Senior Director, Analytical Sciences – Biologics & Enzymes

Anagram Therapeutics, Inc.; Natick (MA); Hybride; USD 150 000 - 210 000; Plein temps

Avantages offerts par ce poste

Equity

Medical and dental benefits

401(k)

Résumé du poste

Headquartered in Natick, MA, Anagram Therapeutics is seeking a Head of Analytical Sciences to lead analytical development and control strategy across three spray-dried enzymes and the ANG003 combination product. You will design phase-appropriate analytical strategies, oversee method development, validation, and transfer, and ensure data integrity for regulatory submissions.

You will manage outsourced work with CDMOs/CROs, collaborate with MSAT, Quality, and Formulation, and mentor a four-person

Qualifications

• Requires 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).
• Experience with assay development and validation for protein-based therapeutics (e.g., SEC, CE, ELISA, activity assays, IEX, MS, HOS).
• 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.

Responsabilités

• 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.

Connaissances

Analytical leadership

Outsourced analytics management

Cross-functional collaboration

Regulatory interactions

CMC readiness

Formation

PhD or MS in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences, or related

Description du poste

The Head of Analytical Sciences will serve as the functional leader for all analytical development and control strategy efforts across Anagram Therapeutics' enzyme-based product platform. This role is critical to advancing product and process understanding across both drug substance and drug product, ensuring method robustness, driving phase-appropriate control strategies, and enabling regulatory and commercial success. The scope includes analytical support for three spray-dried enzymes and the combination drug product (ANG003) as well as multiple pipeline-stage candidates.

This is a build-and-lead role for someone excited by the challenge of designing and scaling analytical capabilities in a predominantly virtual, phase-appropriate development model, while working with external CDMOs, CROs, and strategic partners.

Responsibilities:

Functional Leadership

• 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.

External Network & Oversight

• 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.

People & Systems

• 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.

Regulatory & Compliance Support

• 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.

About You:

• 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.

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 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.

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.

Together, we are working to improve the lives of people living with malabsorption syndromes and nutrient metabolism disorders.