Martin Powell Email & Phone Number

Washington, Dc, Us

Rockville, Maryland, Us

Provided technical oversight on external commercial manufacturing activities including scale-up and technology transfer to CMOs. Supported solid dose and liquid pharmaceutical products Qelbree, Trokendi XR, Oxtellar XR, Xadago, and Gocovri. Myobloc biologic. Proposed and led continuous improvement projects at CMOs. Conducted manufacturing investigations and performed root cause analysis for pharmaceutical manufacturing investigations. Reviewed Change Controls, CAPAs, and complaints.Strong leadership and technical abilities. Adept at problem-solving in a fast-paced environment.Reviewed batch records and batch data.Tracked and trended pharmaceutical manufacturing data with statistical software JMP.Strong knowledge of biotech/pharmaceutical manufacturing operations. Granulation, Encapsulation, Compression, Fluid Bed Coating, Milling, and Mixing.Prepared and wrote documents for regulatory submissions. Assisted in the preparation of regulatory filings.Managed clinical labeling and packaging.Proficient in the scale-up, transfer, and validation of pharmaceutical manufacturing processes,

Rockville, Maryland, Us

Performed a wide variety of tasks in the Drug Delivery Sciences department including designing and conducting lab scale formulation experiments, manufacturing GMP clinical supplies, participating in the technical transfer / scale-up activities of drug product formulations and processes to CMOs, writing equipment SOPs and technical reports, and writing CMC sections for the US and ex-US regulatory filings. Conducted lab scale formulations experiments to develop solid dose oral formulations.21 CFR 82021 CFR Part 4ISO 14971

Developed both spray dryer and fluid bed equipment configurations and test designs. Performed tests for customers to showcase the wide range of capabilities of the company's equipment. Worked with the team during test runs to ensure that optimum results were achieved. Generated technical reports and presented the information to colleagues and customers. Collected and interpreted test data. Executed detailed process outlines. Organized test materials.Traveled to customer sites to conduct process studies.

Us

Designed and developed formulations using either company's technologies or applicable standard pharmaceutical techniques. Developed and executed a plan of action to solve product related technical issues and preventive actions to avoid recurrence. Developed and executed formulation development strategy for R&D and registration of new products with input from management. Influenced process development approaches and evaluated their course across a range of different project types. Developed formulation project plans including timelines for review by department management. Communicated timelines of project plans to CMC Project Team. Implemented plans, tracked accomplishments verus commitments, and informed management and CMC teams when objectives are achieved and when setbacks are encountered. Worked with management to develop strategic options for process development and resolution of issues. Interfaced with other technical staff to design and perform experiments and provided interpretation of data in support of product development activities. Wrote development reports to support regulatory filing of products. Complied with all regulatory requirements that applied to drug development and manufacture.Experience operating and troubleshooting the following equipment: Courtoy, Killian, & Fette Tablet PressesO'Hara Labcoat I,II, and III Pan CoatersGlatt 3, 5, & 60 Fluid Bed2, 5, 10, & 20 cu. ft. V-BlendersRoll CompactorsHigh Shear GranulatorsFitzmill D6AKlockner CP2 Blister Packaging

Bristol, Tn, Us

Manufactured both clinical and developmental solid dosage forms under cGMP for clients. Set-up and operated blenders, fluid beds, tablet presses, and pan coaters. Analyzed physical properties of active pharmaceutical ingredients. Performed tablet dissolution studies. Lyophilized proteins. Shipped finished product to clients. Key Accomplishments* Formulated Vitamin C tablets ensuring client specifications were met. * Maintained client satisfaction and met aggressive deadlines.