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. As a Manager of Research & Development in Gaithersburg, MD you'll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients' lives.
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.
Main Duties and ResponsibilitiesThe Manager, R&D will lead the Batch Record Creation and Tech Transfer team within the Manufacturing Sciences (MS) organization. The individual will represent MS and provide scientific strategic and tactical leadership in support of new and resupply manufacturing campaigns at the Gaithersburg Pilot Facilities. The position manages batch record creation and tech transfer timelines and requires close partnership with groups including but not limited to Bioprocess Engineering, Process development, Manufacturing Sciences, and Quality Assurance. The individual must possess the ability to multi-task and manage frequent changes in scope, timelines and priorities. Additional job expectations include intimate understanding of the manufacturing equipment and operating standards, critical review of data, critical thinking and creativity in solving problems/troubleshooting as well as data management and documentation. This position also includes direct reports and may have additional matrixed reporting responsibilities as needed.
The Manager, R&D will manage the day-to-day work related to batch record creation, revision, and approval for new and resupply manufacturing campaigns. This individual will also lead and facilitate the accountability of tech transfer timelines by close collaboration with all impacted functions. Other responsibilities include review and approve documents (MPR, SOP, SPR, MS, BOM) authored by junior staff as well as initiates and leads presentations/discussions of technical information concerning specific projects, schedules, etc. This individual must effectively communicates the status of the work to appropriate parties in order to keep them informed and involved. Serves as a technical liaison for the core production groups in Manufacturing Sciences. The Manager, R&D represents Manufacturing Sciences on CMC teams and is also responsible for supporting internal and external inspections/audits. Individual will Independently identify and resolve complex problems through good decision quality utilizing functional and technical skills and resources. Leads continuous improvement, process improvement initiatives within Manufacturing Sciences department as requested. Also responsible for performance management of direct reports including coaching, goal setting and career development.
Education: 10+ years experience in biotech/pharmaceutical industry with Bachelor's or Master's (8+ years experience) required, preferably in Engineering or Science fields. Relevant industry experience required in biologics and people management - preferably in process development, tech transfer, and/or cGMP manufacturing.
This individual must have a strong working knowledge of biologic processes to be considered. Individual must also be proficient in authoring and editing technical documents as this position requires advanced technical writing skills. Must have the ability to identify problems beyond their capability and recognizes the need to reach out for assistance when required. Other requirements for this position are the following: possesses strong organization and interpersonal skills, able to build effective teams and foster collaborative relationships, demonstrates strong presentation and facilitation skills, highly team/customer oriented, demonstrates creative thinking and a willingness to implement new approaches, and individual must have computer expertise in MS Office Suite.
Desirable RequirementsExperience in FMEA, QRM and Six Sigma preferred.
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.
A little about us:
MedImmune is the global biologics research and development arm of AstraZeneca