Senior Engineer - Process Engineer & Packaging
AstraZeneca

Gaithersburg, Maryland

Posted in Pharmaceuticals


This job has expired.

Job Info


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 creating 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 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 increasing collaboration between teams.

Main Duties & Responsibilities:
1) Pilot Laboratory Operation: Contribute to the operation of a fill-finish pilot laboratory with lab scale capabilities including vial filling and lyophilization. The candidate will work on cross-functional teams to ensure equipment/process capability for process development studies on multiple pipeline projects. Perform risk assessments, design experimental protocols and write reports. Provide technical rigor in experimental design and data analysis across projects. Test, analyze and interpret a range of protein characterization assays (e.g. HPLC, UPLC, HIAC, MFI, cIEF etc).

2) Process Characterization: Conduct experiments in development laboratories or manufacturing sites to characterize processes in support of clinical and commercial tech transfers. These studies will be conducted to establish design space of fill-finish unit operations and set the manufacturing control strategy. Regulatory writing responsibilities include supporting clinical and commercial filings. Carry out ongoing academic, regulatory and vendor literature review, maintain cutting edge technical knowledge, and communicate findings to team.
3) Tech Transfer: Assist clinical-stage and commercial technical transfer of fill-finish processes to CMOs and internal manufacturing facilities for biopharmaceutical drug products. Support engineering and clinical fills at GMP fill-finish sites. Provide on-site support of fills, provide support to investigations. Sound technical writing skills and interpersonal communication are required. Some travel is required (typically 0-5 trips per year) in the US and abroad.

Education & Experience Requirements:

Educational requirements include a degree in mechanical, chemical, or pharmaceutical engineering, chemistry, materials science, or a related engineering or pharmaceutical science field with 0+ years (PhD) or 8+ years (MS) or 10+ years (BS) experience in the pharmaceutical industry as appropriate (biotechnology area preferred

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.


This job has expired.

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