Director, Process Engineering & Packaging
At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you’re our kind of person.
About AstraZeneca in Gaithersburg, MD:
Our Gaithersburg, Maryland facility builds life-changing medicines for people around the world. This campus employs more than 3,500 experts in our field and is only a short drive from Washington, DC. This modern and vibrant scientific campus is the home of R&D and Oncology in the US. Here, we play host to some of the most innovative technology and lab spaces, all designed to encourage collaboration and cross-functional science. We believe employees benefit from being challenged and encouraged at work. We are dedicated to creating a culture of inclusion and collaboration.
The Gaithersburg site offers a variety of amenities to help boost efficiency and help keep our employees happy and healthy. This includes a fitness center, employee healthcare clinic, electric vehicle charging stations, dry cleaning, full-service cafeteria and copy center. This is where you’ll find newly-designed, activity-based work spaces to suit a variety of working styles while growing collaboration between teams.
The incumbent will fulfill a strategic 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. Specific accountabilities include: (1) leadership of process development for late-stage clinical products; (2) development of robust drug product processes for commercial production (in collaboration with Operations); (3) technology transfer to both internal and outsourced commercial manufacturing; (4) development and maturation of an advanced scale-down fill/finish development lab for technical support of clinical and commercial production.
The incumbent will help lead all aspects of the process development and technology transfer of a diverse group biopharmaceutical dosage forms, including liquid and lyophilized formulations, various primary container formats, with specific focus on late stage biologics pipeline. The incumbent must maintain a strong technical culture and be able to establish strong working relationships at internal and external interfaces. This position 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, 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
Provide technical and strategic leadership and management for the development of drug product processes for late stage programs. Scope includes accountability for, development and technical support of clinical and commercial Drug Product processes, technology transfer to internal and outsourced manufacturing and ad-hoc technical support for commercial production as needed
Apply their scientific and engineering knowledge and tools to issues and problems arising during development and execution of processes
Lead and manage Drug Product and/or CMC functional teams, including resource management, prioritization, critical assessment of technical work, support of project teams, and developing relationships with functional partners
Lead and run business process improvement and standardization initiatives
Manage and mentor staff
Provide leadership and create strategies to evolve the capabilities of the organization in alignment with AstraZeneca strategies, growing health authority expectations, and changing external drug product competitive landscape
Drive a culture of innovation and high-quality science and engineering
Lead technology development and operational improvement initiatives to improve project execution efficiency
Influence regulatory strategies and standardize submissions and provide guidance and reviews of regulatory information packages and filings/submissions
Broadly influence and educate senior leaders and the larger AstraZeneca functional areas and product teams on drug product development
Create solid partnerships with key interfaces and represent BPD on senior leadership teams, committees and councils
Champion sustainability initiatives within PEP to meet AstraZeneca’s carbon-negative ambition
B.S., M.S. or Ph.D. in Chemical Engineering or other relevant Engineering field, Pharmaceutical Sciences, or related field with 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.
BS: 15+ years
MS: 13+ years
PhD: 10+ years
Candidate must be recognized leader in drug/combination product development
Must possess in depth knowledge developing and driving strategies for drug product process development
Experience in CMC aspects of biopharmaceutical development
Experience with regulatory agency interactions and author/review of regulatory filings/submissions
Demonstrated ability to lead / influence cross-functionally and at a senior level within the organization, including direct experience influencing and working with senior leaders
Demonstrated ability to effectively lead and develop professional staff, and 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
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.
AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.