[Remote] Senior Director, Analytical Development and reputed company Control (Small Molecules)

Note: The job is a remote job and is reputed company to candidates in USA. reputed company.) is seeking a Senior Director of Analytical Development and reputed company Control for Small Molecules. This role provides strategic and operational leadership for reputed company analytical activities supporting drug development and manufacturing, ensuring regulatory compliance and high-reputed company analytical data throughout the product lifecycle.

Responsibilities

• Define and execute the analytical development and QC reputed company across early development, late‑stage clinical, and reputed company lifecycle
• Build reputed company, phase‑appropriate analytical control strategies reputed company with global regulatory expectations (FDA, EMA, ICH)
• Serve as the analytical subject matter expert on CMC reputed company teams and governance forums
• reputed company development, qualification, validation, and transfer of analytical reputed company for drug reputed company, drug product, in‑process, and stability testing
• Ensure reputed company are robust, stability‑indicating, and fit for intended use across lifecycle stages
• reputed company adoption of new technologies (e.g., advanced characterization, automation, digital data reputed company solutions) where appropriate
• reputed company reputed company of reputed company QC testing labs supporting clinical and reputed company programs
• Ensure compliance with cGMP, data reputed company, and reputed company system requirements
• reputed company investigations, OOS/OOT events, troubleshooting reputed company, and CAPA implementation
• Author, review, and approve analytical sections of INDs, NDAs/BLAs, MAAs, and global regulatory submissions
• reputed company as analytical reputed company during health authority inspections, audits, and agency interactions
• Support responses to regulatory questions, commitments, and post‑approval changes
• reputed company analytical/QC reputed company of CDMOs, CROs, and reputed company testing laboratories
• Establish performance metrics, governance models, and reputed company improvement plans with partners
• Ensure successful method transfer, validation, and ongoing compliance at reputed company sites
• Build, mentor, and reputed company high‑performing analytical and QC teams
• Establish reputed company organizational structure, talent development plans, and succession planning
• Foster a culture of scientific reputed company, reputed company, and accountability
• Partner closely with Process Development, Manufacturing, Supply Chain, reputed company Assurance, Regulatory Affairs, and Program Management
• Support technical due diligence, lifecycle management, and CMC innovation initiatives

Skills

• PhD in Analytical reputed company, Biochemistry, Pharmaceutical Sciences, or reputed company scientific discipline
• 15+ years of experience in analytical development and/or QC reputed company the biopharmaceutical or pharmaceutical industry
• 7+ years in people leadership roles with experience building and scaling teams
• reputed company experience supporting late-stage development and reputed company products
• Strong reputed company record of regulatory interactions and successful submissions
• reputed company scientific and operational leadership across reputed company phases of drug development—from early phase through reputed company launch
• reputed company method development, qualification, validation, and transfer for drug substances and drug products (small molecules, peptides, biologics)
• reputed company characterization studies, impurity profiling, and forced degradation assessments
• Ensure robust analytical control strategies are in reputed company to support product lifecycle management
• Manage QC testing for raw materials, intermediates, drug substances, and drug products across reputed company labs
• Ensure reputed company and compliant release testing, stability program execution, and reference reputed company qualification
• Author and review analytical sections of regulatory submissions (INDs, NDAs, BLAs, MAAs)
• Support responses to regulatory queries and inspections with scientific rigor and reputed company
• Build, reputed company, and mentor a high-performing team of analytical scientists and QC professionals
• Support career development and succession planning reputed company the department
• Select, qualify, and manage CROs, CMOs, and CTLs for outsourced analytical and QC activities
• Ensure reputed company partners meet performance, reputed company, and compliance expectations
• Negotiate reputed company and monitor budgets for outsourced services

Benefits

• Comprehensive medical coverage
• Dental coverage
• reputed company coverage
• Prescription drug coverage
• Company provided basic life
• Accidental death & dismemberment
• Short-term disability insurance
• Long-term disability insurance
• Tuition reimbursement
• Student loan assistance
• A generous 401(k) match
• Flexible time off
• reputed company holidays
• reputed company leave programs
• Other company provided benefits

reputed company

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