Senior Manager, Bioanalytical Development (ONTs) 12 months
Contract length: 12 months
Hourly rate: $75 - $100 (flexible upon availability)
Location: Remote to Hybrid - looking for candidates local to the Greater Boston area. Gradual transition to a hybrid schedule toward the second half of the assignment, with 2 days onsite in Bedford, MA.
Open to considering candidates on the East Coast who are willing to re-locate to the Greater Boston area once the hybrid schedule begins (2 days onsite in Bedford, MA during the second half of the assignment).
No sponsorship available (must be authorized to work in the U.S.)
MANDATORY BACKGROUND REQUIREMENT
This role requires hands-on bioanalytical experience with oligonucleotide therapeutics (ONTs), including siRNA, antisense oligonucleotides (ASOs), and/or conjugated oligonucleotides. Candidates without prior oligonucleotide bioanalysis experience will not be considered.
Job Summary
The Department of Quantitative & Clinical Pharmacology (QCP) at Sarepta Therapeutics is seeking applicants for a Senior Manager of Bioanalytical Development in DMPK and Bioanalysis. This role will lead the development, validation, and execution of PK assays specifically for oligonucleotide therapeutics in clinical and nonclinical studies to enable lead optimization, clinical candidate selection, pharmacology evaluations of safety and efficacy, and contributions to regulatory filings.
The incumbent will serve as a functional area representative and partner closely with QCP, Translational Biology, Clinical Operations, and Nonclinical Development and Operations. A successful candidate must have demonstrated success in assay development and validation, clinical and nonclinical study support, regulatory-compliant data analysis and reporting, and CRO management.
Experience in oligonucleotide therapeutics (ONTs), including siRNA, ASOs, and conjugated ONTs, as well as complex biological matrices (CSF, tissues), is required.
Role Responsibilities
- Design, optimize, and validate robust, high-sensitivity analytical methods (e.g., LC-MS/MS, hybrid-ELISA, qPCR) for oligonucleotide therapeutics and their metabolites
- Design, optimize, and validate ligand-binding assays (e.g., ELISA, MSD ECL) for large-molecule pharmacokinetics
- Oversee lifecycle management of bioanalytical assays from early-stage development through registration and across evolving program objectives
- Serve as the primary contact for CROs, providing technical oversight of method development, assay transfer, sample analysis, troubleshooting, and auditing to ensure high data quality standards
- Provide subject-matter expertise on nonclinical and clinical study teams, contributing to study protocol development, laboratory manuals, sample management, and bioanalytical data reporting
- Analyze, interpret, and report complex PK and immunogenicity data to support in vitro and in vivo ADME, DMPK, TK, and PK/PD evaluations across nonclinical and clinical development
- Ensure all bioanalytical activities comply with global regulatory guidelines and ICH M10 requirements, and support IND and NDA filings
Qualifications
- Ph.D. in Medicinal Chemistry, Analytical Chemistry, Biochemistry, or a related field, with 3-5 years of analytical and/or bioanalytical chemistry laboratory experience, including study and CRO management
- Proven, hands-on experience developing and validating bioanalytical methods for oligonucleotide therapeutics, including sample extraction from tissue- and fluid-based matrices
- Strong understanding of oligonucleotide chemistry, conjugation strategies, and linker platforms
- Demonstrated interdisciplinary knowledge of drug discovery and development, including in vitro and in vivo pharmacology, ADME, PK/PD, translational research, and clinical development
- Proficiency with GLP/GCP-compliant laboratory regulations and ICH guidelines and procedures
- Strong written and verbal communication skills for data interpretation, reporting, presentation, and cross-functional collaboration