Director, Analytical Method Sciences - Separations

Jobtailor

Harvard (MA)

On-site

USD 180,000 - 240,000

Full time

14 days+

Get more replies from employers

Send a job-specific resume in minutes.

Job summary

Jobtailor in the United States is seeking a senior leader to define and execute the strategic vision for the AMS Separations organization, building talent and capability across multiple products. You will guide analytical lifecycle management, regulatory interactions, and cross‑functional collaboration with Quality Control, Regulatory, Manufacturing, and Product Teams.

You will develop leaders, drive process improvements, and ensure alignment of commercial needs with analytical capabilities

Qualifications

PhD in Chemistry, Biochemistry, Biological Sciences, Pharmaceutical Sciences, or related field with 10+ years of industry experience; or MS or BS with 15+ years of industry experience.
Significant experience in analytical sciences supporting biologics development, commercialization, licensure, and lifecycle management.
Expertise in analytical characterization methodologies (SEC, CEX, CE-SDS, icIEF, peptide mapping, glycan analysis).
Experience developing, validating, transferring, and sustaining analytical methods.
Experience establishing lifecycle management and validation strategies aligned with industry best practices and global regulatory expectations.
Strong understanding of Quality Control operations, CGMP/GDP requirements, quality systems, and product quality investigations in regulated environments.
Experience authoring, reviewing, and supporting regulatory submissions, health authority interactions, and inspection readiness activities.
Proven success leading scientific organizations responsible for analytical lifecycle management, investigations, technical problem-solving, and commercialization support.
Demonstrated ability to build high-performing teams, develop scientific talent, and create organizational capability through coaching, succession planning, and strategic leadership.
Strong business acumen to translate organizational strategy into operational execution.
Strong leadership, communication, influencing, and stakeholder management skills.
Experience working across complex global matrix organizations.
Ability to lead through change, drive innovation and continuous improvement, and deliver sustainable business results.
Demonstrated people leadership experience leading scientific and technical organizations in regulated environments.
Experience in a commercial QC is a plus.

Responsibilities

Define and execute the strategic vision for the AMS Separations organization.
Build organizational capability through talent development, succession planning, workforce planning, performance management, and strategic hiring.
Develop future technical and people leaders and create a sustainable pipeline of scientific talent.
Establish priorities and allocate resources across multiple products, platforms, and business initiatives.
Drive organizational effectiveness, flexibility, simplification, and continuous improvement.
Foster accountability, collaboration, technical excellence, and innovation.
Provide strategic oversight and scientific direction for analytical lifecycle management, validation, transfer, comparability, remediation, and method performance monitoring.
Serve as the technical escalation point for complex scientific issues, analytical risks, and business-critical decisions.
Guide technical strategy and development of capabilities for evolving portfolio needs.
Coach and develop scientists in technical decision-making, problem-solving, and scientific leadership.
Partner with Quality Control, Analytical Development, MS&T, Regulatory, Manufacturing, and Product Teams.
Drive alignment between commercial needs, analytical capabilities, and resource planning.
Support regulatory submissions, inspections, audits, and health authority interactions.
Contribute to analytical CMC strategy and dossier authorship for licensure.
Contribute technical expertise to responses to Health Authority queries.
Drive organizational effectiveness, operational excellence, talent development, and strategic execution as a member of the AMS leadership team