AS&T Principal Scientist - CGT & Biologi

Job Description
General Summary:

The Principal Scientist will be part of Analytical Sciences and Technology (AS&T) team within Commercial Manufacturing & Technical Operations (CMTO) department. S/He/They will provide support with development and execution of the analytical CMC strategy by contributing to team goals, maintaining source data, and delivering high-quality technical documentation for late-stage and commercial Biologics and Cell and Gene therapy (CGT) programs.

Key Duties and Responsibilities:
Support preparation of global regulatory submission sections, for late-stage and commercial programs in analytical CMC areas (e.g., registrational CQAs, control strategy, justification of specifications, and comparability studies).
Author and/or review technical documents such as justification of specifications, method bridging, comparability and stability reports.
Assist with QMS activities (Change Control, Impact Assessment, Change Action Owner) related to CMC implementation.
Perform data verification, trending and statistical analysis to support regulatory strategy and product characterization.
Collaborate cross-functionally with internal stakeholders and external partners to support analytical readiness for commercialization and ongoing product lifecycle activities.

Knowledge and Skills:
Strong technical writing skills are essential; regulatory writing experience (e.g., eCTD Module 3 sections and/or responding to health authority responses) is highly desirable.
Experience in analytical CMC development for cell and gene therapy or biologics, particularly from late-stage development through commercialization.
Prior experience working with contract testing organizations (CTOs) or manufacturing sites (CDMOs) is a plus.
Familiarity with the GMPs, USP/ICH, and regulatory guidance applicable to analytical methods and commercial-stage CMC.
Strong understanding of analytical support for commercial biological products and cGMP manufacturing.
Proven ability to manage multiple priorities, meet timelines, and maintain flexibility in a fast-paced environment.
Effective collaboration, communication and multitasking skills.
Familiarity with... For full info follow application link.

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