Posted in Other 30+ days ago.
Location: Gaithersburg, Maryland
Do you have a passion for Science? Would you like to apply your expertise to impact a company that follows the science and turns ideas into life changing medicines? Then AstraZeneca might be the one for you!
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 creates 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 cutting-edge technology and lab spaces, all designed to inspire collaboration and cross-functional science. We believe employees benefit from being challenged and inspired at work. We are dedicated to crafting a culture of inclusion and collaboration.
The Gaithersburg site offers a variety of amenities to help boost productivity and help keep our employees happy and balanced. 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 increasing collaboration between teams.
Summary of the group
The position sits within the Process Engineering and Packaging (PEP) department within the Biologic Drug & Combination Product development parent organization (Dosage Form Design and Development, DFDD). The PEP group is staffed with engineers and scientists who develop manufacturing processes such as compounding, aseptic filling, device assembly, and packaging. PEP designs these processes and tech transfers them to manufacturing sites for clinical products up through licensure. Process development, characterization and validation are core responsibilities of the department.
Main Duties & Responsibilities
Primary responsibilities will include:
1) Process Design and Development: Design manufacturing processes suitable for clinical or commercial-scale production for biologic and novel therapeutic products. Evaluate current and new manufacturing technology to drive better quality and operational advantages. Develop pilot laboratory capabilities required for biologic and novel therapies. Characterize processes to establish acceptable processing conditions.
2) Tech Transfer and Validation: Support clinical-stage and commercial technical transfers to internal facilities and contract manufacturers. Work within an internal sending unit team including development functions (device, analytical, packaging, formulation, fill and assembly process SMEs), supply chain, project management and QA.
Education & Experience Requirements:
Educational requirements - a degree in mechanical, chemical, or pharmaceutical engineering, chemistry, materials science, or a related engineering or pharmaceutical science field.
BS or MS with at least 8 years of experience, or a PhD and 0 yrs. experience
Required Skills
The candidate should have at lease introductory-level knowledge in several of the following areas: