Join our Cell Therapy as an Associate Director, MS&T Process Team. The selected candidate will primarily lead the cell therapy manufacturing process transfer from internal and external development organizations. In this position, you will also work with site technical operations and partners across MS&T manufacturing tech service, and facility engineers to drive the new product introduction, product yield improvement, and delivering successful drug substance batches and drug product batches manufactured at the site.
You will be accountable for developing, managing, and retaining bench strength and leadership across the analytical functions within MS&T through coaching, mentoring, and providing development opportunities to the team members. Success in these areas will require strong technical/scientific and management leadership skills, experience with the commercialization of biologics, analytical technologies, project management, and the ability to project cross-functional influence.
What you will do:
Support technology transfer and scale-up to commercial facilities.
Primary liaison between the Manufacturing and Development departments.
Direct the implementation of major manufacturing improvement projects.
Provide technical leadership to staff with focus on verbal and written communications, teamwork, and problem-solving. Prioritize resources, projects, and deliverables.
Experience with biopharmaceutical unit operations, equipment, and plant automation/sensors.
Knowledge of cGMPs and experience supporting validation efforts related to cell therapy programs.
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.
Develop, coach, and motivate staff using situational leadership tools.
Liaison with internal and external customers to identify/implement strategic 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.
Minimum Qualifications:
BS/MS/PhD in Cell or Molecular Biology, Immunology, Biological Sciences, Biotechnology, Biochemistry, or related field.
B.S. with a minimum of 8 years of experience, M.S. with a minimum of 5 years of experience, or Ph.D. with a minimum of 3 years of experience.
Data historian software (e.g. OSI /PI) and process data management (e.g. Discoverant)
Experience in process technology transfer within and between organizations, manufacturing support, and troubleshooting.
Experience in leading and managing a cell culture laboratory support function.
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 utilizing business and industry knowledge.
Technical/scientific knowledge of biopharmaceutical processes, at both process development and manufacturing scales of operation.
Knowledge of process scale-up and scale-down methodologies, including process characterization design of experiments.
Strong people management experience, including leading staff at the PhD-level.
Demonstrated teamwork, organizational, and leadership skills.
Proven ability to influence across functions and organizations.
Project management skills and technical writing skills.
Why AstraZeneca
At AstraZeneca, we are leading our Operations function at an exciting time of growth and evolution. We pioneer new approaches and processes across our sites, empowering our teams to foster a Lean mindset and sustainable practices. Every change we make is to deliver better outcomes for our patients. We are the champions of Lean, ensuring our teams understand and embody the benefits it can bring. Our manufacturing sites are environments of constant and rapid change. It's a place to expect the unexpected. There's rarely an obvious answer to the varied challenges we face, so it takes adaptability, flexibility, and patience to thrive here.
Ready to make your mark? Apply today and be part of a team that's redefining the science of medicine!
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.
