Derrick Allen Email and Phone Number

Formally managed one junior analyst setting up two simultaneous development plans. The first was to develop overall career in both hard skills such as method development and soft skills like presentations. The second plan was to highlight existing qualities, such as independence, to other departments and company leaders to provide evidence for promotion to the next level at year's end. Acted as liaison for Analytical Development to all other departments in terms of study protocols and testing. This entailed a weekly and as-needed meeting to finalize action items for upcoming week's study execution. For Analytical Development, implemented an Outlook based schedule system to inform analysts of when samples should be expected, what assays would be required, and other details regarding analysis. Proposed purchase of software upgrade to Agilent ECM to OpenLab CDS. After approval, acted as Sigilon's project manager working with both Agilent and internal I.T. to provide easy installation and smooth transition for group between software configurations. Assisted troubleshooting at one of Sigilon's CMOs when system suitability continued to fail on peptide method. This included review of memoranda, meetings with CMO's project manager and quality control manager. Problem was resolved and updates to the method were approved. Change Manager for all SOPs submitted by Analytical Development in the company documentation system, Greenlight Guru.Lead on all qualification activities for Analytical Development instrumentation including scheduling of service, review of reports, and purchasing of service contracts.Reviewed all electronic notebook pages for Analytical Development. After data integrity, review focused on consistency between analysts' pages and improvements of technical writing and quality.

Implemented continuous improvement program of historical assays and standard operating procedures. As project lead, I determined experiments to determine expiration dates or mobile phases and standards and improve efficiency of methods. SOPs were reviewed for constancy, corrections, and technical voice. With the assistance of a junior analyst, updated eight methods in the first iteration of the program.Under a short timeline, developed an LCMS confirmation for residual DMSO to monitor freeze thaw excipients in storage experiments. Development explored different columns and mobile phases and close work with the engineering and cell teams for matrix effects, and simultaneously transferred to CRO . Final method was approved and incorporated into Winter 2021 toxicology manufacture. Acted as primary analyst for internal assay requestsSigilon project lead for installation of Agilent ECM database. This included purchase order and lease creation and interdepartmental work with Agilent project team and internal I.T. department for site preparation. Execution of installation and qualification was completed within 2 weeks time with minimal downtime to other department studies. Acted as system administrator through duration of time. Updated critical multi-departmental GMP toxicology study SOP to include such items as instrument qualification and logbook use, creating a subteam of two analysts I lead in quarterly logbook review. Dual improvement of critical peptide conjugation assay including improving gradient conditions without sacrificing method run time to improve peak performance of two analytes and sample prep development for acid hydrolysis utilizing microwave heating to improve turn around time of method by 33%.Reviewed junior analyst's electronic laboratory notebook pages for assay execution of samples for pH and osmolality, Acted as primary analyst for three assays and back up analyst for an additional four.

Project lead on new client oligonucleotide API molecule, including monitoring of the intermediate species. Included all client analytical development communication, weekly updates, development, limited qualification, QC lab transfer of HPLC and UPLC purity methods, and authoring of all related documentation.

On an accelerated timeline, developed and qualified a non-denaturing ion exchange HPLC purity method for the client's oligonucleotide API molecule with monitoring of specific impurities including weekly updates on development with direction for experiments and final parameters. This was in conjunction with authoring of the method with quality control department limitations in mind and authoring, executing, and documenting the protocol driven qualification of the method for release testing for phase 2/3 clinical trials. Upon submitting reports, drafted and approved validation protocol and oversaw the management of validation activities. Presented proposals to senior leadership on lab operations to allow for efficient execution of housekeeping tasks with minimal disruption to analysts' lab and client-related workloads. Executed and documented three protocol-driven IND filing forced degradation studies for the client's different API duplex oligonucleotides. Each protocol included monitoring ten different stressors and analyzing two methods for each molecule. Reports were submitted ahead of schedule. Executions resulted in department presentations on the efficient execution and high-throughput processing of protocol execution. Under the supervision of the department's senior chemist, developed non-denaturing ion exchange and denaturing ion-pairing reverse phase purity methods for client duplex molecule. The development led to limited qualification for phase-appropriate material.Authored qualification documentation and participated in installing analytical development and quality control instrumentation for client-specific methods, including Agilent HPLCs and Thermo Integrion IC and CAD detector.

Part of the QC-Methods and now Analytical Development group at Pharmalucence, a Sun Pharma Company. Chief duty was the development, validation, and transfer of analytical methods for raw material, related substances, and final product vials for both company "legacy" products and contracted products from outside labs. Instrument use primarily focused on HPLC with a diode array detector (DAD) but expanded to cover a charged aerosol detector (CAD) utilizing Agilent ChemStation and OpenLab software. All work was in compliance with FDA and ICH guidelines and cGMP, GMP, GDP, and GLP practices.Subject matter expert in optical particle sizing techniques. Primarily focused on single-particle optical sensing using an AccuSizer 780AD but accompanies methods focused on light microscopy. In conjunction with lab work, authored and revised technical reports, protocols, standard operating procedures, and methods. Included review of colleagues' reports for data accuracy, comprehension, consistency, and conciseness. Upon the resignation of the Associate Director, became the project lead for the single contract product for the company. The added responsibility included not only the transfer of four remaining methods but work with Quality Assurance and Quality Control groups to qualify the remaining instruments, authoring and reviewing transfer protocols and close out reports, and heading biweekly teleconferences between the analytical sub-team and the contract lab. Briefly took on the development of heavy metal testing for raw material and final products utilizing an Agilent 7700 ICP-MS as the company moves away from wet chemical and atomic absorption testing for metals and heads towards compliance with USP/ICH guidelines set for 2018.

Part of the screening section of the Miami-Dade Medical Examiner's Office Toxicology Lab. Analyzed biological case samples for drugs of abuse and volatiles for three types of batch samples. The first was a screening and quantitative method for the analysis of alcohols via GC-headspace paired with a flame ionization detector (FID). The second was an ELISA blood drug screen on DMX instrumentation using Neogen ELISA ktis. The third was a urine drug screen broken into three parts: an EMIT assay, salicylate spot test, and liquid liquid extraction and GC/MS analysis. All methods required rigorous quality control and assurance practices that are comparable to GMP, GLP, and GDP practices in the biotechnology and pharmaceutical industry. When case work was light, time was spent validating the lab's blood GHB quantitative method via GC/MS analysis and developing a backup method for the volatile screen and quantitative method in case of instrument downtime. More custodial duties included sample documentation into the lab's laboratory inventory management system (LIMS), preparing buffers, solutions, and tissue homogenates, disposing of medications, and generating reports based on batch results.

As a third year intern, I was charged with the development of a quantitative method for the analysis of buprenorphine and norbuprenorphine in blood on an underutilized HPLC/MS instrument. Utilizing reverse phase HPLC techniques, I was able to separate the two analytes with efficient resolution within the time restraints given by the chief toxicologist. Solid phase extraction was performed on spiked samples of bovine blood to determine any matrix effects on the analytes. Finally, the parameters of the mass spectrometer were fine tuned for an optimal ion identification profile. A second project was started during this internship for a qualitative method on the same instrument for the methadone derivative, EDDP. While my internship agreement ended before significant progress could be made regarding this method, I communicated my experimental findings to the research associates in the lab and specified a clear direction the method development should take.

Based on the techniques used and presented by the Federal Bureau of Investigation, I developed a method for the analysis of pressure sensitive adhesive packaging tapes in the trace evidence lab. One component of the method was a distinction between the adhesive and film backing components analyzed through micro-FTIR with a diamond crystal. Further analysis was done utilizing polarized light microscopy and the effects of the manufacturing process of the polypropylene tape backing. Testing resolved around limited destructive analysis for the preservation of case samples. Based on results from these methods, I worked closely with the trace evidence supervisor to author the lab's official protocol.

While a graduate student, I was also a teaching assistant for FSC 444/644: Forensic Chemical Analysis. I ran the lab component for a duel graduate/undergraduate class at Syracuse University with four graduate and nine undergraduate students. This included preparing reagents, exemplar samples, running student samples through the lab's GC/MS, and grading student lab reports. I also ran weekly and monthly maintenance on the lab's GC/MS including baking the column and cleaning the ion source. In the lecture component of the course, I ran review sessions and proctored course exams for students. In the absence of the course professor, I taught lectures on the applications of infrared spectroscopy including FTIR and FTIR-ATR and color spot test in forensic analysis.

As a first year high school teacher, I had five classes of approximately twenty students each, the majority of who were high school sophomores. Each class met once a day and had a weekly lab period. By presenting topics in a clear manner, utilizing analogies and an array of problem solving skills, I taught students general chemistry concepts at the college prep level. I made myself available both before and after school for those who had difficulty with the daily lessons or simply those that wanted to practice their skills for better understanding. During lab, safety was a high priority as was the benefit on learning through experimentation. I was offered an extension on my contract for the following school year. I unfortunately had to turn down this offer as I was returning to Syracuse University to pursue an advanced degree in forensic science.

Based on the techniques used and presented by the Federal Bureau of Investigation, I developed a method for the analysis of spray paints in the trace evidence lab. One component of the method was a distinction between the spectrophotometric properties of the paint analyzed through microspectrophotometry, specifically the reflectance spectra. Class analysis was done utilizing microchemical and microsolutbility testing. Testing resolved around limited destructive analysis for the preservation of case samples. Based on results from these methods, I worked closely with the trace evidence supervisor to author the lab's official protocol.