Senior Manager, Bioanalytical Development (DMPK & Immunogenicity)

Hybrid in Boston, MA, US • Posted 1 day ago • Updated 1 day ago
Contract W2
12 Months
No Travel Required
Hybrid
Depends on Experience
Fitment

Dice Job Match Score™

🛠️ Calibrating flux capacitors...

Job Details

Skills

  • ADA
  • Analytical Chemistry
  • Assays
  • Biochemistry
  • Chemistry
  • Collaboration
  • ELISA
  • GLP
  • Good Clinical Practice
  • Google Cloud Platform
  • Management
  • Mergers and Acquisitions
  • Pure Data
  • Regulatory Compliance
  • Tk

Summary

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 (siRNA, 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.
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.
  • Dice Id: 91099677
  • Position Id: 9006274
  • Posted 1 day ago
Contact the job poster
VC

Vijay Chepyala

Recruiter @ Talent Groups
Create job alert
Set job alertNever miss an opportunity! Create an alert based on the job you applied for.

Similar Jobs

Boston, Massachusetts

Today

Full-time

Compensation information provided in the description

Boston, Massachusetts

Today

Full-time

Compensation information provided in the description

Boston, Massachusetts

Today

Full-time

Compensation information provided in the description

Boston, Massachusetts

Today

Full-time

Compensation information provided in the description

Search all similar jobs