Director of Analytical Development & QC (Remote/Hub)

kailera; United States; Hybrid; USD 180,000 - 240,000; Full time

Job summary

Kailera is seeking a Director, Analytical Development and Quality Control to lead analytical development, validation, and lifecycle management for sterile parenteral products, driving regulatory readiness and NDA support.

The ideal candidate brings 10+ years in pharma/biotech with HPLC/UPLC and LC-MS expertise, solid cGMP/regulatory background, and proven CRO/CMO management. Waltham, MA hub-based with remote options.

Qualifications

• 10+ years in pharma/biotech with experience in all phases of drug development and NDA/MAA filings.
• Expertise in analytical techniques HPLC/UPLC, LC-MS, SE-HPLC.
• Knowledge of cGMP, quality systems, ICH guidelines, USP/EP/JP/ CHP.
• Experience working with CROs/CMOs and managing external analytical development and QC activities.
• Proven leadership with mentoring staff.
• Strong communication and cross-functional collaboration.
• Energetic team-player in dynamic environment.

Responsibilities

• Lead analytical development, control strategy, and lifecycle management for sterile injectable/parenteral products from development through commercialization, including method development, validation, transfer, QC implementation, and commercial support.
• Define and execute analytical CMC strategies, regulatory submissions, and control frameworks, including NDA Module 3 content, analytical data packages, specifications, characterization, validation, stability, and commercial release requirements.
• Ensure scientifically sound, regulatory-compliant analytical programs by leading technical issue resolution, risk management, resource planning, agency interactions, and compliance with FDA, ICH, and pharmacopeial expectations.
• Provide analytical leadership for product characterization, stability, microbiological strategies, quality attributes, commercial manufacturing support, and investigations related to analytical trends, deviations, and product quality issues.
• Establish and maintain robust analytical methods through risk-based qualification, validation, lifecycle management, continuous improvement, troubleshooting, performance monitoring, revalidation, and enhancement of method robustness and efficiency.
• Lead stability and specification strategies across the product lifecycle, ensuring analytical data support shelf life, storage conditions, regulatory commitments, product release, and commercialization objectives.
• Integrate analytical, formulation, process, and manufacturing knowledge to support technology transfer, comparability assessments, change management, and oversight of external analytical laboratories and partners.

Skills

HPLC/UPLC

LC-MS

SE-HPLC

Regulatory knowledge

cGMP knowledge

CRO/CMO management

Mentoring staff

Cross-functional leadership

Project management

Analytical leadership

Job description

Kailera is seeking a Director, Analytical Development and Quality Control to lead analytical development, validation, and lifecycle management for sterile parenteral products, driving regulatory readiness and NDA support.

The ideal candidate brings 10+ years in pharma/biotech with HPLC/UPLC and LC-MS expertise, solid cGMP/regulatory background, and proven CRO/CMO management. Waltham, MA hub-based with remote options.