Manager Bioanalytical

Job Title

Design, optimize, and validate robust, high-sensitivity analytical methods (e.g., LC-MS/MS, hybrid-ELISA, and qPCR) for ONTs and metabolites Design, optimize, and validate ligand-binding assays (e.g., ELISA, MSD ECL) for large molecule PK and immunogenicity (ADA, NAb) Oversee life cycle management of bioanalytical assays from early-stage development through registration and across evolving program objectives Analyze, interpret and report complex data (PK and immunogenicity) to support in vitro/in vivo ADME, DMPK, TK, and PK/PD data evaluations across nonclinical and clinical development Ensure all bioanalytical activities are compliant with global regulatory guidelines and ICH M10 requirements, and support IND and NDA filings

DMPK, Immunogenicity, PK assay, Translational biology, assay development, siRNA, conjugated ONTs, tissue, LCMS, ELIs, qPCR, ligand binding assays, Elisa, CRO, in vitro, in vivo, ADME, IND filing

DMPK,Immunogenicity,PK assay,Translational biology,assay development,siRNA,conjugated ONTs,tissue,LCMS,ELIs,qPCR

Ph.D. in Medicinal Chemistry, Analytical Chemistry, Biochemistry, or related field and 3 to 5 years of Analytical and/or Bioanalytical Chemistry laboratory experience including study and CRO management Proven success and hands-on experience in the development of oligonucleotide bioanalytical methods and sample extraction techniques for tissue and fluid-based matrices Demonstrates inter-disciplinary knowledge of drug discovery and development (in vitro/in vivo pharmacology, ADME, PK/PD, translational and clinical research) Proficiency in GLP/GCP-compliant laboratory regulations, ICH guidelines and procedures

Intermediate Level

Job Type & Location This is a Contract position based out of Cambridge, MA.

Pay and Benefits The pay range for this position is $77.00 - $90.00/hr eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:
• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type This is a hybrid position in Cambridge,MA.

Final date to receive applications This position is anticipated to close on Jul 24, 2026.