Scientist - Process Development, Drug Substance Lifecycle

Scientist – Process Development, Drug Substance Lifecycle

Position Summary:

This role will manage the lifecycle of drug substance programs through development, validation and manufacturing into late stage. The candidate leads interdisciplinary subject‑matter expertise during commercialization, provides technical support during regulatory agency inspections, process characterization, validation, commercial program maintenance, and drives lifecycle improvements.

• Work cross‑functionally with Manufacturing Sciences & Technology, Manufacturing, Quality Assurance, Quality Control, Project Management, and other departments to ensure the success of a molecule’s lifecycle.
• Author and review process characterization protocols and reports.
• Own the process knowledge of the biologic product throughout the development and validation life cycles; perform data analysis of historical batches to drive process characterization experimental design.
• Maintain oversight of process capability through data trending and statistical analysis of critical variables; ensure processes are robust, continue validation and improve continuously.
• Prepare and review content for client meetings with a focus on data analysis and adherence to program timelines.
• Provide technical leadership on strategic initiatives including tech transfers, process validation, technical reports, data analysis, process monitoring, product comparability, and second line support of technical/scientific process and analytical issues.
• Drive lifecycle improvements considering impact on filing, critical attributes and specifications.
• Act as technical lead for validation process risk assessments and support deviations, CAPAs including root‑cause analysis and corrective action identification.
• Train, coach and mentor others on early and late phase molecule lifecycle, personnel development and business challenges.
• Provide technical content for key documents such as PPQ or comparability assessments, Control Strategies, Validation Plans, at‑scale study protocols and author content for regulatory submissions.
• Present technical strategies during major health authority interactions and inspections.
• Lead or support continuous improvement initiatives to increase revenue, throughput or other key performance metrics for the site and network.

• PhD in STEM or related field with at least 8 years of biopharmaceutical process development or manufacturing experienceORMS in STEM or related field with at least 12 years of biopharmaceutical process development or manufacturing experience ORB.S./B.A. in STEM or related field with at least 15 years of biopharmaceutical process development or manufacturing experience.
• Demonstrated excellence in prior roles may substitute for the minimum years of experience.
• Knowledge of drug substance lifecycle management, especially biologics process development and manufacturing.
• Experience interacting and liaising with internal and external clients, customers and suppliers.
• Experience in late‑phase, process characterization, process performance qualification, and commercial programs.
• Experience in product/process CMC lifecycle management including pre‑approval, launch and post‑approval stages is preferred.
• Experience working in biologics process development and supporting cGMP manufacturing.

• Defined career path and annual performance review and feedback process.
• Diverse, inclusive culture.
• Positive working environment focusing on continually improving processes.
• Potential for career growth on an expanding team.
• 152 hours PTO + 8 paid holidays.
• Generous 401(k) match.
• Medical, dental and vision benefits effective day one.
• Tution Reimbursement.

Catalent is an Equal Opportunity Employer, including disability and veterans. If you require reasonable accommodation for any part of the application or hiring process due to a disability, please request accommodation by contacting Disabili, including the job number, title and location.