Analytical Scientist

Anagram Therapeutics is seeking an experienced analytical scientist to lead and execute method lifecycle management across its enzyme-based therapeutic platform. The successful candidate will support programs from early-phase development through late-stage readiness, ensuring method robustness, phase-appropriate validation, and control strategy alignment for multiple drug substances and drug product presentations — including a spray-dried, single-tablet combination of three biologic enzymes.

The role emphasizes deep, hands‑on engagement with analytical methods (physicochemical and biological), data integrity, and technical oversight of outsourced testing. This position is ideal for a scientist who enjoys working across molecular and formulation boundaries to ensure fit‑for‑purpose analytical control throughout the product lifecycle.

• Lead the method lifecycle management of analytical assays across all four enzyme products and associated drug product presentations, in alignment with ICH Q14 principles.
• Support mechanism‑appropriate development of enzymatic activity assays, including kinetic design, substrate selection, and specificity/sensitivity optimization.
• Design and execute method development, optimization, transfer, qualification, and remediation strategies in collaboration with internal stakeholders and external labs.
• Serve as analytical technical lead for one or more programs, ensuring methods are scientifically robust and fit‑for‑purpose for release, stability, and in‑process control testing — including phase‑appropriate design, qualification, and transfer to QC organizations.
• Monitor and assess method performance using structured trending and data analysis approaches; drive method investigations and continuous improvement as needed.
• Draft and review method documentation, qualification/validation protocols, analytical technical reports, and regulatory submission content.
• Collaborate with Formulation Development, MSAT, and Quality teams to ensure assay fitness for process development, tech transfer, and clinical manufacturing.
• Participate in CDMO/CRO oversight: author method transfer protocols, review raw data, provide technical input into OOS/OOT investigations where root cause may involve method performance, design, or transfer execution.
• Support implementation and integration of electronic systems (e.g., ELN, LIMS, data repositories) as part of long‑term capability buildout.

• Experience with enzyme therapeutics or multicomponent formulations.
• Background in enzymology or analytical characterization of enzymes.
• Prior experience supporting INDs and clinical trial materials (CTM) release/testing.
• Familiarity with data integrity principles, electronic lab notebook (ELN) systems, and trending/visualization tools (e.g., JMP, Spotfire).

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.

• MS or PhD in…