling, Kitting, Shipping, IVRS/IWRS Input, Warehousing, Supply Maintenance, Depot Management, Destruction and Project Close-down
- Successfully Scaled Up Batches ranging from Phase I (100 grams) to Phase III (1000 kilograms)
- Contributed to the Commercialization of Brand Product Readiness: Scale Up Equipment Assessment, New Building Planning, Process Train Development for Commercial Batches, Process Improvements to Improve Batch Yield
- Contributed to the Technology Transfer of Brand Products: Successfully supported the Technology Transfer of Impax's Lead Brand Product- IPX066 (Rytary) from Hayward, California facility to Jhunan, Taiwan facility
- Experienced in Phase I to Phase III Formulation and Process Development of Brand Products
- Board Brand Product Experience: Successfully supported the development of three (3) of Impax's Brand Products from Phase I to Phase III development- IPX054(Vadova), IPX056, and IPX066 (Rytary)
- Contributed to the NDA readiness of Impax's Lead Brand Product- IPX066 (Rytary)
- Clinical Supply Design Experience for Phase I to Phase III Clinical Trials: Fully understand the clinical supply design of clinical trials and what it takes from idealization to execution of plan
- Experienced in Clinical Trial Design from Blinded to Open Label Studies
- Management Experience: Supervised more than two Scientists, while serving as an adviser for other Senior Scientists
- Well experienced in Phase I to Phase III Clinical Studies: Approximately twenty (20) Phase I Studies, Over three (3) Phase II Studies, More than seven (7) Phase III Studies.
Education
B.S. Chemical Engineering -
University of California
Los Angeles, CASkills
- Formulation Development
- Process Development
- Laboratory Management
- Pilot Facility
- Technical Transfer
- Commercial Scale-Up
- Commercial Launch
- Global Clinical Supply Manufacturing
- Global Clinical Supply Distribution
- Good Laboratory Practices
- Quality Leadership
- Project Management
- Environmental Health & Safety
- Research
- Troubleshooting and problem resolution
- Strategic Planning
- Operations Management
- Operations Planning
- Data Analytics
- Problem-Solving
- Teamwork and Collaboration
- Continuous Improvement
- Problem-solving abilities
- Managing Operations and Efficiency
- Problem Resolution
- Adaptability and Flexibility
- Decision-Making
- Analytical Thinking
- Process Improvement
Professional Highlights
- Eleven years of experience and knowledge in the formulation and process development, including technology transfer and commercialization, of Immediate, Modified, Controlled, and Delayed-Release Formulation, and of Solid Dosage Drug Delivery Systems
- Key contributor to Impax Laboratories’ first Brand Product – Rytary, which received FDA approval in January 2015. Rytary ’s projected US revenue growth is estimated to be $275 million to $350 million by 2019 (according to the 33rd Annual J.P. Morgan Healthcare Conference)
- Seven years of experience and knowledge in formulation and process development of the Manufacturing of Sterile Medicinal Products. Achieved position as Head of Global Clinical Supply Manufacturing, responsible for all of Alcon and Novartis' Vision Care and Pharmaceutical's Clinical Supplies and Primary Stability Batches
- Experienced in late phase Biologics Product Development and Manufacturing, and Laboratory Operations
- Experienced in IND, ANDA, NDA, OTC, and DESI projects.
Specialized Training
- CfPA Educational Training: Granulation, Tablet, and Capsule Technology
- Glatt Technology: Current Practices in Control Release Technology
- Colorcon School of Coating
- CfPA Educational Training: Pilot Plant and Scale-Up Studies
- M.I.T Professional Training: Controlled Release Technology-Delivery Systems for the Pharmaceutical, Proteins, and Other Agents
- CfPIE, Aseptic Processing in the Manufacture of Biotech and Pharmaceutical Products
Awards
- Received a Neos Star Award at Neos Therapeutics for Excellent Work
- Received two (2) CEO Awards for Excellences at Impax Laboratories
- Received multiple SPOT Awards for Achievements at Impax Laboratories and Alcon Laboratories (a division of Novartis)
Timeline
Technical Service, Senior Manager
Aytu Biopharma (formerly Neos Therapeutics Inc.)
03.2019 - Current
Head of Operations and Supply Chain Management
PureWine Inc.
08.2018 - 03.2019
Product Development Consultant
Esoera Inc.
06.2018 - 08.2018
Senior Scientist, Biologic Technical Development and Manufacturing (BTDM)
Alcon Laboratories, Inc. (a division of Novartis)
01.2016 - 04.2018
Process Development Technical Lead, Pharmaceutical Product and Technology Development (PPTD)
Alcon Laboratories, Inc. (a division of Novartis)
02.2015 - 01.2016
Head of Global Clinical Supply Manufacturing, Pharmaceutical Product and Technology Development (PPTD)
Alcon Laboratories, Inc. (a division of Novartis)
06.2013 - 02.2015
CMC Lead, Pharmaceutical Product and Technology Development (PPTD)
Alcon Laboratories, Inc. (a division of Novartis)
08.2011 - 06.2013
Manager, Brand Product Development
Impax Laboratories, Inc.
07.2002 - 08.2011
B.S. Chemical Engineering -
University of California
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