Scientist, Analytical Development
Location: Natick, MA
About the Role:
Anagram Therapeutics is seeking a hands-on, collaborative analytical scientist to join our Analytical Development team as we advance multiple enzyme-based therapeutics toward pivotal trials. This lab based role offers broad method development and method lifecycle management opportunities across an array of assay types - including enzyme activity, ELISA, gel electrophoresis, and chromatography. The successful candidate will support programs from early-phase development through late-stage readiness, ensuring method robustness and phase-appropriate validation.
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.
Responsibilities:
- Support the method lifecycle management of analytical assays across all four enzyme products and associated drug product presentations, in alignment with ICH Q14 principles.
- Assist in 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 program/enzyme, 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.
- Draft and review method documentation, qualification/validation protocols, and analytical technical reports.
- 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.
About You:
Knowledge & Experience:
- Knowledge in enzyme therapeutics or multicomponent formulations.
- Background in enzymology or analytical characterization of enzymes.
- Experience with western blot method development.
- Familiarity with data integrity principles, electronic lab notebook (ELN) systems, and trending/visualization tools (e.g., JMP, Spotfire).
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:
- MS or PhD in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences, or a related field.
- 3–5 years (PhD) or 5–8 years (MS) of relevant industry experience in analytical method development for biologics or complex protein-based products.
- Strong technical proficiency in assay formats relevant to enzyme products, including but not limited to activity assays, ELISA, western blot, HPLC, biophysical assays (DLS/DSF), and spectrophotometric methods.
- Hands-on experience managing outsourced method development, testing, and troubleshooting at CDMOs or CROs.
- Experience with method lifecycle management: from early development through transfer and qualification, with familiarity in Q14/Q2(R2) frameworks is a plus.
Working at Anagram:
- Fast-paced environment – Thriving in an environment of change and continuous improvement is a core competency for all members of our team.
- Dynamic roles – We are a small and tight-knit team enthusiastically tackling difficult problems. All team members are expected to contribute to company protocols, provide feedback and to generally think critically about our processes.
- High expectations – We have big goals for the future. We expect dedication and positive collaboration from all our team to achieve them.
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
Together, we are working to improve the lives of people living with malabsorption syndromes and nutrient metabolism disorders.
