Assignment Description:
We are looking for a Senior Technology Transfer & Industrialization Project Manager to join our dynamic team.
What you will work on:
- Implement industrialization plans and programs, supporting policies and practices related to the manufacturing and industrialization of new product introduction (NPI) projects from prototype to final production.
- Drive industrialization activities to ensure smooth transition of products from R&D to full production readiness, representing MS&T in technology transfer projects.
- Develop and execute industrialization plans related to product assembly, programming, and testing procedures, and define requirements for automated production test benches.
- Collaborate closely with engineering teams to ensure that product designs optimize manufacturability, assembly efficiency, cycle time, reliability, and serviceability.
- Lead and coordinate end-to-end technology transfer processes from R&D to production or across sites, ensuring complete documentation, training, and process readiness.
- Develop and manage detailed project plans, timelines, milestones, and risk assessments for technology transfer activities.
- Track project progress, manage deliverables, and address roadblocks to ensure timely and successful completion of activities.
- Oversee documentation related to technology transfer, including SOPs, batch records, and validation protocols, ensuring compliance with regulatory standards (e.g., FDA, EMA, GMP).
- Collaborate with quality assurance and engineering teams to validate and qualify new equipment and processes.
- Coordinate subject matter experts across Development, MS&T, Engineering, and other site functions to ensure seamless collaboration and alignment.
- Provide technical support during scale-up and commercialization, identifying and resolving process challenges efficiently.
- Ensure operational teams are trained on new processes, technologies, and equipment, providing ongoing technical guidance and support.
- Lead continuous improvement initiatives to enhance technology transfer efficiency, product quality, and overall process performance.
What you bring:
- Bachelor’s, Master’s, or PhD in Chemistry, Biochemistry, Chemical Engineering, or a related field, with approximately 6–10 years of experience in pharmaceutical, biopharmaceutical, or manufacturing environments.
- Proven experience leading technology transfer projects within regulated industries.
- Strong knowledge of GMP guidelines, regulatory standards, and quality systems.
- Excellent project management skills with the ability to handle multiple complex projects simultaneously.
- Strong analytical, problem-solving, and organizational skills with high attention to detail.
- Effective leadership and communication skills, with the ability to collaborate across diverse functional teams.
- Expertise in risk management, validation processes, scale-up methodologies, and process optimization.
- Preferably certified in Project Management (e.g., PMP) and/or trained in Lean or Six Sigma methodologies.
- Experience working within pharmaceutical or biopharmaceutical manufacturing environments.
If this sounds interesting, please send your CV to cv@veritaz.se
