Dan Lippert

Assoc Dir of Project Management @Alkermes

Wilmington, OH, US
EMAILS
d••••••••@alkermes.com
MOBILE NUMBERS
+16•••••••41

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WORK HISTORY

Mar 2023 — Present

Assoc Dir of Project Management @Alkermes

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US

SKILLS

FdaCross-Functional Team LeadershipAnalysisHplcGmpGas ChromatographyPharmaceutical IndustryAnalytical ChemistryR&DSopValidationSix SigmaDrug DevelopmentPharmaceuticsBiotechnologyBiopharmaceuticalsQuality ControlTechnology TransferLimsV&V21 Cfr Part 11Computer System ValidationGlpChange ControlQuality SystemRegulatory RequirementsRegulatory SubmissionsCapaIndGcpGxpRegulatory AffairsClinical DevelopmentCRO

ABOUT DAN LIPPERT

Thirty-two years of experience working in FDA regulated industries.•Demonstrated success in project management, analytical development, product development, and computer system validation.•Manager over Pharmaceutical Development group•Effective communications with internal and external customers, clients and partners•Six Sigma Greenbelt: DMAIC and DFSS•Technical Management/Supervision•Preparation of CMC dossiers for FDA and OUS regulatory agenciesSpecialties: •Project Manager in Pharmaceutical Development•Cross-functional team leadership•Proficient using MS Project•Analytical Method Development, HPLC, GC

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