Principal Scientist

Overview

Pharmaceutical Science and Technology (PS&T) is the organization within Global Quality Management and CMC Technical Operations responsible for CMC activity across the product lifecycle for Bausch Health.

We are seeking an experienced and versatile Principal Scientist to join our CMC PS&T team. The specific role involves conducting CMC due diligence of both in-licensed or acquired drug products for EMEA region and subsequently, as part of a dedicated launch team, providing technical and scientific leadership ensuring “right first time” launch per established project timelines. The role also requires post-launch technical monitoring / product stewardship, to ensure each product is meeting key quality & supply metrics. As the new product opportunities will be diverse, the ideal candidate will be a subject matter expert with deep, direct experience in solid oral, semi solid & parenteral dosage forms. An in-depth knowledge of all applicable and relevant Regulatory Guidelines is essential in addition to proficiency in statistical analysis, preferably using the JMP statistical application.

Key Responsibilities

1. CMC technical support for in-licensing and acquisitions:

• Function as a key technical expert in the due diligence process for in-licensing and acquisition opportunities, providing go / no go recommendations to Business Development, based on documented and data-based analysis.
• Evaluate the robustness of development data, manufacturing processes for both Drug Substance (DS) and Drug Product (DP), and control strategies, highlighting risks and proposing mitigation strategies aligned with regulatory and launch timelines.
• Perform and report statistical analysis of drug product data to establish performance metrics and trends. Use the information obtained to both objectively and scientifically determine mitigation strategies.
• When applicable based on product development lifecycle, provide technical input to / author Module 3-related responses to Health Authority inquiries. Provide written technical justifications for regulatory proposals or regulatory submissions related to externally manufactured products.
• Ensure technical elements of launch process and controls are aligned with the approved dossier considering any scale up / raw material changes required or planned.
• Identify ways and/or utilize existing operational excellence tools to improve launch process efficiency.
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2. CMC Post-Marketing Requirements:

• Lead and manage CMC-related post-approval commitments and life-cycle management projects.
• Design and execute development studies to support process improvements, regulatory variations, and responses to health authority inquiries.
• In consideration of Regulatory framework, collaborate with External Manufacturing Organizations (EMOs) and internal stakeholders regarding assessment and implementation of product / process changes ensuring established launch timelines are met.
• Contribute scientific guidance during process/product deviations, out-of-trend / out-of-specification investigations and product complaints for products manufactured at EMOs.

3. Scale-up and/or Technology Transfer of newly acquired assets:

• Plan and lead the tech transfer of newly acquired or in-licensed products from external partners to internal or third-party EMOs.
• Oversee process scale-up from laboratory to pilot and commercial scale for both drug substance and drug product, ensuring successful validation and regulatory compliance.
• Troubleshoot and resolve complex technical issues arising during technology transfer and scale-up activities.

4.SOP / Guidance documents

• In collaboration with all relevant stakeholders, creates / revises policies and SOPs associated with technical aspects of due diligence and launch readiness.
• Conducts all other activities and decision making in accordance with existing Company policies and SOPs.

Qualifications & Experience

Required:

• Ph.D. in Pharmaceutical Sciences, Chemical Engineering, Chemistry, or a related field with a minimum of 8+ years of relevant industry experience; or M.S. with 12+ years of experience.
• Extensive and hand-on experience in small molecule drug product development is essential, with experience in parenteral, solid oral and semi solid dosage forms (including modified release technologies).
• Broad, end-to-end CMC experience supporting assets from Phase I through Phase III and regulatory submission (NDA). Direct experience authoring CMC sections for INDs and NDAs.
• Experience in supporting due diligence, licensing, and acquisition activities from a technical perspective.
• Knowledge of analytical chemistry and its application to the characterization and analysis of DS and DP (e.g., HPLC/UPLC, dissolution, GC, spectroscopy, solid-state characterization).
• Demonstrated experience in process scale-up and technology transfer to GMP manufacturing facilities.
• Comprehensive understanding of global CMC regulatory requirements (FDA, EMA, ICH).
• Excellent project management, communication, and leadership skills with the ability to influence cross-functional teams and external partners.
• Practical experience conducting statistical analysis of pharmaceutical data is essential, preferably using JMP stability application.

Preferred (will be a plus):

• Experience with biologic product development (DS/DP) and a successful BLA submission.
• Experience with other complex dosage forms (e.g., transdermal, inhalation & topical).
• Knowledge of combination product development (e.g., auto-injectors, delivery systems).
• Familiarity with Quality by Design (QbD) principles and Design of Experiments (DoE).
• Experience with Nitrosamines, associated Regulatory landscape, the application of CPCA framework and mitigation strategies.