Cameron I. Email & Phone Number

Boston, Massachusetts, United States

Collaborate extensively with area leads to develop and maintain cohesive project plans, ensuring alignment with objectives.Identify and communicate interdependencies and critical activities on project timelines to optimize planning and execution.Lead the development and oversight of integrated timelines involving cross-functional teams (e.g., Technical Operations, Quality, Regulatory CMC, Supply Chain) to meet Program Team schedules.Monitor significant milestones and decision points, actively engaging with project team members to fulfill commitments and drive project goal attainment.Facilitate clear and efficient communication among team members and stakeholders, providing updates on project status, objectives, risks, and mitigation plans.Manage team communications effectively, organizing meeting agendas, minutes, decision logs, task lists, and risk analyses/mitigation strategies using preferred technologies.Maintain and update project status tools, including project action logs, risk registers, and dashboards, to ensure accurate and current project information.Assist in the creation and deployment of templates to streamline team activities and enhance project management efficiency.

Boston, Massachusetts, United States

• Function as the subject matter expert in analytical science to support HPLC (RP, SEC, IC), spectroscopy (UV/Vis, FTIR, Raman), binding affinity (SPR, Octet, etc.), SDS-PAGE, particle analysis (NTA, DLS, flow imaging, etc.) testing of drug substance and drug product• Collaborate with contract development and manufacturing organization (CDMO) and contract testing lab (CTL) to support analytical activities during process development, preclinical, clinical, and potentially commercial manufacturing• Design studies with internal AD and Quality teams, CDMO, and CTL for VLP and small molecule analytical development, characterization, qualification, validation to support release testing, stability study, and extended characterization• Design/manage execution of experiments (DOE) at external partners to generate optimal and robust analytical assays, and work collaboratively with CDMO on design and execution of experiments• Assess impact and facilitate closure of deviations, ensure appropriate scoping of change controls and CAPAs, and develop risk assessments related to analytical assays• Author and review technical protocols and reports, CMC regulatory sections, assay summaries, study design and protocols, SOPs, etc.• Establish routine analytical data trending activities• Ensure accurate/complete documentation of any scientific experimental plan, data, and report• Build and maintain good working relationships with internal and external stakeholders e.g., Research, Development, Quality, suppliers, contract manufacturing organizations, contract testing labs etc.• Independently analyze data, present results, and conclusions to the team• Establish and maintain familiarity with contemporary industrial standards, practices, technologies, literature, and ways of performing lab studies

Springfield/Worcester Areas

Sudbury, Massachusetts, United States

• Operation/routine maintenance of multiple instruments including HPLC, LCMS, and UV-Vis• Develop analytical methods of oral enzyme therapies, review revisions to procedures• Collaborate for troubleshooting sessions for processes/products manufactured in-house/at CMOs • Collect and review experimental results, interpret data, present and document study results/data summaries, generate reports• Manage chemical inventory, order chemicals and supplies • Maintenance of laboratory notebook/records in accordance with laboratory requirements • Direct experience with the following techniques: Bioassays, ELISA, HPLC, SDS-PAGE, endotoxin testing, capillary electrophoresis, immunoblots, dissolution, cIEF

Shrewsbury, Massachusetts

• Operation and routine maintenance of multiple instruments including HPLC, LCMS, and UV-Vis with a high degree of accuracy, diligence, efficiency, and reliability.• Develop analytical methods of biologics; review and perform revisions to procedures• Collaborate for troubleshooting sessions for processes and products with clients, cultivate robust relationships, and lead complex research and development stage projects with external clients.• Collect and review experimental results, interpret data, present and document study results/data summaries, generate study reports for complex data• Manage chemical inventory, order chemicals and supplies, update and maintain chemicals, samples, and reagents for the department• Firsthand experience with the following techniques: Bioassays, ELISA, HPLC, SDS-PAGE, endotoxin, capillary electrophoresis, chemical derivatization, and N-Terminal Sequencing • Efficiently organize/plan daily activities and provide technical guidance and training technicians. • Work to a high degree of compliance and diligent documentation, suitable for GMP projects.• Work with Quality Assurance to respond to audits and complete reports.• Follow all SOPs, Client Test Methods, and cGMP guidelines as they relate to specific tasks.

Cambridge, Ma

• Oversee the planning/execution of project activities to ensure alignment with the expectations and timelines.• Provides critical support and maintenance for the optical instrumentation held in the centralized facility, training for colleagues, and facilitates new optical microscopy method development. • Develop analytical methods of tissue, cell, and organism visualization.• Collaborate with the team for troubleshooting sessions for processes manufactured in-house and with vendors/CMOs around new, emerging microscopy imaging technologies, instrumentation, and method development.• Collect and review experimental results, interpret data, present/document study results, generate study reports• Manage chemical inventory, including providing logistical support for sample management, ordering chemicals/supplies and conducting bench work activities.• Efficiently review crucial material such as program progress, timeline updates, and risk/opportunity evaluations to management/colleagues. • Serve as an interface to Global Operations and Research BT/IT for equipment/facilities support.

Cambridge, Massachusetts

• Oversaw activities related to donor sample inventory receipt/management under GMP systems.• Inventory management movement and tracking in accordance with GMP guidelines/policies, management of data analysis and project management tools.• Executed analytical method validations and transfers including drafting technical protocols, reports, and troubleshooting. Collaboration with R&D/Analytical Development on aliquots of material for assays and for running bio-analytical assays. BSL II lab environment. • Lead statistical analysis and worked cross functionally/interdepartmentally. • Maintain accurate inventory tracking system, draft/review SOPs for process improvement, present technical information, interact with pertinent entities in a professional capacity, coordinate logistics, supply management and ordering, performed investigations regarding OOS results; CAPA trained. Addressed/managed deviations related to analytical procedures. • Sample receiving and processing, plating, and reading/interpreting • Created/maintained a donor deferral database for donors that do not meet program qualifications. • Maintenance of Employee Donor Initiative, manufacturing/sending out kits, donor reach-out.• Collaboration with off-site venues/research centers for reception/maintenance of donor material. • Active attendance in medical meetings, budget meetings, and other program meetings. • Followed SOPs per GxP guidelines.

Springfield, Massachusetts Area

Admissions, Gift Shop, Miscellaneous tasks.

West Springfield, Massachusetts

Sample receiving and processing, plating and reading/interpreting (SPC, Yeast/Mold, Coli)• DMC/DMSCC, Mojonnier/Kohman fat extraction, Membrane filtration, WPN, TA/Solubility of powder,• Antibiotic testing, data entry, data analysis, sample retention and procurement, Bradford, BSA, ELISA, well-plating, film-plating, aseptic techniques, buchi• DSI computer program, SOP review per GxP guidelines (cGMP, cGLP, cGCP, cGDocP, cGSP)• laboratory/plant swabbing and analysis for Salmonella, Listeria, Cronobacter, and Bacillus• Tissue handling and histology techniques.Aseptic techniques

Springfield, Massachusetts Area

Biochemical/Biophysical Assays, SDS-PAGE, buffer preparation, electron microscopy, Bradford, BSA, ELISA, RT-PCR, SOP review per GxP guidelines (cGMP, cGLP, cGCP, cGDocP, cGSP)• Tissue handling and histology techniques, immunohistochemistry, NanoDrop, spectrophotometer, micro- tubule synthesis,• Microtubule kinetics, maintenance, BSL III lab environment (gowns, double gloves, anaerobic chambers full clothing covering), work on Microtubule Dynamics, Mechanics, Motor Proteins, Severing Enzymes

Co-taught labs, lab prep, assistance in relevant material• exam proctoring communicated difficult topics and encouraged creative applications • C.elegans/ rat & cat dissections (preserved animal handling), genetics, bioinformatics

Bachelor Of Science - Bs, Biochemistry, B.S Accredited By Asbmb, American Society For Biochemistry And Molecular Biology

Activities and Societies: Stonewall Center (LGBTQ) CMASS (Center for Multicultural Advancement and Student Success) LSAMP (Louis Stokes.

Bachelor Of Science - Bs, Molecular Biology, B.S Accredited By Asbmb, American Society For Biochemistry And Molecular Biology

Major, Spanish And Iberian Studies

Major, Spanish Language Teacher Education

High School, Focused On Spanish And Life/Natural Sciences, 4.0 Gpa

Activities and Societies: Local Environmental Activist Force (L.E.A.F) Gay-Straight Alliance (GSA) National Art Honors Society (NAHS).