Associate Director, CMC Analytical Development

SK Life Science•Paramus, NJ

1d•Remote

About The Position

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.

Requirements

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 development through late-stage or NDA readiness.
Experience with HPLC/UPLC, GC/headspace GC, LC-MS, GC-MS, ICP-MS, dissolution, stability-indicating methods, residual solvents, elemental impurities, and extractables and leachables.
Experience developing discriminating dissolution methods and applying BCS principles to compounds with varied solubility and permeability.
Strong knowledge of cGMP, ICH guidance, and compendial requirements for oral dosage forms, including USP-NF, Ph. Eur., and JP.
Direct experience authoring and reviewing analytical CTD Module 3 content for INDs, IMPDs, and NDAs.
Demonstrated oversight of outsourced laboratories and CDMOs, including method transfer, investigations, timelines, budgets, and vendor performance.
Manage multiple priorities and adapt to changing program needs.
Communicate clearly in writing and in cross-functional meetings.
Exercise sound scientific judgment and close attention to detail.
Work effectively under schedule pressure in a virtual environment.

Responsibilities

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
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.
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.
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.
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.