Senior Engineer, Process & Packaging Development

Responsibilities

• Manage and support collaboration between R&D and third-party manufacturing partners, bridging the gap between research and commercial production.
• Drive the development of innovative manufacturing processes and packaging systems for drug products, particularly those related to addiction therapy, from clinical trials through tech transfer to commercial-scale production.
• Assist in the evaluation and management of contract manufacturers, research organizations, and suppliers as needed.
• Lead the coordination between R&D and commercial supply chains for both new and existing products.
• Develop engineering protocols for in-house or third-party manufacturing processes.
• Oversee technology transfers of drug product manufacturing from R&D to commercial facilities for clinical trials and commercialization, ensuring all processes, including scaling, packaging, controls, and validation, are successfully managed.
• Contribute to post-approval product changes, ensuring proper technical oversight from CMC SMEs.
• Develop and revise SOPs, protocols, and reports in support of technology transfer and clinical manufacturing processes.
• Ensure comprehensive tech transfer files that maintain technical knowledge of products manufactured internally or by external partners, safeguarding product quality and ongoing process ownership.
• Work with Quality and Supply teams to ensure reliable and safe delivery of clinical supplies, maintaining cGMP standards.
• Manage projects to meet established milestones, ensuring timely and accurate project delivery.
• Lead strategic manufacturing meetings, risk assessments, and cross-functional discussions to drive decision-making and minimize risks.
• Implement Quality by Design principles in the development process.
• Draft sections for regulatory submissions related to manufacturing and packaging.
• Assess and define specifications for raw materials and components, ensuring they meet the required quality standards.
• Manage third-party vendors to ensure adherence to timelines and quality expectations.
• Thrive in a fast-paced environment, delivering high-quality work on complex projects.
• Troubleshoot and resolve technical issues swiftly to maintain project momentum.
• Apply innovative, lateral thinking to solve complex problems, providing justifications and solutions for challenging situations.
• Oversee manufacturing development activities from early-phase drug development through to regulatory approval and post-launch.

Qualifications