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 Manufacturing Associate in Frederick, 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 Responsibilities
The Associate is responsible for supporting tech transfer initiatives (authoring of batch production records and related non-conformances) and implementing technical or efficiency projects within the function. In this role, the Associate is responsible for the following:
- MPR generation and revision
- On the floor support for execution of process changes
- Training on documents and process changes
- Document review and coordination of changes with production area
- Support specialists/supervisors as needed
- Support investigations
- Supporting projects as needed
- Point of contact for cross department request
- Reviewing source documents (QCTP, FFR, PD, etc) to ensure alignment with manufacturing capabilities
- Troubleshooting process and equipment failures
- Recipe review and testing
- Label generation and revisions
- Contributes to the development of new concepts, techniques, and standards
- Considerable knowledge of cGMP standards, and the current code of Federal Regulations (CFR)
- Considerable knowledge to perform trouble shooting and root cause analysis
- Complete acquaintance with and understanding of the general and detailed aspects of the job, and their practical applications to problems and situations ordinarily encountered
- Equipment knowledge to perform first line trouble shooting and root cause analysis
- B.S./B.A./M.S. engineering, biological sciences, physical sciences, or equivalent field of study.
Years of Experience
- 1-3 years work experience in pilot or commercial biologics manufacturing under cGMP with Bachelors. 0-2 years with Masters degree.
- Ability to apply common sense understanding to carry out detailed but uninvolved written or oral instructions.
- Develops solutions to complex problems requiring ingenuity and creativity/innovation.
- Ability to deal with problems involving a few concrete variables in standardized situations
- Ensures solutions are consistent with organization’s objectives
Freedom to Act
- Work is performed without appreciable direction and dependent on level, limited supervision and minimal instructions needed on routine work .
- Depending on level and experience, expresses latitude in determining objectives and approaches to assignment or may require some instructions given on new lines of work or special assignments
- Ensures that projects are completed on schedule following established procedures and schedules
- Errors in judgement or failure to achieve results would result in the expenditure of large amounts of company resources.
- Errors may be difficult to detect and would normally result in loss of material or equipment down-time.
- Contacts are frequent with individuals representing other departments, and/or representing outside organizations
- Contacts involve obtaining or providing information or data on matters of moderate importance to the function of the department or which may be of sensitive nature, requiring some explanation or interpretation
- Good communication skills, both verbal and written, and effective presentation skills are preferred
- Good organizational skills
- Basic first-line management skills for daily operation
- Situational Self Leadership
- Decision making skills
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.