Kailera Therapeutics, Inc.
Therapies
AssociateDirector,BioanalyticalSciences
“Associate Director, Bioanalytical Sciences at Kailera Therapeutics, Inc.. Skills: Bioanalytical strategy, Regulated bioanalysis, CRO management. Design bioanalytical strategy. Execute bioanalytical strategy”
Industry & Context.
What They're Looking For.
Must Have
10+ years of relevant industry experience in bioanalytical sciences with a Bachelor’s degree, 5+ years with an advanced degree, Expertise in regulated bioanalysis, Clinical-stage drug development, In-depth knowledge of GLP/GCP requirements, Industry best practices in bioanalytical laboratories, Proven experience in the regulatory requirements for method development and validation, Track record of managing CRO-outsourced bioanalysis and vendor relationships, Excellent project management skills, Ability to manage multiple priorities effectively, Experience with regulatory interactions, Experience contributing to regulatory filings for biologics and small molecules, Bachelor's degree in a relevant scientific discipline
Nice to Have
PhD preferred, Experience with GLP-1 receptor agonists, Related therapeutic areas, Understanding of bioanalytical considerations for incretin-based therapies
What You'll Do.
Design bioanalytical strategy
Execute bioanalytical strategy
Oversee GLP-compliant bioanalysis
Manage outsourced bioanalysis
Advance drug candidates
Develop bioanalytical assays
Validate bioanalytical assays
Implement bioanalytical assays
Author regulatory submissions
Review regulatory submissions
How You'll Work.
Team & Collaboration
Partner with cross-functional teams; Represent bioanalytical function in project teams
Process & Methodology
Project management skills, Manage multiple priorities
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