The incumbent will fulfill a senior technical leadership role within the Process Engineering and Packaging (PEP) organization. The PEP function develops clinical and commercial fill/finish processes, combination product assembly processes, and packaging for biopharmaceutical products in the AstraZeneca portfolio. In collaboration with other functions, the incumbent will lead the PEP organization to harmonize and standardize the approach in process design and process qualification of parenteral drug products and combination products.
Specific accountabilities for the position include: (1) expert knowledge in internal and external manufacturing sites including process capability, facilities, manufacturing lines and equipment. (2) technical leadership of process development and packaging for clinical products; (3) development of robust drug product and device assembly processes for commercial production (in collaboration with Operations); (4) support technology transfer to both internal and outsourced commercial manufacturing.
The incumbent will support the process development of a diverse group biopharmaceutical dosage forms, including liquid and lyophilized formulations, various primary container formats, novel drug delivery formulations (e.g. nanoparticles, high concentration formulations, etc.), drug delivery devices and packaging. The incumbent must maintain a strong technical culture and be able to establish strong working relationships at internal and external interfaces. These positions require effective collaborative interactions with AstraZeneca leaders, particularly with the Global Biological Operations (Commercial Operations) organization and internal/external manufacturing sites within the manufacturing network. Experience working with functions such as late stage formulation development, device development, clinical operations, new product introduction, aseptic fill/finish operation, supply chain, quality and regulatory are also essential. This individual must be able to effectively lead in a matrix environment and be able to influence broadly internally and externally.
Major Duties and Responsibilities
Lead the PEP organization to harmonize and standardize the approach in process design and process qualification of parenteral drug products.
Provide technical leadership for the development of drug product, device assembly, and packing/labeling processes. Scope includes accountability for design for manufacturing, development and technical support of clinical processes, clinical packaging and support of commercial packaging, technology transfer to Global Biological Operations, and ad-hoc technical support for commercial production as needed.
Apply his/her scientific and engineering knowledge and tools to issues and problems arising during development and execution of processes
Manage and mentor leaders and develop people
Drive a culture of innovation and high-quality science and engineering
Influence regulatory strategies and provide guidance and reviews of regulatory information packages and filings/submissions
Challenge the status quo, yet build strong relationships with other leaders and functional partners
Broadly influence and educate senior leaders and the larger functional areas and product teams on drug product development
Create solid partnerships with key interfaces
B.S., M.S. or Ph.D. in Chemical Engineering or other relevant Engineering field, Pharmaceutical Sciences, or related field.
Bachelor's degree and 15+ years or Master's degree and 13+ years or Ph.D. and 7+ years of related experience in the biopharmaceutical industry.
Strong technical and scientific skills with proven experience in development of drug product manufacturing processes for biologics in primary containers and devices.
Candidate must be an established industry expert in drug product process development
Must possess in depth knowledge developing and executing strategies for drug product process development
Must have strong knowledge of design for manufacturing
Must have strong expertise in equipment design and qualification per GMP, including filling lines, lyophilizers, and device assembly secondary packaging lines
Must have strong project management expertise with demonstrated track record of project delivery
Must have strong knowledge of six sigma principles and tools
Experience in CMC aspects of biopharmaceutical development
Experience with regulatory agency interactions
Demonstrated ability to lead / influence cross-functionally and direct experience influencing and working with senior leaders
Demonstrated ability to work in a collaborative team environment across multiple technical functions
Must have a strong, broad understanding of industry scientific and technical advancements in drug product manufacturing process development
Experience in leadership of and/or membership of enterprise level committees, initiatives or task forces