Senior Director Process Engineering & Packaging

AstraZeneca - Gaithersburg, MD (30+ days ago)4.1


If you’re inspired by the possibilities of science to change lives and you thrive when making brave decisions – join us.

MedImmune is the worldwide biologics research and development arm of AstraZeneca. Here, you’ll have the opportunity to make a difference in people’s lives every day. As one of the world’s premier biotechnology companies, our mission is centered on delivering life-changing products that advance world health, and help fight and cure disease.

We’re constantly pushing the boundaries of science to deliver life-changing medicines to patients, with a passion for discovery and a pipeline to show for it. We’re pioneering innovative research and exploring novel pathways across key therapeutic areas including oncology, respiratory, inflammation and autoimmunity, cardiovascular and metabolic disease, and infection and vaccines. And we’re industry-leading in immunology, protein engineering and translational science. We offer a unique and strong collaborative network as part of the AstraZeneca family, as together we explore synergies between small and large molecules.

MedImmune has a dynamic environment that fosters collaboration and innovation. We attract top minds, and we nurture and build top talent.

As a Director or Senior Director, Process Engineering & Packaging in Gaithersburg, MD or Cambridge, UK, you’ll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients’ lives.

Director / Senior Director Process Engineering & Packaging

Position Summary

Based in either Gaithersburg, MD or Cambridge, UK, the incumbent will lead the Process Engineering and Packaging organization. This function develops early and late stage clinical fill/finish processes, combination product assembly processes, and packaging for biopharmaceutical products in the MedImmune portfolio. Accountabilities include leadership of the organization responsible for process development and packaging for clinical products, development of robust drug product and device assembly processes for commercial production (in collaboration with Operations), technology transfer to both internal and outsourced commercial manufacturing, managing an advanced scale-down fill/finish development lab and technical support of clinical and commercial production. The incumbent will oversee the process development of a diverse group of 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 leader must maintain a strong technical culture and be able to establish strong working relationships at internal and external interfaces. This position requires effective collaborative interactions with MedImmune / 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 and device assembly 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
Lead and manage a department, including resource management, prioritization, critical assessment of technical work, support of project teams, and developing relationships with functional partners
Manage and mentor leaders and develop people
Provide leadership and create strategies to evolve the capabilities of the organization in alignment with MedImmune strategies, growing health authority expectations, and changing external drug product competitive landscape
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 MedImmune 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
Ensure that MedImmune is a leader in the industry by being active in the external biologics manufacturing development and devices community through, for example, presenting at major conferences, participation in industry consortiums, etc.
Education
B.S., M.S. or Ph.D. in Chemical Engineering or other relevant Engineering field, Pharmaceutics, or related field with 13+ 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.

Requirements

Candidate must be an established industry leader in drug product manufacturing process development
Must have 10+ years managerial experience
Must possess in depth knowledge developing and executing strategies for drug product manufacturing process development
Must have strong knowledge of design for manufacturing
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 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
Experience in leadership of and/or membership of enterprise level committees, initiatives or task forces
Position is based in Gaithersburg, MD or Cambridge, UK. Staff will be located in both Gaithersburg, MD and Cambridge, UK.
Next Steps – Apply today!

To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience – it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity. If you know someone who would be a great fit, please share this posting with them.

AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.