Associate Director,CMC Analytical Development Job Paramus area,New Jersey USA,Research/Development

Overview

Lead analytical development for small-molecule API and based drug products from IND-enabling studies through NDA readiness in a virtual, outsourced model.
Direct analytical methods, stability, specifications, impurity controls, and performance testing for drug substance and drug product.
Manage CDMOs, CROs, budgets, and submissions against clinical and regulatory timelines.

Responsibilities Analytical Development

Drive overall control strategy and Justification of specification for release and stability
Develop phase-appropriate analytical and control strategies for drug substance, excipients, intermediates, and drug products focused on oral dosage forms.
Oversee method development, transfer, validation, and lifecycle management for assay, impurities, chiral purity, water, and physical characterization.
Lead residual-solvent risk assessment and controls, including headspace GC, and elemental-impurity risk assessments and testing, including ICP-MS, in line with ICH requirements.
Direct ICH stability, forced-degradation, reference-standard, specification, comparability, and shelf-life activities.
Set extractables and leachables strategies for container-closure and product-contact materials; oversee external GC-MS, LC-MS, and ICP-MS studies.
Define analytical testing requirement for container closure involved
Define microbiological and antimicrobial related requirements
Guide cleaning verification related method development
Support analytical methods required in any other formulation and process development
Involve in management of reference standards and API inventory required at CDMO

Dissolution and Biopharmaceutics

Develop discriminating and, when appropriate, biorelevant dissolution methods for oral dosage forms across BCS Classes I-IV.
Assess apparatus, media, pH, surfactant, sink conditions, precipitation risk, particle size, solid form, formulation variables, and manufacturing-process parameters.
Support clinically relevant specifications, dissolution-profile comparisons, formulation and site bridging, in vitro-in vivo relationships, and BCS-based biowaiver strategies.

External Partner and Quality Oversight

Select and govern CDMOs, CROs, and testing laboratories; define scopes, review proposals, manage timelines and budgets, and monitor technical performance.
Review protocols, methods, specifications, reports, certificates of analysis, validation packages, stability data, and batch documentation.
Lead OOS, OOT, deviation, change-control, CAPA, and data-integrity investigations; support vendor audits and inspection readiness.

Regulatory and Compendial Compliance

Apply cGMP, applicable ICH guidance, and dosage-form requirements in USP-NF, Ph. Eur., JP, and other relevant pharmacopoeias to methods, specifications, and control strategies.
Author and review analytical CMC content for INDs, IMPDs, NDAs, amendments, annual reports, briefing documents, and health-authority responses.
Prepare CTD Module 3 analytical sections covering specifications, procedures, validation, batch analyses, impurities, reference standards, dissolution, container-closure systems, and stability.

Cross Functional Leadership

Represent Analytical Development on CMC program teams and communicate risks, recommendations, timelines, and resource needs to internal leaders and external partners.
Collaborate with formulation, process chemistry, manufacturing, quality, regulatory, toxicology, packaging, clinical supply, project management, and finance.

Qualifications

Bachelor's degree or equivalent with a minimum of 12 years of relevant experience, or Pharm.

D., master's degree, or Ph.D. with at least 8 years of relevant experience.
Analytical development experience with small-molecule drug substances and oral drug products from early…

Associate Director, CMC Analytical Development