Anagram Therapeutics, Inc. · 1 day ago
Head of Formulation Development
Natick, MA
Full-time
Onsite
Director/Executive
10+ years expAnagram Therapeutics is a company focused on advancing enzyme-based therapeutics, and they are seeking a Head of Formulation Development to lead formulation strategy and execution. This foundational leadership role involves overseeing the development of scalable, patient-friendly oral presentations and collaborating with various departments to ensure successful product development.
BiotechnologyTherapeutics
Hiring Manager
Lauren O'Neil
Responsibilities
Provide strategic and technical leadership for formulation development of enzyme-based products, including spray-dried intermediates, oral tablet design, and packaging system integration
Lead pre-formulation and formulation studies to support stability, manufacturability, and performance of multi-enzyme combination products
Design and oversee the development of fit-for-purpose formulations for clinical and commercial use, considering scale-up, patient adherence, and regulatory expectations
Direct the development and characterization of spray-dried drug substances, including excipient selection, performance testing, and compatibility assessments
Lead tablet formulation development, including blend behavior, compression optimization, flow properties, coating strategies, and packaging configuration
Collaborate with Process Development, Analytical Sciences, MSAT, and Regulatory to align on control strategies, comparability, and phase-appropriate CMC deliverables
Serve as primary technical lead for formulation development at CDMOs — including authoring technical documents, reviewing protocols and reports, and overseeing execution
Contribute to the preparation of CMC regulatory submissions, including INDs, CTAs, briefing packages, and eventually BLA components
Support evaluation and selection of clinical and commercial manufacturing and packaging partners
Travel up to 40%, including international travel, to oversee external laboratory and manufacturing site activities
Qualification
Required
PhD or MS in Pharmaceutics, Pharmaceutical Sciences, Chemistry, or related field
10–15+ years of formulation experience, with at least 5 years in a leadership or program-facing role
Strong track record of developing oral protein or peptide formulations, ideally including spray drying and tableting
Experience overseeing CDMOs and external partners for formulation, manufacturing, and packaging development
Prior experience contributing to CMC regulatory submissions and supporting health authority interactions
Strong understanding of formulation strategies for complex or sensitive active ingredients, including proteins, peptides, or enzyme-based therapeutics
Proven expertise in spray drying development, including excipient screening, process optimization, and performance testing
Experience with oral solid dose (OSD) design, particularly tablets — including blend properties, tableting, coating, and dissolution strategies
Familiarity with packaging system development, including material compatibility, stability considerations, and device integration (e.g., bottle vs. blister)
Strong working knowledge of CMC development from early-phase through commercial launch
Comfortable leading cross-functional initiatives and serving as the key formulation interface with external development and manufacturing partners
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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