David Trinkle Email & Phone Number

New Brunswick, New Jersey, United States

𝗥𝗲𝘀𝗽𝗼𝗻𝘀𝗶𝗯𝗶𝗹𝗶𝘁𝘆: Advanced the portfolio and pipeline as a technical leader and SME in powder properties and processing. 𝗔𝗰𝘁𝗶𝗼𝗻𝘀 𝗮𝗻𝗱 𝗜𝗺𝗽𝗮𝗰𝘁: • Led and initiated a lessons learned and continuous improvement plan that solved a long-standing vendor performance gap in instrument maintenance, performance verification, and documentation. • Implemented a quality by design (QbD) method that provided scientific rigor, assured downstream manufacturing success, and assured product critical quality attributes (CQA). • Identified a need to expand usage of OSD Lab Automation. Proposed a strategic plan, gained approval, and conducted multiple knowledge sharing sessions that created a learning environment. Resulted in the execution of more studies and workflows that enabled flexibility and speed driving the pipeline. • When a product with difficult physical properties created an impasse, responded with a strategic plan to address manufacturing challenges. Conducted machine trials, characterized the powder-filling processes, evaluated the technologies, and assessed risks. Project management resulted in proof of concept for a prototype container design, leading to a final design that enabled drug product development to continue. • An unused automation system was identified as valuable following the acquisition of a new facility. Provided guidance on recommissioning and identified critical workflows. These actions resulted in a new capability, which benefited formulation ingredient decisions and drove the development of the pipeline. • Strategically designed experiments, executed plans including data analyses, and formed conclusions. Presented recommendations to teams on the high-shear wet granulation process risks, including tablet compression factors and API flow risk, using a novel mini-piloting method and MIP analysis of granule PoSD and granule porosity. Results drove drug product development.

New Brunswick, New Jersey, United States

𝗥𝗲𝘀𝗽𝗼𝗻𝘀𝗶𝗯𝗶𝗹𝗶𝘁𝘆: Advanced the pipeline as an innovation leader in mini-piloting and SME in powder properties and processing. 𝗔𝗰𝘁𝗶𝗼𝗻𝘀 𝗮𝗻𝗱 𝗜𝗺𝗽𝗮𝗰𝘁: • When a spray-dried intermediate critical quality attribute (CQA) and flowability acceptance criteria had to be identified, utilized novel API flow test methodology to discriminate flowability among a range of DoE samples. Established new manufacturing process parameters, thereby driving organizational goals. • Conceptualized an innovative roller compaction scale-up method that resulted in smooth technology transfer to key contract manufacturing organizations (CMOs) and enabled the manufacturing of batches. • Conducted formulation risk assessments for tablet compaction using a constitutive model and empirical data with in depth-knowledge. By providing recommendations for formulation selection, drove pipeline projects through drug development, optimization, and commercialization of high-quality drug products. • Served as departmental safety representative, acting as a safety champion, providing guidance to colleagues, conducting safety audits, and presenting at quarterly Town Halls. Strong communication resulted in the organization meeting the acceptance criteria of no less than 95% rating.

New Brunswick, New Jersey, United States

𝗦𝗶𝘁𝘂𝗮𝘁𝗶𝗼𝗻 𝗮𝗻𝗱 𝗥𝗲𝘀𝗽𝗼𝗻𝘀𝗶𝗯𝗶𝗹𝗶𝘁𝘆: Requested to join the newly established group—Engineering Technologies—that was implemented to advance the development of high-quality oral solid dosage forms. 𝗔𝗰𝘁𝗶𝗼𝗻𝘀 𝗮𝗻𝗱 𝗜𝗺𝗽𝗮𝗰𝘁: • Recognized as a scientist who demonstrated ability to be innovative, passionate, and self-motivated. Excelled at learning process operations and troubleshooting/solving technical problems. Demonstrated ingenuity to identify, develop, and implement process engineering solutions to advance portfolio. • Introduced a multiple comparison method that provided a new way to evaluate data from API-excipient compatibility studies. Provided an efficient method to determine risks and recommend excipient options. • Conceptualized, developed, and implemented a novel resource-sparing API flow test and data analysis model. Resulted in process optimization, formulations risk assessments, and driving pipeline projects. • Conducted formulation risk assessments for tablet compaction using the modified Drucker–Prager Cap constitutive model and empirical data with in depth-knowledge. By providing recommendations for formulation selection, drove pipeline projects through drug development, optimization, and commercialization of high-quality drug products. • Gained knowledge of OSD lab automation system. Optimized workflows for API-excipient compatibility studies. Results informed formulators on degradation risks and drove drug product development. • Learned SAS JMP with coaching to advance statistical analysis capability. Applied knowledge to glean relationship between critical process parameters and product critical quality attributes.

New Brunswick, New Jersey, United States

𝗥𝗲𝘀𝗽𝗼𝗻𝘀𝗶𝗯𝗶𝗹𝗶𝘁𝘆: Formulator contributing to the drug product portfolio, supporting cross-functional teams, and collaborating across the organization matrix to advance drug product development pipeline. 𝗔𝗰𝘁𝗶𝗼𝗻𝘀 𝗮𝗻𝗱 𝗜𝗺𝗽𝗮𝗰𝘁: • Recognized by the Group Director for excellence in formulations of extended-release triple FDC bilayer tablets, cross-functional collaboration, and authoring drug product development reports. • Provided oversight of clinical supply manufacturing of drug products ensuring compliance with GMP policies, procedures, and documentation, as well as activities at external manufacturing facilities. • Following identification of a compliance deviation regarding desiccant use in drug product storage drums, deployed Kepner-Tregoe Root Cause Analysis (RCA) and created a Corrective / Preventive Action (CAPA) that resolved the deviation, provided clarity on technology transfer, and enhanced drug product quality. • Drove optimal formulation of a pediatric powder drug product for HIV treatment. Included human factor studies, hazard evaluation, Failure Modes and Effects Analysis (FMEA), and process validation. • Met key regulatory filing requirements by authoring study plans, drug product development reports, batch records, specifications, and electronic laboratory notebook (ELN) entries. • Addressed a critical analytical methods gap by proposing, initiating, and leading a Mercury Intrusion Porosimetry (MIP) superuser team, accelerating drug development and ensuring manufacturing quality.

New Brunswick, New Jersey, United States

𝗥𝗲𝘀𝗽𝗼𝗻𝘀𝗶𝗯𝗶𝗹𝗶𝘁𝘆: Support formulators and conduct experiments. 𝗔𝗰𝘁𝗶𝗼𝗻𝘀 𝗮𝗻𝗱 𝗜𝗺𝗽𝗮𝗰𝘁: • Exceeded expectations when became the MIP subject matter expert and managed complex assignments. • Recognized by Director, CSO, and Associate Director, OPD, for expeditious learning of the two most complex equipment operations and for excellence in process understanding. Drove development. • Independently conducted experiments providing high-quality deliverables. • Demonstrated interpersonal communication skills by developing rapport with scientists, technicians, and others external to group.

Hopewell, New Jersey, United States

𝗥𝗲𝘀𝗽𝗼𝗻𝘀𝗶𝗯𝗶𝗹𝗶𝘁𝘆: Supported small molecule discovery and therapeutic protein pilot plant operations. 𝗔𝗰𝘁𝗶𝗼𝗻𝘀 𝗮𝗻𝗱 𝗜𝗺𝗽𝗮𝗰𝘁: • Innovated new methods to evaluate reagent inventory compliance and verify HPLC mobile phase quality.

Piscataway, New Jersey, United States

𝗥𝗲𝘀𝗽𝗼𝗻𝘀𝗶𝗯𝗶𝗹𝗶𝘁𝘆: Conduct powder rheology and powder flow experiments using hoppers, tumble blenders, and novel apparatus—Gravitational Displacement Rheometer (i.e., an avalanching tester). 𝗔𝗰𝘁𝗶𝗼𝗻𝘀 𝗮𝗻𝗱 𝗜𝗺𝗽𝗮𝗰𝘁: • Analyzed amplitude versus shear rate to interpret flowability and cohesiveness to form conclusions. • Fabricated a modified a Taylor–Couette apparatus to determine the cause of instability of Taylor vortices, contributing to “A Taylor Vortex Analogy in Granular Flows” published in Nature (2004). 𝗔𝗱𝘃𝗶𝘀𝗼𝗿: Professor Dr Fernando Muzzio

Master Of Engineering - Meng, Pharmaceutical Engineering And Science

• 𝗧𝗵𝗲𝘀𝗶𝘀: Special Problems of Bi-layer Tablets: A Review and Critical Analysis of the Methodology to Develop and Manufacture.

Bachelor Of Science - Bs, Chemical Engineering

Activities and Societies: AIChE student chapter • 𝗔𝘂𝘁𝗵𝗼𝗿𝗲𝗱 𝗮𝗻𝗱 𝗣𝗿𝗲𝘀𝗲𝗻𝘁𝗲𝗱 𝗥𝗲𝘀𝗲𝗮𝗿𝗰𝗵 𝗣𝗼𝘀𝘁𝗲𝗿: Investigation of the effect of humidity on axial.

Associate Of Arts - Aa, Engineering

Activities and Societies: : • Writing Tutor, Volunteer (2 semesters) • Assistant to Students with Disabilities, Volunteer (2 semesters) •.