Anagram Therapeutics, Inc. · 18 hours ago
Head of Analytical Sciences
Natick, MA
Full-time
Onsite
Director/Executive
10+ years expAnagram Therapeutics, Inc. is focused on advancing enzyme-based product platforms, and they are seeking a Head of Analytical Sciences to lead analytical development and control strategy efforts. This role involves overseeing method development, managing external partnerships, and ensuring regulatory compliance to support clinical-stage programs.
BiotechnologyTherapeutics
Hiring Manager
Lauren O'Neil
Responsibilities
Provide strategic and technical leadership of Analytical Sciences across drug substance and drug product for all clinical-stage programs
Oversee method development, qualification, validation, and transfer, including legacy method remediation as needed
Develop and maintain the phase-appropriate analytical strategy aligned with clinical development and regulatory expectations
Establish analytical frameworks to drive comparability, forced degradation studies, and molecular characterization across three biologic enzymes
Champion the development of stability-indicating methods, impurity profiling, and release specification setting
Build a robust foundation for long-term product understanding that supports PPQ and eventual commercialization
Manage outsourced analytical work conducted at CDMOs and CROs, ensuring timelines, data integrity, and compliance
Lead technical troubleshooting and resolution in collaboration with external partners and internal functions (MSAT, Quality, Formulation)
Represent Analytical Sciences in CMC workstreams, regulatory interactions, and cross-functional development meetings
Champion analytical capability expansion, including instrumentation strategy, equipment acquisition and qualification, method lifecycle management, electronic notebook implementation, and integration of data acquisition and reporting systems
Grow and mentor a lean, high-performing internal team (initially 4 FTEs), while leveraging expert consultants and vendors
Build scalable systems and documentation practices to ensure continuity, knowledge transfer, and regulatory readiness
Author and review analytical sections of regulatory filings (IND, amendments, briefing documents)
Ensure that analytical work supports Q5E comparability justifications, stability strategies, and CMC readiness for pivotal trials
Qualification
Required
PhD or MS in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences, or related discipline
10–15+ years of progressive experience in biopharmaceutical analytical development, with strong understanding of biologics (proteins, enzymes, peptides)
Direct experience with assay development and validation for protein-based therapeutics (e.g., SEC, CE, ELISA, activity assays, IEX, MS, HOS techniques)
Proven success managing outsourced analytical activities and navigating external partnerships (CDMOs/CROs)
Demonstrated ability to develop control strategies and comparability justifications in line with FDA/ICH guidance
Familiarity with cGMP expectations and quality-by-design (QbD) principles
Preferred
Experience supporting clinical development from early to pivotal stages, including IND-enabling and Phase 2/3 readiness
Exposure to enzyme therapeutics or multi-component biologic drug products
Prior small company or startup experience, with a hands-on, solutions-driven mindset
Benefits
Medical
Dental
Short- and long-term disability
AD&D
401(k) retirement plan
Employee Referral Program
Company
Anagram Therapeutics, Inc.
Anagram is a clinical stage company leveraging proprietary enzyme technologies and expertise in gastrointestinal diseases to solve complex problems and advance a pipeline of products that can make a life-changing impact for people and their families living with cystic fibrosis and other rare diseases.
11-50 employees
Funding
Current Stage
Early StageLeadership Team
Robert Gallotto
President and Chief Executive Officer
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