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Senior Manager, Bioanalytical Development (DMPK & Immunogenicity)

Job

Talent Groups

Remote

Full-Time

Posted 2 weeks ago (Updated 1 week ago) • Actively hiring

Expires 7/26/2026

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Job Description

Location:
Remote to Hybrid (Greater Boston Area, MA) We are seeking an experienced Senior Manager, Bioanalytical Development to lead the development, validation, and execution of PK and immunogenicity assays supporting nonclinical and clinical programs. The ideal candidate will have strong expertise in oligonucleotide therapeutics (si
RNA, ASO
), DMPK, ADA/NAb assays, CRO management, and regulatory-compliant bioanalytical method development.
Key Responsibilities:
Develop and validate LC-MS/MS, qPCR, ELISA, and MSD-based bioanalytical assays. Support PK, DMPK, TK, PK/PD, and immunogenicity studies. Manage CROs and oversee assay transfer, troubleshooting, and sample analysis. Collaborate with cross-functional teams on study design, data interpretation, and regulatory submissions. Ensure compliance with GLP/Google Cloud Platform and ICH M10 guidelines.
Requirements:
PhD in Analytical Chemistry, Biochemistry, Medicinal Chemistry, or related field. 3+ years of bioanalytical development experience. Strong experience with oligonucleotide therapeutics and complex biological matrices. Expertise in PK, ADA, NAb assays, and regulatory submissions. Experience managing external CROs.