Alicia Kramer Email and Phone Number
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Alicia Kramer personal email
As the current Process Development Manager at Comprehensive Cell Solutions (CCS), I have been working to establish and lead the Process Development team and be prepared for clients! Previously I was a Process Development Sr. Supervisor at Talaris Therapeutics. At Talaris I led the team in developing the FCR001 process. I collaborated cross-functionally to further the FCR001 CMC Master Plan and work towards a BLA submission. Prior to Talaris, I worked at Juno Therapeutics for 5 years in various roles. As a Manufacturing Associate and Manufacturing Compliance Specialist, I spent time executing the clinical, Liso-cel (Breyanzi) CAR-T process, as well as authoring quality documents such as deviations, change controls, CAPA’s, and batch records. After my time in Manufacturing, I joined the Liso-cel Platform Team in which I managed many Process Development projects and supported the Liso-cel program through a BLA filing and ultimately, a successful approval. During this role I project managed a technical development team and led various project sub-teams. I enjoy being a leader and role model to help further both the program goals and coach direct reports in their careers.In my time outside of work, I enjoy reading as much as I can and enjoy discussing books. I've read about 130 books this year and I would love to hear what books you have loved recently!
Comprehensive Cell Solutions (Ccs)
View- Website:
- comprehensivecellsolutions.com
- Employees:
- 24
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Comprehensive Cell Solutions (Ccs)Houston, Tx, Us
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Manager, Process DevelopmentComprehensive Cell Solutions (Ccs) Oct 2023 - PresentNew York , New York , Us
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Scientist, Process Development, Cell TherapyZiopharm Oncology (Now Alaunos) Aug 2021 - Sep 2021- Effectively designed and executed experiments to support process development for the Library TCR-T IND product.- Supported manufacturing failure investigations by compiling relevant data and executing investigational studies to determine root cause. - Timely and thorough documentation and completion of electronic laboratory notebooks.
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Sr. Specialist, Engineer Ii, Liso-Cel Platform TeamBristol Myers Squibb Mar 2021 - Aug 2021Lawrence Township, Nj, Us- Effectively designed and executed experiments to support process development for BMS' first commercial cell therapy, Breyanzi- Performed statistical data analysis and collaborated with statisticians to draw study conclusions- Presented and authored reports detailing experimental findings and results- Timely and thorough documentation and completion of electronic laboratory notebooks- Relevant projects I led from the Process Development perspective include: - Implementing a filter into the media preparation process - Changing the final drug product container from a manually filled vial to a semi-automatedly filled vial - Improving the method for calculating the vector volume to be added to the cell culture.- Supported regulatory filings, such as BLA's and IND's, by providing experiment data, completing reports, drafting agency question responses, and/or performing data verification on submission content- Led cross-functional and cross-program team to investigate solutions to improve the Manufacturing Success Rate- Project managed the Breyanzi Technical Development Team, including managing agendas and minutes, and facilitating meetings- Updated and managed the Liso-cel team batch records to ensure alignment across the team and manufacturing- Hired and onboarded direct report on the Liso-cel Platform Team -
Specialist, Bioengineer I, Liso-Cel Platform TeamBristol Myers Squibb Apr 2020 - Aug 2021Lawrence Township, Nj, Us- Effectively designed and executed experiments to support late-stage cell therapy process development- Performed statistical data analysis and collaborated with statisticians- Presented and authored reports detailing experimental findings and results- Timely and thorough documentation and completion of electronic laboratory notebooks- Supported regulatory filings, such as BLA's and IND's, by providing experiment data, completing reports, and/or performing data verification on submission content
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Associate Bioengineer I, Post-Pivotal Process DevelopmentBristol Myers Squibb Jul 2019 - Apr 2020Lawrence Township, Nj, Us- Effectively designed and executed experiments to support late-stage cell therapy process development- Performed statistical data analysis and collaborated with statisticians- Presented and authored reports detailing experimental findings and results- Timely and thorough documentation and completion of electronic laboratory notebooks- Supported regulatory filings, such as BLA's and IND's, by providing experiment data, completing reports, and/or performing data verification on submission content
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Manufacturing Compliance SpecialistJuno Therapeutics, Inc. Jul 2018 - Jun 2019Seattle, Wa, Us- Authored and investigated Manufacturing deviations- Implemented Corrective and Preventative Actions- Authored Manufacturing Batch Records and other procedures- Proposed and executed Manufacturing improvements- Represented department on cross-functional project teams, including the Pre-PPQ Team -
Manufacturing Associate IiJuno Therapeutics, Inc. Sep 2017 - Jul 2018Seattle, Wa, Us- Performed patient process unit operations and supported operations according to standard operating procedures and batch records- Trained new hires on manufacturing operations- Utilized aseptic technique according to ISO clean room standards- Upheld Good Manufacturing and Documentation Practices
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Manufacturing Associate IJuno Therapeutics, Inc. Sep 2016 - Sep 2017Seattle, Wa, Us- Performed patient process unit operations and supported operations according to standard operating procedures and batch records- Utilized aseptic technique according to ISO clean room standards- Upheld Good Manufacturing and Documentation Practices
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Certified Pharmacy TechnicianMedicap Pharmacy Feb 2014 - May 2016- Entered prescriptions and insurance information and filled prescriptions- Helped the customers at the cash register and answered questions and telephones to the best of my ability- Delivered prescriptions to those unable to travel to the pharmacy- Completed the money deposits and basic paperwork- Basic cleaning and maintenance of the pharmacy
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Events Co-Director, Executive Board Position For A Student-Run Philanthropic OrganizationIowa State Dance Marathon Feb 2015 - Feb 2016Ames, Iowa, UsBeing the Events Co-Director for Iowa State Dance Marathon was a life-changing experience. - Along with 20 fellow Executive Members and 180 committee members, we raised over $362,000 for the University of Iowa Children's Hospital- Successfully put on two, 12 hour Dance Marathon Events for over 800 Iowa State Students, Dance Marathon Families, Community Members, High School Students, and Faculty Members -
Summer Intern, Technology Transfer DepartmentStreck May 2015 - Aug 2015La Vista, Ne, Us- Worked on projects that contributed to the overall quality system- Projects included laboratory work and completing validations- Presented and completed a report detailing the completion of my projects -
Certified Pharmacy TechnicianCenter Point Family Pharmacy Apr 2009 - Aug 2013- Entered prescriptions and insurance information and filled prescriptions- Helped the customers at the cash register and answered questions and telephones to the best of my ability- Delivered prescriptions to those unable to travel to the pharmacy- Completed the money deposits and basic paperwork- Basic cleaning and maintenance of the pharmacy
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Certified Pharmacy TechnicianHy Vee Aug 2011 - Jul 2013West Des Moines, Ia, Us- Entered prescriptions and insurance information and filled prescriptions- Helped the customers at the cash register and answered questions and telephones to the best of my ability- Basic cleaning and maintenance of the pharmacy
Alicia Kramer Skills
Alicia Kramer Education Details
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Iowa State UniversityChemical Engineering
Frequently Asked Questions about Alicia Kramer
What company does Alicia Kramer work for?
Alicia Kramer works for Comprehensive Cell Solutions (Ccs)
What is Alicia Kramer's role at the current company?
Alicia Kramer's current role is Cell Therapy Scientist and Leader | Helping to Optimize and Advance Cell Therapy Processes.
What is Alicia Kramer's email address?
Alicia Kramer's email address is al****@****stx.com
What schools did Alicia Kramer attend?
Alicia Kramer attended Iowa State University.
What are some of Alicia Kramer's interests?
Alicia Kramer has interest in Children, Medical Discoveries, Healthcare, Dance Marathon, Reading, Science And Technology, Spending Time With Family And Friends, Health.
What skills is Alicia Kramer known for?
Alicia Kramer has skills like Pharmacueticals, Organization, Personal Responsibility, Professional Responsibility, Engineering, Computers, Communication, Multi Tasked, Intelligence, Microsoft Office, Powerpoint, Microsoft Excel.
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