Senior Director, Analytical Development and Quality Control

This is a fully remote position, open to applicants in Massachusetts.

📋 Description

• Develop the long-term analytical development and quality control strategy, operating model, governance framework, and external partner network for the biologics portfolio.

• Direct analytical development and quality control initiatives for protein therapeutics from candidate selection through late-stage clinical development and readiness for commercialization.

• Create phase-appropriate analytical control strategies, including method development, qualification, validation, specifications, comparability assessments, stability programs, and management of reference standards.

• Act as the senior enterprise analytical and QC leader, providing counsel to Technical Operations, Quality, Regulatory, CMC, and executive management.

• Build and oversee the analytical organization, leading heads of Analytical Development and Quality Control.

• Supervise CDMOs, contract testing facilities, and external analytical collaborators.

• Function as the primary analytical and QC representative on cross-functional CMC teams.

• Collaborate with Process Development, MS&T, Quality Assurance, Regulatory Affairs, and Supply Chain to ensure manufacturing readiness, product quality, and lifecycle management.

• Lead analytical support for technology transfers, process modifications, comparability evaluations, process characterization, and validation readiness.

• Review and endorse technical and GMP documentation, analytical methods, specifications, protocols, reports, validation documents, and regulatory submission materials.

• Provide hands-on leadership during manufacturing campaigns and quality incidents, including batch data analysis, investigations, deviations, OOS/OOT results, CAPAs, and change controls.

• Promote inspection readiness and adherence to global regulatory standards, cGMP, data integrity principles, and company quality benchmarks.

• Contribute to IND, BLA, IMPD, and other regulatory submissions while supporting interactions with health authorities.

• Establish and track KPIs for external partners and initiatives for continuous improvement.

• Oversee departmental budgets, resource allocation, and external expenditures.

• Advocate for emerging analytical technologies and innovative methodologies.

• Recruit, cultivate, and retain a high-performing analytical and QC team; mentor leaders and encourage cross-functional collaboration.

⛳️ Requirements

• Ph.D. in Biochemistry, Analytical Chemistry, Pharmaceutical Sciences, Molecular Biology, Chemical Engineering, or a related scientific field, with over 15 years of pertinent industry experience; alternatively, an M.S. with considerable additional relevant industry experience.

• Profound expertise in analytical development and quality control for biologics, encompassing monoclonal antibodies, recombinant proteins, fusion proteins, and complex protein therapeutics.

• Proven success in developing and executing phase-appropriate analytical strategies from candidate selection through late-stage clinical development and commercialization readiness.

• Extensive background in analytical method development, qualification, transfer, validation, lifecycle management, and control strategies for biologic drug substances and products.

• Strong comprehension of protein characterization techniques, including chromatography, electrophoresis, spectroscopy, potency, binding, purity, size variant, charge variant, and stability-indicating methodologies.

• Experience in establishing specifications, comparability strategies, stability programs, and reference standard initiatives.

• Leadership experience in building, mentoring, and developing analytical and quality organizations within biotechnology or pharmaceutical settings.

• Experience in leading teams and nurturing senior technical talent in a lean, high-accountability environment.

• Significant experience managing CDMOs, contract testing laboratories, and external analytical collaborators in an outsourced development and manufacturing context.

• Strong grasp of GMP regulations, data integrity, quality systems, deviations, investigations, CAPAs, change controls, OOS/OOT management, and inspection readiness.

• Experience supporting technology transfers, process characterization, manufacturing investigations, process validation readiness, and lifecycle management.

• Proven track record of authoring, reviewing, and defending analytical and QC content for INDs, BLAs, IMPDs, and responses to health authorities.

• Ability to convey complex scientific, regulatory, quality, and operational issues to executives, cross-functional stakeholders, regulatory agencies, and external partners.

• Business insight with experience in managing budgets, external expenditures, resource allocation, and prioritization across multiple programs.

• Strategic, proactive, hands-on leadership with strong collaboration, communication, and influencing capabilities.

🏝️ Benefits

• Eligibility for annual bonuses

• Equity compensation

• Competitive benefits package