Associate Director, CMC Analytical Development

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. Support clinically relevant specifications, dissolution-profile comparisons, formulation and site bridging, in vitro-in vivo relationships, and BCS-based biowaiver strategies.

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:

1. 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

2. 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.

3. 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.

4. 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.

5. 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 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.
• Periodic travel to CDMOs, contract laboratories, manufacturing sites, and company meetings may be required.

Compensation & Benefits:

The anticipated salary range for this position is $150,000 to $190,000. Actual compensation may vary based on factors including experience, qualifications, skills, and business needs.

 

In addition to base salary, SK Life Science offers a competitive benefits package, including a 401(k) plan with company match and medical, dental, and vision coverage. Benefits are subject to eligibility requirements and may be modified at the Company's discretion.