Analytical CMC Specialist: Method Validation & Transfer

Initial Therapeutics, Inc.; Norwood (MA); On-site; USD 90,000 - 144,000; Full time

Benefits offered by this job

Health care benefits

Well-being resources

Paid time off

Retirement savings

Location-specific perks

Job summary

Moderna in Norwood, MA is seeking an analytical CMC professional to provide executional support for method-related activities across late-phase development and commercial programs. You will coordinate validation, transfer, verification, and lifecycle management with cross-functional teams and external partners.

The role emphasizes documentation, regulatory readiness, and quality systems to ensure traceability and inspection readiness. Collaboration and strong technical writing are essential.

Qualifications

• Bachelor’s degree in Chemistry, Biochemistry, Pharmaceutical Sciences, or a related scientific field.
• 3+ years of experience in Analytical Development, Quality Control, Analytical Sciences, or a related function within the biopharmaceutical industry.
• Experience supporting analytical method qualification, validation, transfer, and/or lifecycle management within a GMP-regulated environment.
• Working knowledge of analytical documentation requirements for regulatory submissions supporting late-phase or commercial programs.
• Familiarity with ICH guidelines, GMP regulations, and industry best practices.
• Strong technical writing, documentation, and organizational skills.
• Strong communication and collaboration skills with the ability to work effectively across cross-functional teams.

Responsibilities

• Provide project management and coordination support for analytical method-related activities across late-phase development and commercial programs, including maintaining timelines, trackers, action logs, deliverable lists, and status updates.
• Support planning, execution tracking, and follow-up for analytical method validation, transfer, verification, and lifecycle management activities to ensure alignment with internal expectations, regulatory requirements, and program milestones.
• Coordinate with internal laboratories, external testing partners, Quality, Regulatory CMC, and program teams to support timely execution of analytical method activities and resolution of documentation or data package gaps.
• Contribute to analytical method transfer activities across internal and external laboratories by supporting transfer planning, documentation preparation, protocol/report review, readiness tracking, and follow-up on open items.
• Author and revise analytical documentation, including validation plans and strategies, protocols, reports, transfer documents, method summaries, technical memos, gap assessments, and supporting documentation.
• Support lifecycle management of commercial analytical methods, including documentation updates, method governance support, change control documentation, continuous improvement activities, and tracking of post- implementation actions.
• Assist with compiling, organizing, and reviewing analytical documentation and data packages in support of regulatory submissions, health authority responses, post-approval commitments, and commercial readiness activities.
• Contribute to regulatory query responses by gathering technical inputs, coordinating cross-functional reviews and tracking deliverables through completion.
• Support analytical method gap assessments to identify documentation, validation, transfer, or lifecycle management needs for late-phase development, regulatory filing, and commercial implementation.
• Maintain well-organized records, trackers, and supporting documentation to promote traceability, inspection readiness, and effective knowledge management across analytical CMC activities.
• Support meeting preparation and follow-up, including agenda development, meeting notes, action item tracking, decision capture, and escalation of risks or delays to appropriate team members.
• Work within established quality systems and regulated documentation practices, ensuring that deliverables are accurate, complete, traceable, and compliant with applicable internal procedures.

Skills

Project management

Analytical method support

Cross-functional collaboration

Documentation and record-keeping

Regulatory compliance

Technical writing

Education

Bachelor's degree in Chemistry, Biochemistry, Pharmaceutical Sciences, or related field

Job description

Moderna in Norwood, MA is seeking an analytical CMC professional to provide executional support for method-related activities across late-phase development and commercial programs. You will coordinate validation, transfer, verification, and lifecycle management with cross-functional teams and external partners.

The role emphasizes documentation, regulatory readiness, and quality systems to ensure traceability and inspection readiness. Collaboration and strong technical writing are essential.