Position Overview: We are seeking a highly skilled and experienced Technical Transfer Lead to join our MS&T process team. The successful candidate will play a pivotal role in leading the technical transfer of cell therapy products, ensuring seamless transition from development to manufacturing, while maintaining compliance with Good Manufacturing Practices (GMP) standards. This position offers an exciting opportunity to contribute to the advancement of innovative cell therapy technologies.
Accountabilities:
Lead and coordinate the technical transfer activities for cell therapy products, overseeing the transfer process from research and development to manufacturing.
Collaborate with cross-functional teams to ensure successful execution of tech transfer projects, including process development, manufacturing, quality control, and regulatory affairs.
Develop and maintain comprehensive documentation related to technical transfer processes, ensuring compliance with GMP standards and regulatory requirements.
Provide technical expertise and guidance to resolve issues and challenges encountered during the transfer process, working closely with internal and external partners.
Contribute to the continuous improvement of tech transfer protocols, methodologies, and best practices to enhance efficiency and quality of transfer processes.
Qualifications:
BS degree required with >10 years' experience in a relevant scientific or engineering field MS or PhD preferred, PhD with > 5 years or MS with > 8 years.
Minimum of 3 years of experience in GMP environment, with a focus on technical transfer projects within the biopharmaceutical or cell therapy industry.
Demonstrated expertise in cell therapy technologies, process development, and manufacturing operations.
Strong understanding of regulatory requirements and quality standards related to cell therapy products.
Experience with biopharmaceutical unit operations, equipment, and plant automation/sensors.
Knowledge of cGMPs and experience supporting validation efforts related to cell therapery programs.
Proven ability to effectively lead and manage cross-functional teams, with excellent communication and interpersonal skills.
Primary liaison between the Manufacturing and Development departments.
Evaluate the impact of proposed changes to manufacturing systems.
Maintain the master project plan and schedule for assigned projects.
Prepare proposals, updates, and recommendations for senior management review.
Liaison with internal and external customers to identify/implement critical initiatives, PAT, and new technologies that improve productivity and quality.
Uses scientific knowledge to make decisions on projects. Analyzes data and results and makes recommendations that impact both the science and the business.
Preferred Skills:
Experience with cell therapy manufacturing equipment and processes.
Knowledge of relevant industry guidelines and standards, such as ISCT, FDA, and EMA regulations for cell therapy products.
Project management experience and certification (e.g., PMP) would be advantageous.
Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
Develops creative solutions to complex problems applying business and industry knowledge.
When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.
Why AstraZeneca?
At AstraZeneca, we are driven by our commitment to deliver accelerated growth and to make people's lives better. Our Operations team is at the forefront of this mission, delivering more medicines to patients quicker and more affordably. We are disciplined thinkers and doers who thrive in our often intense and ambiguous environment. We are part of an inclusive and giving community, supporting each other on our journeys. We are intellectually stimulated by constant learning and there's potential for multiple, global careers for those who embrace the diverse opportunities. If you have the passion and the drive to accelerate growth and make people's lives better, then AstraZeneca is the place for you.
Ready to make a positive impact? Apply now to join our team!
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.
