Tracy Gelsinger Email & Phone Number

Waltham, MA, US

Basel, CH

Basel, CH

Basel, CH

• The Codiak clinical manufacturing facility and staff in Lexington, MA was acquired by Lonza in November 2021.
• Serve on the leadership team at the Lonza Lexington site as head of MSAT with a goal to build out the MSAT function at the site to deliver on technology transfer of all exosome processes entering the site.
• Work cross-functionally with internal manufacturing, quality, program management, and QC to ensure harmonization of New Product Introduction (NPI) or Tech Transfer with global Lonza CGT policies.
• Represent MSAT at all client-facing interactions through the following:- Leading project team through the NPI/Tech Transfer process and ensure all documentation and requirements are in place. - Working alongside.
• Lead process and facility fit gap assessments for all incoming processes.
• Author process-related documents including tech transfer protocols/reports, SOPs, WIs, batch records, change controls, deviations/investigations, and CAPAs.

• Assisted in plant startup of IQ/OQ activities for all equipment used in the clinical manufacturing facility’s drug product suite including the filler, sealer, and positive pressure isolator.
• Authored GMP documents including SOPs, WIs, batch records, and reports, and worked within quality systems to drive change controls and deviations to completion.
• Acted as primary point of contact for the receiving unit in technology transfer of downstream and drug product operations, assisting in design, purchase, and implementation of equipment and single use assemblies.
• Supervised a manufacturing associate, mentoring them in their professional development and training them in downstream purification operations on the AKTA.

Somerville, Massachusetts, US

• Supported investigations and continuous improvement initiatives for adherent and suspension derived lentiviral vector (LVV) manufacturing, including the independent planning, execution, and analysis of experiments at.
• Authored and reviewed technical documentation related to internal and external manufacturing activities including protocols, technical reports, manufacturing batch records, SOPs, change controls, deviations, regulatory.
• Proactively identified and proposed mitigations to risks as part of continuous improvement in alignment with regulatory and commercial manufacturing requirements.
• Served as MSAT lead in key initiatives for bringing a product to commercialization, including reviewing master batch records in preparation for PPQ, qualifying a working cell bank for commercial use, and leading.

Watertown, MA, US

• Focused on downstream purification development efforts to wash and concentrate polymeric nanoparticles using centrifugation, TFF, and filtration.
• Applied self-taught SQL to assist with querying the multitude of data from each batch recorded on the PC to gather the relevant information needed to improve future batches.
• Assisted the clinical operations team with compiling materials and running mock blinded clinical studies for Selecta’s Phase 3 clinical trial.
• Kept detailed batch records and recorded observations during factory acceptance testing and site acceptance testing of new manufacturing equipment.
• Drafted experimental plans, executed and documented experiments, analyzed data, and wrote technical reports.
• Generated SOPs with new equipment such as the custom programmable logic controller used during manufacturing polymeric nanoparticles and the AKTA purifier for purifying AAV.

Watertown, MA, US

• Designed and executed experiments to produce polymeric nanoparticles by varying polymers, excipients, evaporation rates, or ratios in a scalable, reproducible and reliable process, focusing efforts on creating stable.
• Focused research efforts on creating novel suspensions of tolerogenic nanoparticles for subcutaneous injection.
• Tested various formulations for lyophilization of Selecta’s polymeric nanoparticle for Phase 3 commercialization efforts, and ran long term stability experiments to determine robustness of each formulation.
• Trained and managed one or more co-op’s day-to-day activities to ensure productivity within the formulation group with proper and safe lab techniques.

• Prepared a multistep organic synthetic radiotracer precursor for detecting β-amyloid plaque in Alzheimer’s patients in conjunction with the radiochemistry group at Massachusetts General Hospital.
• Conducted literature searches on SciFinder to find reaction protocols and worked independently in the lab.
• Purified, isolated, and characterized compounds at each step by TLC, IR, NMR, and LC-MS.
• Researched background information on existing radiotracers for Alzheimer’s disease, compared them to current research being done at the Hanson lab, and presented poster at the Northeastern RISE conference.

• Worked independently to synthesize multi-step large and small-scale macrocyclic compounds by solid phase synthetic techniques.
• Purified organic compounds using HPLC and standard gel chromatography on the Biotage, and identified compounds by LC-MS, and NMR methods.
• Used data analyzed by IC50, Biacore, RLM, HLM, and RASF to work towards a drug candidate to block the IL-17 receptor for an oral treatment for psoriasis.
• Presented relevant data at weekly group meetings, and recorded and maintained detailed procedures and observations into E-notebook.
• Helped to maintain laboratory equipment such as the HPLC, Biotage, Prelude, and lyophilizer.

Waltham, Massachusetts, US

• Developed a new SOP for determining drug release in a variety of different media and extraction techniques in polymeric drug-loaded medical devices.
• Ran routine HPLC, UV, and HS-GC assays on medical devices to determine the concentration of drug loading and residual solvent levels in the devices.
• Maintained the analytical lab by ensuring HPLC equipment was running properly and ordering lab supplies as needed.