Sr Manager, Bioanalytical Development
Proclinical Group, Bedford, NY, United States
Sr Manager - Contract - Bedford, MA
Advance oligonucleotide therapeutics through world‑class bioanalytical development and execution.
Proclinical is seeking a Senior Manager of Bioanalytical Development to support clinical and nonclinical studies in the immuno-oncology and pharmaceutical space. This position requires expertise in oligonucleotide therapeutics and complex biological matrices.
Primary Responsibilities:
The successful candidate will lead the development, validation, and execution of bioanalytical assays for pharmacokinetics (PK) and anti-drug antibodies (ADA), contributing to regulatory filings and cross-functional collaborations.
Skills & Requirements:
Advanced degree (PhD preferred) in Medicinal Chemistry, Analytical Chemistry, Biochemistry, or a related field.
Hands‑on experience in developing oligonucleotide bioanalytical methods and sample extraction techniques for tissue and fluid‑based matrices.
Strong understanding of oligonucleotide chemistry, conjugation, and linker platforms.
Interdisciplinary knowledge of drug discovery and development, including in vitro/in vivo pharmacology, ADME, PK‑PD, translational, and clinical research.
Proficiency in GLP/GCP‑compliant laboratory regulations and ICH guidelines.
Excellent written and verbal communication skills for data reporting, interpretation, presentation, and collaboration across teams.
The Sr Manager's responsibilities will be:
Design, optimize, and validate high‑sensitivity analytical methods such as LC-MS/MS, hybrid‑ELISA, and qPCR for oligonucleotides and metabolites.
Develop and validate ligand‑binding assays (e.g., ELISA, MSD, ECL) for large molecule PK and immunogenicity (ADA, NAb).
Manage the lifecycle of bioanalytical assays from early‑stage development through registration, ensuring alignment with program objectives.
Serve as the primary contact for CROs, overseeing method development, assay transfers, sample analysis, troubleshooting, and auditing to maintain high data standards.
Provide subject matter expertise on study teams, contributing to protocol development, lab manuals, sample management, and bioanalytical data reporting.
Analyze, interpret, and report complex PK and immunogenicity data to support ADME, DMPK, TK, and PK‑PD evaluations across nonclinical and clinical development.
Ensure compliance with global regulatory guidelines, including ICH M10 requirements, and support IND and NDA filings.
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Advance oligonucleotide therapeutics through world‑class bioanalytical development and execution.
Proclinical is seeking a Senior Manager of Bioanalytical Development to support clinical and nonclinical studies in the immuno-oncology and pharmaceutical space. This position requires expertise in oligonucleotide therapeutics and complex biological matrices.
Primary Responsibilities:
The successful candidate will lead the development, validation, and execution of bioanalytical assays for pharmacokinetics (PK) and anti-drug antibodies (ADA), contributing to regulatory filings and cross-functional collaborations.
Skills & Requirements:
Advanced degree (PhD preferred) in Medicinal Chemistry, Analytical Chemistry, Biochemistry, or a related field.
Hands‑on experience in developing oligonucleotide bioanalytical methods and sample extraction techniques for tissue and fluid‑based matrices.
Strong understanding of oligonucleotide chemistry, conjugation, and linker platforms.
Interdisciplinary knowledge of drug discovery and development, including in vitro/in vivo pharmacology, ADME, PK‑PD, translational, and clinical research.
Proficiency in GLP/GCP‑compliant laboratory regulations and ICH guidelines.
Excellent written and verbal communication skills for data reporting, interpretation, presentation, and collaboration across teams.
The Sr Manager's responsibilities will be:
Design, optimize, and validate high‑sensitivity analytical methods such as LC-MS/MS, hybrid‑ELISA, and qPCR for oligonucleotides and metabolites.
Develop and validate ligand‑binding assays (e.g., ELISA, MSD, ECL) for large molecule PK and immunogenicity (ADA, NAb).
Manage the lifecycle of bioanalytical assays from early‑stage development through registration, ensuring alignment with program objectives.
Serve as the primary contact for CROs, overseeing method development, assay transfers, sample analysis, troubleshooting, and auditing to maintain high data standards.
Provide subject matter expertise on study teams, contributing to protocol development, lab manuals, sample management, and bioanalytical data reporting.
Analyze, interpret, and report complex PK and immunogenicity data to support ADME, DMPK, TK, and PK‑PD evaluations across nonclinical and clinical development.
Ensure compliance with global regulatory guidelines, including ICH M10 requirements, and support IND and NDA filings.
#J-18808-Ljbffr