Derek Smith Email & Phone Number

Boston, Ma, Us

Cambridge, Massachusetts, United States

Lead, GMP Operations, Cell Therapy (March 2023 - Current)• Managing 3 direct reports on the manufacturing team; onboarding, training, and assisting in career development opportunities for each direct report.• Scheduling team members for GMP facility activities (EMPQ, APS, etc.) and clinical production runs.• Continuing tech transfer support for MSAT team on new projects; developing both paper and electronic batch records, training team members on new processes, and liaising between teams to ensure timelines are met. Senior Cell Processing Specialist, GMP Operations, Cell Therapy (December 2021 - March 2023)• Implemented PAS-X MES system at CTMF; primarily I developed and validated the electronic batch records for production and trained team members; I also contributed to roles and responsibilities set-up, master data configuration, and printer/label configuration.• Operated, verified, and supported tech transfer activities. Developed batch records for additional processes and standard operating procedures for new equipment.• Trained new team members on manufacturing equipment and processes. • Owned and closed process and facility related deviations, CAPAs, and Change Controls.Cell Therapy Processing Specialist I, GMP Operations (June 2020 - December 2021)• Operated, verified, and supported activities for engineering and production runs of clinical material in a grade A/B cleanroom environment. • Created and revised production batch records, standard operating procedures, job aids, and on-the-job training forms.• Performed activities in support of GMP facility qualification, including, but not limited to: environmental monitoring performance qualification, equipment qualification and validation, and aseptic process validation.• Evaluated and implemented new technology initiatives for CTMF digital transformation project such as VR training and RealWear headsets.

Greater Boston Area

Tutoring 2nd and 3rd year chemical engineering students.

Greater Boston Area

• Supported clinical operations for a variety of programs, including lentiviral vector and CAR T-cell immunology projects. • Liaised between the various teams at bluebird to lead process improvement activities and projects.• Created process flow diagrams for manufacturing processes in support of continuous improvement efforts and day-to-day operations.• Supported a value stream mapping exercise in an effort to reduce cost of goods, optimize cycle time, and increase yield using Lean Engineering and Six Sigma principles. • Worked with external contract manufacturing organizations to execute action items, escalate internal concerns, and communicate business needs. • Performed data entry, data verification, batch record review, and deviation assessments for clinical programs.

Coordinate communication over the PA system at hockey and basketball events. Assist in organizing events and activities before, during, and after events in the athletics department.

Greater Boston Area

• Supported clinical manufacturing operations for an AAV5 gene therapy company. • Assisted in the onboarding of new equipment from both a documentation and technical perspective, including the calibration, maintenance, troubleshooting, and support of qualification of such equipment. • Developed and executed engineering protocols in support of various department needs, including: temperature mapping of cryogenic storage units, drug product shipping supporting packaging qualification. • Familiarized with the process and relevant equipment used in the production of gene therapy products, including upstream and downstream processes, filling, packaging, and shipping. • Created and edited P&IDs for various systems throughout the facility. • Communicated and set up meetings with vendors for new equipment or contracting services. • Utilized GDP with quality systems such as change controls, corrective actions/preventative actions, and deviations, and facilitated communication between departments to see tasks through to completion. • Responded to and documented alarms throughout the manufacturing facility.

• Conducted pre-formulation evaluations including API and excipient solubility; bulk powder physical characterization; solvent compatibility; and excipient compatibility using a variety of analytical techniques. • Planned and executed spray drying, filling, and packaging evaluations to optimize the performance and stability of pulmonary dry powder aerosols engineered using Acorda’s proprietary ARCUSTM technology. • Executed powder characterization tests such as ACI-3 and densitometry. • Coordinated non-clinical material production activities. • Liaised with the Engineering and Manufacturing teams to evaluate process optimization and scalability of NIRO PSD-1 spray drying operations, capsule filling operations, and packaging operations.

Bachelor’S Degree, Chemical Engineering

Activities and Societies: Honors Program, Special Olympics Club, International Society of Pharmaceutical Engineers

High School

Activities and Societies: Advanced Science Research Club, National Honor Society, Spanish Honor Society, Habitat for Humanity