Head of Formulation Development

Location: Natick, MA

About the Role:

Anagram Therapeutics is seeking an accomplished, hands-on leader to serve as Head of Formulation Development, responsible for advancing our enzyme-based therapeutics into scalable, patient-friendly oral presentations. This role will lead formulation strategy and execution across drug substance and drug product interfaces — including spray dry development, solid oral dose (SOD/OSD) design, and packaging system development.

The ideal candidate brings a blend of technical excellence and development judgment, with the ability to operate strategically while building and guiding a lean, high-impact team. This is a foundational leadership role with direct impact on go-to-market readiness for both lead and pipeline programs.

The position reports to the COO and is located in Natick, MA.

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.

About You:

• 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.

Personal Attributes:

Execution: Demonstrates and fosters a winning mind set, a sense of urgency, optimism, and ownership, and a strong drive to achieve goals and organizational success. Delivers business results for the organization. Accountable for effectively and efficiently completing work responsibilities and tasks with high quality. Demonstrates initiative, works to achieve results, meets or exceeds goals, and acts on opportunities to create value.

Collaboration: Promotes collaboration and works effectively with others across the organization to achieve goals. Demonstrates proficient cross-cultural communication and collaboration in all interactions. Credits others for their contributions and accomplishments.

Communication: Prepares and delivers clear, concise, accurate, effective, and persuasive written and verbal materials/messages. Attentively and accurately listens to others. Promotes a free and timely flow of high-quality information between self and others and across the organization; encourages the open expression of ideas and opinions.

Adaptability: Responds resourcefully, flexibly, and positively when faced with new challenges and demands. Willingly and effectively deals with the stress and complexities of various situations. Moves forward productively under conditions of change or uncertainty.

Education and Experience:

• 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.

About Us:

Headquartered in Natick, MA, we have all the perks you can find in Cambridge (short distance to lunch, shopping, etc.) and more perks that you can't:

• Ample free parking
• Easy/quick access to Route 9 and Mass Pike (equal distance to Route 495 or Route 95/128)

Anagram Therapeutics offers competitive compensation, including equity, and a comprehensive benefits package that includes medical, dental, short- and long-term disability, AD&D, 401(k) retirement plan, and an Employee Referral Program.

We are an equal employment opportunity employer and do not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law.

careers@anagramtx.com