Associate Director, Head of Analytical Science and Technology (ASAT) jobs in United States
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Nitto Avecia · 2 days ago

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

positionMilford, MA
timeFull-time
remoteOnsite
senioritySenior Level, Lead/Staff, Director/Executive
money$154K/yr - $189K/yr
date10+ years exp

Nitto Avecia is seeking a highly experienced Associate Director to lead the Analytical Science and Technology (ASAT) team within their Quality Control organization. This role is crucial for bridging QC and Analytical Development functions and involves overseeing the technical transfer and lifecycle management of analytical methods for oligonucleotide-based drug substances.

BiotechnologyManufacturingPharmaceutical
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H1B Sponsor Likelynote

Responsibilities

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

Qualification

Ph.D. in ChemistryLC-MS expertiseOligonucleotide testing methodsGMP regulations experienceTechnical writing skillsClient service mindsetInterpersonal skillsTeam leadership

Required

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

Company

Nitto Avecia

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Oligonucleotides are giving rise to a new generation of therapeutics—and Nitto Avecia is helping lead the way.
dateFounded in 1995
location
Milford, Massachusetts, USA
people-size501-1000 employees
web-link
http://www.avecia.com

H1B Sponsorship

Nitto Avecia has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (4)
2024 (7)
2023 (6)
2022 (10)
2021 (11)
2020 (5)

Funding

Current Stage
Late Stage
Total Funding
unknown
2011-02-03Acquired
Company data provided by crunchbase