Dennis B. Email & Phone Number
@novartis.com
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Who is Dennis B.? Overview
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Dennis B. is listed as Director of Analytical Development, CMC at ArriVent Biopharma, based in United States. AeroLeads shows a work email signal at novartis.com and a matched LinkedIn profile for Dennis B..
Dennis B. previously worked as Associate Director, Analytical Development at Arrivent Biopharma and Associate Director / Analytical Project Leader at Novartis. Dennis B. holds Master'S Degree, Chemistry from The City University Of New York (City College).
Email format at ArriVent Biopharma
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AeroLeads found 1 current-domain work email signal for Dennis B.. Compare company email patterns before reaching out.
About Dennis B.
Self-motivated, quality-driven and detailed-oriented chemist with extensive experience in the pharmaceutical industry. Analytical project leader with extensive hands-on experience in analytical research and development for drug substances and drug products, in a cGMP environment. Team player, proven leadership skills, strong organizational and communication skills. Effective at managing multiple priorities, technical supervision, CRO/CMO supervision, RA-CMC and regulatory submission, analytical method development/validation/transfer, setting specification for APIs and finished drug products. Strong knowledge in cGMPs, GLPs, ICH and FDA guidelines, Health & Safety requirements, QbD principles, Trackwise, GLIMS, Novstyle, and Chromeleon.
Listed skills include Assistant Director.
Dennis B.'s current company
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Dennis B. work experience
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Associate Director, Analytical Development
Associate Director / Analytical Project Leader
• Managed the analytical activities for a successful EU submission of the Entresto pediatric formulation. Additional submissions pending for the US, Great Britain, China and Japan. • Interfaced with external partners to lead and monitor outsourcing activities and ensure on time deliverables according to Novartis standards.• Planned and coordinated the transfer of analytical activities to CROs, commercial launch sites and different development sites.• Managed budget and FTE forecast for the assigned projects and tracked these activities on a monthly basis.• Managed all analytical activities for projects in my portfolio. These activities included method development for new APIs, intermediates and drug products, methods validation, clinical batch release, data review and registration stability setup and trending.• Conducted systematic laboratory investigations and root cause analysis for non-conformances and deviations (OOSs, OOEs) and completed tasks for remediation of CAPAs.• Authored and reviewed analytical methods, method transfer protocols & reports, stability protocols & reports, validation protocols and reports and qualification of impurities reports.• Co-authored and reviewed CMC sections for IND, IMPD and NDA submission dossier/amendments and served as a key member in health authority response team and provided timely responses to Health Authority questions.• Trained and supervised junior associates in analytical testing.
Fellow / Analytical Project Leader
• Interfaced with external partners to lead and monitor outsourcing activities and ensure on time deliverables according to Novartis standards.• Planned and coordinated the transfer of analytical activities to CROs, commercial launch sites and different development sites.• Managed budget and FTE forecast for the assigned projects and tracked these activities on a monthly basis.• Managed all analytical activities for projects in my portfolio. These activities included method development for new APIs, intermediates and drug products, methods validation, clinical batch release, data review and registration stability setup and trending.• Conducted systematic laboratory investigations and root cause analysis for non-conformances and deviations (OOSs, OOEs) and completed tasks for remediation of CAPAs.• Authored and reviewed analytical methods, method transfer protocols & reports, stability protocols & reports, validation protocols and reports and qualification of impurities reports.• Co-authored and reviewed CMC sections for IND, IMPD and NDA submission dossier/amendments and served as a key member in health authority response team and provided timely responses to Health Authority questions.
Principal Scientist
• Coordinated all analytical activities for projects in my portfolio. These activities included method development for new APIs, intermediates and drug products, methods validation, clinical batch release, data review and registration stability setup and trending.• Conducted systematic laboratory investigations and root cause analysis for non-conformances and deviations (OOSs, OOEs) and completed tasks for remediation of CAPAs.• Authored and reviewed analytical methods, method transfer protocols & reports, stability protocols & reports, validation protocols and reports and qualification of impurities reports.• Co-authored and reviewed CMC sections for IND, IMPD and NDA submission dossier/amendments and served as a key member in health authority response team and provided timely responses to Health Authority questions.• Trained and supervised junior associates in analytical testing.
Senior Scientist
Analytical development of drug substance and drug product from early to late phase.Setting specificationsWriting Development Stability Reports (DSR)Develop methods, write validation protocols and reports Performed routine and specialized testing as a bench chemist using HPLC, GC, Dissolution apparatus, Titrators, Spectrophotometers, etc.
Scientist
Dennis B. education
Master'S Degree, Chemistry
Bachelor Of Science - Bs(Hons.), Chemistry
Frequently asked questions about Dennis B.
Quick answers generated from the profile data available on this page.
What company does Dennis B. work for?
Dennis B. works for ArriVent Biopharma.
What is Dennis B.'s role at ArriVent Biopharma?
Dennis B. is listed as Director of Analytical Development, CMC at ArriVent Biopharma.
What is Dennis B.'s email address?
AeroLeads has found 1 work email signal at @novartis.com for Dennis B. at ArriVent Biopharma.
Where is Dennis B. based?
Dennis B. is based in United States while working with ArriVent Biopharma.
What companies has Dennis B. worked for?
Dennis B. has worked for Arrivent Biopharma and Novartis.
How can I contact Dennis B.?
You can use AeroLeads to view verified contact signals for Dennis B. at ArriVent Biopharma, including work email, phone, and LinkedIn data when available.
What schools did Dennis B. attend?
Dennis B. holds Master'S Degree, Chemistry from The City University Of New York (City College).
What skills is Dennis B. known for?
Dennis B. is listed with skills including Assistant Director.
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