Associate Director, Head of Analytical Science and Technology (ASAT)

this opportunity-posted about 3 hours ago

Full-time • Manager

Milford, MA

5,001-10,000 employees

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About this opportunity : We are seeking a highly experienced and scientifically accomplished Associate Director to lead the Analytical Science and Technology (ASAT) team within our Quality Control (QC) organization. This newly established role is pivotal in bridging QC and Analytical Development (AD) functions and will serve as a key driver for the successful technical transfer, deployment, and lifecycle management of analytical methods for oligonucleotide-based drug substances and intermediates.

Lead the ASAT team to support analytical method transfer from clients or AD to QC, ensuring readiness for GMP release and stability testing.
Serve as the primary technical liaison between QC, AD, and client analytical groups for method transfer, performance issues, and investigations.
Design and deliver technical training programs for QC analysts in oligonucleotide analytical techniques, such as LC, LC-MS, CE, and UV.
Lead or support the technical evaluation and resolution of deviations, OOS, and OOT results, including experimental hypothesis testing and root cause analysis.
Ensure scientific rigor and regulatory compliance in method validation, qualification, and transfer activities in alignment with ICH and client expectations.
Provide expert troubleshooting in chromatographic and mass spectrometric methods, including impurity profiling and data integrity assessments.
Support implementation of analytical lifecycle management practices and continuous improvement within QC.
Drive collaborative problem-solving across functional areas such as Manufacturing, QA, and Project Management.
Support client audits and regulatory inspections as a subject matter expert (SME) in analytical technologies and method transfer processes.
Lead, coach, and develop the ASAT team, fostering technical excellence, accountability, and continuous professional growth through mentorship and structured development planning.
Establish and monitor key performance indicators (KPIs) to measure individual and team performance, drive continuous improvement, and ensure alignment with departmental and organizational objectives.

Ph.D. in Chemistry, Biochemistry, Pharmaceutical Sciences, or a related discipline.
Over 10 years of combined experience in the pharmaceutical or biotechnology sectors, or in academic research, including a minimum of 3 years in the industry - preferably within a CDMO analytical development or quality control (QC) environment.
Extensive experience with testing methods for oligonucleotide therapeutics, including characterization, impurity profiling, and potency assays.
Demonstrated ability to quickly learn and adapt to new testing platform technologies, with a proactive approach to mastering innovative analytical tools and methodologies.
Advanced expertise in LC-MS, including method development, optimization, and troubleshooting for both small and large oligonucleotide molecules.
Hands-on knowledge of major instrumentation and data systems, such as Agilent, Waters, and ThermoFisher LC systems and their software.
Proven ability to lead investigations involving OOS/OOT and deviations using scientifically sound and compliant approaches.
Strong technical writing skills.
Demonstrated ability to lead technical teams, develop talent, and communicate complex scientific topics clearly to technical and non-technical stakeholders.
Experience working with GMP regulations, ICH guidelines, and familiarity with expectations from regulatory agencies (FDA, EMA, etc.).
Excellent interpersonal skills and a strong client service mindset.

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Associate Director, Head of Analytical Science and Technology (ASAT)

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