Ben Roberts Email and Phone Number
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Senior manager with 14 years of experience leading teams in Drug Product R&D lab operations, DP/fill-finish (FF) tech transfers and process development initiatives with a strong focus in formulation development and fill finish operations systems for cell and gene therapies, biologics, and small molecule products. Experience includes tech transfers, product development, experimental design, process development, CMO management, and process validation. Experience in supporting BLA and IND approval to both US and ROW markets.
Novartis
View- Website:
- novartis.com
- Employees:
- 79781
- Company phone:
- +41 61 324 11 11
- Company email:
- eric.althoff@novartis.com
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Associate Director, Cell And Gene Therapy Drug Product Process DevelopmentNovartisRaleigh, Nc, Us
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Senior ManagerNovartis Jan 2023 - PresentBasel, Baselstadt, ChResponsible for managing technical operations and personnel in Technical Research & Development Drug Product laboratoryLeads team of associate experts responsible for execution of drug product process development initiatives in R&D drug product development labLead expert for new product & process development activities supporting pre-clinical and clinical phase gene therapies in US and ROW markets for novel cell and gene therapy solutionsResponsible for program process development strategies, process development study design and execution
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Senior Expert, Cell & Gene Therapy Drug Product Process DevelopmentNovartis May 2022 - May 2023Basel, Baselstadt, ChResponsible for managing technical operations and personnel in Technical Research & Development Drug Product laboratoryLeads team of associate experts responsible for execution of drug product process development initiatives in R&D drug product development labLead expert for new product & process development activities supporting pre-clinical and clinical phase gene therapiesResponsible for program process development strategies, process development study design and execution
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Sr. Scientist, Drug Product Technical DevelopmentNovartis Mar 2019 - May 2022Basel, Baselstadt, ChDrug product process owner responsible for process development activities supporting platform development, internal and external manufacturing fill-finish activities. Experience supports BLA and IND filings for US, EU, and global markets.
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Ms&T Engineer Iii - Drug Product Tech TransferSeqirus Oct 2017 - Feb 2019Melbourne, Victoria, AuTechnical lead for drug product tech transfers of fill/finish manufacturing operations from internal sites to CMOs (US, EU). Responsibilities include post-approval development activities. Direct support in BLA and sBLA filings for US and ROW markets. -
Process EngineerJedson Engineering Sep 2016 - Oct 2017Cincinnati, Oh, UsProcess design, process engineering for biopharmaceutical applications -
Senior Process EngineerBarry-Wehmiller Design Group Apr 2014 - Sep 2016St Louis, Missouri, Us -
Process EngineerBarry-Wehmiller Design Group Apr 2012 - Apr 2014St Louis, Missouri, Us
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Consultant-Bwdg, Process EngineerCatalent Pharma Solutions Oct 2015 - Aug 2016Somerset, Nj, UsValidation team member responsible for generation, composition, and execution of IOQ, EPQ, and PPQ protocols for multiple pMDI filling and packaging lines available for commercial use -
Consultant-Bwdg, Validation EngineerGsk Oct 2014 - Oct 2015Brentford, Middlesex, GbValidation team member responsible for generation and review of validation documentation for 200+ GMP process systems (solid dose process systems, utilities, ancillary, etc.) as a part of secondary Pilot Plant decommissioning. Additionally responsible for completing and reviewing Periodic Validation Reviews (PVR), IOQ protocols, Impact and Risk Assessments, change controls, and additional general validation documentation. -
Consultant-Bwdg, Sr. Process EngineerBurt'S Bees Apr 2012 - Sep 2014Durham, Nc, UsTeam lead responsible for process development and tech transfer of seven (7) OTC drug products, and one (1) Active Pharmaceutical Ingredient to multiple contract manufacturers located across Northeastern US. Responsibilities include schedule management, protocol design, sampling plan development, establishing analytical and fill specifications through process capability data analysis, method transfer and validation, risk assessments, process validation. -
Process Engineering TechnicianHospira May 2010 - Mar 2012Lake Forest, Il, UsProcess engineering mixing team lead responsible for executing laboratory and production scale mixing studies in a GMP environment through the use of PAT in multiple parenteral business units. Responsibilities included protocol development and execution, managing and communicating timelines, data generation and analysis, Design of Experiments (DOE), leading operator training.
Ben Roberts Skills
Ben Roberts Education Details
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North Carolina State UniversityChemical Engineering -
North Carolina State UniversityApplied Mathematics
Frequently Asked Questions about Ben Roberts
What company does Ben Roberts work for?
Ben Roberts works for Novartis
What is Ben Roberts's role at the current company?
Ben Roberts's current role is Associate Director, Cell and Gene Therapy Drug Product Process Development.
What is Ben Roberts's email address?
Ben Roberts's email address is be****@****ent.com
What is Ben Roberts's direct phone number?
Ben Roberts's direct phone number is +191950*****
What schools did Ben Roberts attend?
Ben Roberts attended North Carolina State University, North Carolina State University.
What skills is Ben Roberts known for?
Ben Roberts has skills like Validation, Gmp, Process Engineering, Design Of Experiments, Process Simulation, Data Analysis, V&v, Pharmaceutical Industry, Fda, Quality Assurance, Minitab, Manufacturing.
Who are Ben Roberts's colleagues?
Ben Roberts's colleagues are Girish Rupani, Patricia Fernandes, Chitra Shanbhag, Phd, Peter Wegmüller, Erica Sun, Elsa Boyes, Alzira Piedra Ornelas.
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