What You'll Do:

The Scientist I, Analytical Development and Quality Control is an experienced scientist within the Analytical Development and Quality Control (AD/QC) organization, with a primary focus on analytical quality control, method validations, stability programs, and data integrity. This role applies broad knowledge of analytical principles and QC practices to support release and stability testing, data trending, and lifecycle management of analytical methods.

The Scientist I is responsible for analyzing and interpreting stability and release data, identifying trends and potential quality risks, and applying a foundational understanding of degradation pathways to ensure product quality over time. This individual contributes to the maintenance and integrity of analytical data systems, including LIMS and stability databases, and ensures compliance with regulatory expectations and internal quality standards.

Required location: Waltham, MA (hub-based, onsite 3-4 days per week)

Responsibilities:

• Analyze and trend release and stability data to identify variability, shifts, and emerging quality risks, and communicate findings to departmental leadership and project teams
• Review release and stability test results to ensure accuracy, completeness, and compliance with specifications, procedures, GMP requirements, and overall data integrity
• Execute and support registration stability programs, including protocol implementation, sample management, and data evaluation across timepoints
• Apply scientific understanding of degradation pathways to interpret analytical data for trending purposes, and support investigations (OOS, OOT, deviations) and CAPA analysis
• Maintain and ensure integrity of data within LIMS and stability databases, ensuring accurate data entry, traceability, and audit readiness
• Conduct data integrity reviews and assessments in alignment with ALCOA+ principles, identifying gaps and supporting remediation actions as needed
• Author and review analytical reports and regulatory documentation, including sections supporting stability, specifications, and method performance
• Design and execute analytical experiments to support method lifecycle activities, including development, qualification/validation, transfer, or troubleshooting
• Collaborate with cross-functional teams to communicate data insights, support investigations, and contribute to project milestones and regulatory submissions
• Experience with data analysis tools (e.g., Excel advanced functions, JMP, or statistical software) for trending and visualization
• Working knowledge of ICH guidelines and regulatory expectations for analytical methods and stability programs
• Evaluate temperature excursions for stability and release samples, assessing potential impact on product quality using scientific judgment, stability data, and relevant regulatory/technical guidance

Required Qualifications:

• 8+ years of hands-on experience with analytical techniques (e.g., HPLC/UHPLC, LC-MS, GC, compendial tests) supporting release and/or stability testing
• Experience trending and interpreting stability and QC data, with a working understanding of degradation pathways and stability-indicating methods
• Proficiency with LIMS and laboratory data systems, along with a strong understanding of data integrity principles (ALCOA+) and regulatory expectations
• Strong technical writing and communication skills, including experience reviewing analytical data and contributing to reports or regulatory documentation
• Demonstrated collaboration and problem-solving skills, with the ability to manage multiple priorities in a fast-paced, quality-focused environment

Preferred Qualifications:

• Experience supporting regulatory submissions (e.g., IND, NDA, BLA) with analytical or stability sections
• Familiarity with stability program design and lifecycle management in a pharmaceutical or biotechnology setting
• Experience participating in or supporting regulatory inspections and audits
• Exposure to method development, qualification/validation, or transfer activities within Analytical Development or QC
• Advanced degree preferred

Education:

• Bachelor's, Master's, or Ph.D. in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences, or a related discipline within a GMP-regulated environment

Salary Range

$106,000-$130,000 USD

For Full Time Roles: This range represents the company's good-faith estimate of the salary at the time of posting. Actual pay may vary based on experience, skills, qualifications, location, and internal equity. We also offer comprehensive health coverage, flexible time off, paid holidays, and a year-end shutdown. Enjoy a monthly wellness stipend, generous 401(k) match, tuition reimbursement, commuter benefits, disability and life insurance, plus annual bonus opportunities and equity grants-because your well-being and future matter to us.

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