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@novavax.com
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Cecilia Tran is listed as Senior Program Manager at Novavax specializing in Drug Development and Program Management at Novavax, based in San Diego, California, United States. AeroLeads shows a work email signal at novavax.com, phone signal with area code 858, 732, and a matched LinkedIn profile for Cecilia Tran.
Cecilia Tran previously worked as Senior Program Manager, Global Program Management at Novavax and Program Manager, Global Program Management at Novavax. Cecilia Tran holds Master Of Science - Ms, Drug Development And Product Management from Uc San Diego - Skaggs School Of Pharmacy And Pharmaceutical Sciences.
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I am an analytical and methodical program manager with progressive experience in managing parenteral drug products and in-vitro diagnostic (IVD) products. Well-prepared to contribute program/portfolio management, risk management, process optimization, report generations, and relationships building skills for the growth of the organization.Softwares I’m excelled at: MS Project, PowerBI, SmartSheet, Oracle NetSuite, MasterControl, VeevaVault, BlueCielo Meridian, Visio, Atlassian Jira, Citrix ShareFile, MS SharePoint, and MS Office Suite.
Listed skills include Microsoft Excel, Microsoft Word, Research, Teamwork, and 42 others.
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Gaithersburg, Maryland, Us
Manage CMC development for co-formulated COVID-Influenza combination (CIC) investigational vaccine to support Phase 3 and Lot-to-Lot clinical trials and ensure Clinical Trial Material's delivery, release, and regulatory submission are in time for FSI.Plan CMC activities for co-formulated COVID-Influenza combination (CIC) investigational vaccine to support PPQ campaigns for BLA submission.
Gaithersburg, Maryland, Us
♦ Global Program Manager Lead for Drug Product Manufacturing Programs (clinical manufacturing, PPQ, label & pack, CMO site readiness, commercial launch, new DP presentation, etc.) for coronavirus and influenza vaccines.♦ Manage global CMC regulatory submissions (IND, BLA, EUA, CMA, MAA, etc.), post-approval amendments and commitments.♦ Manage project, program, and portfolio-level risks for coronavirus and influenza vaccines.
Carlsbad, Ca, Us
Provided overall program management at a strategic and tactical level to 17 plus IVD, life science, medical device, and drug product companies. Supported new business development to expand the company's portfolio. Provided management on internal CapEx & OpEx projects, such as commissioning a new manufacturing facility for Positive Control templates and new automated equipment. Consulted and generated project document templates for the PMO.Selected Contributions: ♦ Executed tech transfer of seven COVID-19 products (IVD and med devices) under EUA guidelines, in which 4 products obtained EUA-Approved status.♦ Executed tech transfer and provided CMC program management for three drug products, in which one is a Phase 3 COVID-19 vaccine.
San Diego, California, Us
Consulted and managed an Electronic Document Management System (EDMS) upgrade project (paper-based to electronic) by using data management methodologies, PMBOK, and Lean Six Sigma tools.Consulted and prepared new Standard Operating Procedures (SOPs) for the commissioning of a new Multi-Viral Vector Plant to support the commercialization of a gene therapy product.Detailed Responsibilities:♦ Re-mediated all engineering & validation documents’ discrepancies and constructed a temporary document repository on SharePoint. ♦ Performed SWOT analyses on two EDMS enterprise software (VeevaVault and Meridian/BlueCielo).♦ Consulted the client on making strategic decision on the future of their internal engineering & validation documentation libraries for R&D (non-GMP) and Clinical/Commercialization (GMP). ♦ Compiled meta-data for all effective documents using Excel Macro, and mass migrated all existing documents onto the new EDMS.♦ Drafted SOPs and trained other personnel in GDP to ensure consistency and quality of engineering documents per GDP and GEP (Good Engineering Practice) standards.♦ Assisted the team in all documentation and projects coordination needs to ensure successful engineering & validation project completion.
San Diego, California, Us
Liaised and functioned closely with SMEs from various departments, clients, and vendors to produce detailed reports on deviation, out-of-specification, corrective action plans, and risk assessment. Selected Contributions:♦ Examined corrective action and preventive action plans, carried out audit of assigned functional areas, recommended adjustments where required, and approved final audit report.♦ Successfully closed more than 20 deviations during the first quarter of this year.♦ Administered expectations from internal departments, external client, and regulatory agencies using various project management tools (PMBOK, lean, agile, etc.) while working as drug product investigator.
San Diego, California, Us
Determined major system level deficiencies in quality metrics trend data, client audit reports, clinical and commercial market place performance indicators, industry guidance documents, and current inspection trends. Supported on improving new manufacturing facility for Antibody-Drug Conjugates (ADC) and high-potency compounds. Selected Contributions:♦ Internally audited six functional groups, resulting in numerous deviations, CAPA, change control projects to continuously improve compliance and prepare the company audit-ready for client and regulatory agencies. ♦ Participated and supported numerous PAI (Pre-Approval Investigation) audits and other periodical regulatory audits from CDER & CBER (FDA), EMEA, PMDA (Japanese regulatory agency), HPRA (Irish regulatory agency), etc. ♦ Audited manufacturing readiness for a new ADC (antibody drug conjugates) facility in collaboration with Capex project team to ensure facility comply with Code of Federal Regulations, OSHA, and Lean (using Lean Six Sigma tools).
San Diego, California, Us
Demonstrated technical expertise while working on manufacturing equipment such as ROTA FLR 150 vial filler and OPTIMA syringe filler. Diagnosed complex manufacturing processes under cGMP guidelines and supervision of manufacturing group lead. Developed scalable processes with better product yield and adopted Lean Six Sigma initiatives that aided in reducing manufacturing systems costs. Rendered expertise as a SME on Laboratory Information Management System (LIMS) and provided training to other operators to become LIMS SMEs.Selected Contributions:♦ Researched, adopted, and implemented up-to-date methods and innovative technologies to improve operations.♦ Drafted well-defined SOPs and reviewed Master Production Records (MPRs) under cGMP guidelines, ensuring seamless execution of manufacturing work.♦ Successfully closed over 50 deviation investigations, 30+ CAPAs, and more than 10 change management projects. ♦ Created a technical writer role to support the non-conformance incidences, leading to restructuring of organization as well as received a new title as “Drug Product Investigator”.
San Diego, California, Us
Adhered to defined guidelines of SOPs and cGMP regulations while performing multiple routine manufacturing tasks. Ensured smooth running of functions by executing production and manufacturing procedures. Received training and gained experienced in various manufacturing areas such as preparation, formulation, filtration, and filling of material. Revised and updated current SOP guidelines to reflect corrective/preventive action and improvement assessments incorporated to avoid operators from deviating the SOP again.Selected Contributions:♦ Collaborated with project team and clients (pharmaceutical companies) to execute study protocols such as machinability studies, stability studies, thaw/hold time studies, and CCIT (container closure integrity test) for IND, NDA, BLA, and ANDA filings with the FDA.♦ Completed more than five change control/continuous improvement projects and successfully managed over 10 CAPAs while working as a fill operator.
La Jolla, Ca, Us
♦ Created lesson plans consisted of material summary and practice problems in order to prepare students for midterm and final exams.♦ Facilitated discussion workshops where 20-30 students worked in groups and collaborated with each other to solve practice problems.♦ Conducted office hours for additional one-on-one tutoring sessions.
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Cecilia Tran works for Novavax.
Cecilia Tran is listed as Senior Program Manager at Novavax specializing in Drug Development and Program Management at Novavax.
AeroLeads has found 1 work email signal at @novavax.com for Cecilia Tran at Novavax.
AeroLeads has found 2 phone signal(s) with area code 858, 732 for Cecilia Tran at Novavax.
Cecilia Tran is based in San Diego, California, United States while working with Novavax.
Cecilia Tran has worked for Novavax, Argonaut Manufacturing Services Inc., Sequoia Consulting Group,Llc, Ajinomoto Bio-Pharma Services, and University Of California San Diego.
You can use AeroLeads to view verified contact signals for Cecilia Tran at Novavax, including work email, phone, and LinkedIn data when available.
Cecilia Tran holds Master Of Science - Ms, Drug Development And Product Management from Uc San Diego - Skaggs School Of Pharmacy And Pharmaceutical Sciences.
Cecilia Tran is listed with skills including Microsoft Excel, Microsoft Word, Research, Teamwork, Customer Service, Photoshop, Powerpoint, and Microsoft Office.
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