Gareth Evans Email & Phone Number

Boston, Ma, Us

San Diego, California, Us

Supported Turnstone Biologics' TIDAL-01, an autologous cell therapy program, across STARLING, MCC21707, and MCC23098 clinical trials. Managed clinical manufacturing raw material lifecycle: Evaluated materials for GMP feasibility, assessed risks to supply continuity, modeled planned enrollment to predict demand, coordinated testing and quality-impacting decisions with cross-functional teams (QC/QA/MFG), and maintained inventory to achieve 100% on-time manufacturing readiness. Progressed strategic sourcing initiatives for clinical materials: Conducted market research and developed RFI processes to evaluate and select reliable suppliers. Worked cross-functionally to define sourcing requirements, led vendor evaluations, and successfully secured critical materials to de-risk Phase II readiness. Led a team focused on operational improvements associated with the end-to-end process for peptide intermediates: Evaluated options to reduce turnaround times, addressed root causes behind logistics delays and temperature excursions during shipment, improved bioinformatics workflows, identified process improvements to improve product purity, and ensured regulatory commitments were being followed through. Created and maintained the "Patient Journey Tracker", a platform built using Smartsheet and Python SDK to enable end-to-end visibility into patient progress throughout the cell therapy process. Utilized by >35% of Turnstone staff, it had led to identification of a 5-day reduction in vein-to-vein time and facilitated a >90% on-time task completion rate for clinical activities. Owned and maintained in-house data management system: Collaborated with Tech Ops teams to define user requirements for capturing, structuring, and analyzing CMC data in real time. Developed scripts for new features and managed a team of 3 contract developers to enhance functionality, ensuring robust data management across clinical operations.

San Diego, California, Us

Supported cGMP production of a Phase I/IIa, vaccinia-based, oncolytic virus.- Oversaw and sustained critical relationships with GMP material vendors. Discussed experimental findings with internal and external process development teams to evaluate current challenges, then developed product specifications, researched market trends, assessed process fit for new single-use components, and attended trade shows to initiate relationships with vendors and discover new products. Identified and implemented over ten solutions to overcome otherwise irreconcilable issues related to unavailable primary materials, unacceptable aseptic risk, and unexpected process performance.- Applied knowledge as process SME: developed production process BOM and exhibited material and equipment feasibility within process to cross-functional stakeholders (QA, regulatory, QC) via risk assessments, detailed reviews of critical quality attributes, and presentations. Able to recognize and prevent at least three compliance issues. - Owned receiving side of tech transfer from process development team. Successfully educated new CMO operators with limited prior experience of aseptic processing, supported development, reviewed, and approved full set of master batch records, executed batch records, deviations, investigation reports, and other documents as part of tech transfer activities. Efforts enabled a fully documented, executable production process for oncolytic virus product.

Indianapolis, Indiana, Us

Provided technical engineering and project management support to client Manufacturing Operations and broader Technical Operations groups during development and launch of a new oncolytic viral therapeutic production process revision. Remotely collaborated with client teams, CMOs, CDMOs, and vendors distributed across North America and Europe. Responsible for procurement of process equipment and materials: evaluated process, facility, and utility fit; represented client in vendor discussions and communications; and balanced timeline, budget constraints, and risk assessment outputs to present and enable decisions among cross-functional, internal team. Created, managed, and communicated outputs of COGS analysis, procurement schedule hinged on clinical development plan, and risk dashboard

Indianapolis, Indiana, Us

Indianapolis, Indiana, Us

Supported Waltham-based cell therapy clinical manufacturing facility retrofit activities as a project manager. Set up and maintained an integrated, resource loaded Microsoft Project schedule spanning all work streams impacting operational readiness. Tracked and communicated project risks via a risk register of schedule, cost, and personnel risks. Monitored KPIs, developed RACI matrix across several contract teams, and improved efficiency with remote-working tools shared across teams.

Indianapolis, Indiana, Us

Developed and executed commissioning protocols for greenfield, siRNA-based therapeutic manufacturing facility in Norton, MA. Performed typical installation, operational, and performance verification activities for direct and non-direct impact systems including an oligonucleotide synthesizer, tangential flow filtration skids, an HPLC system, a lyophilizer, CIP and distribution systems, portable sanitary vessels, solvent storage and distribution systems, and waste systems. Collaborated with internal Engineering, Automation, Facilities, QC, and Metrology departments along with external contractor teams to achieve project milestones on schedule.

Baltimore, Md, Us

My research in the Ostermeier lab focused on creating modular protein switches to control gene expression via directed evolution. I worked with TAL effectors and nuclease-deactivated cas9, and created protein switch libraries by inserting circularly permuted binding domains.

Master Of Science In Engineering - Mse, Chemical And Biomolecular Engineering

Bachelor Of Science - Bs, Chemical And Biomolecular Engineering