Do you have a passion for science? Would you like to apply your expertise to impact a company that turns ideas into life-changing medicines? 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 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 host cutting-edge technology and lab spaces 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 boost productivity and 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. Here, you’ll find newly-designed, activity-based workspaces to suit various working styles while increasing collaboration between teams.

Summary of the Group:

The PEP function develops Drug Product (DP) clinical and commercial fill/finish processes, device/combination product assembly processes, and packaging for biopharmaceutical products in the AstraZeneca Biologics portfolio.

Main Duties & Responsibilities:

Pilot Laboratory Operation: Contribute to the operation of a fill-finish pilot laboratory with lab-scale capabilities, including vial filling and lyophilization. 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).

Process Characterization: Conduct experiments in development laboratories or manufacturing sites to characterize processes in support of clinical and commercial tech transfers. Establish design space of fill-finish unit operations and set the manufacturing control strategy. Support clinical and commercial filings through regulatory writing. Maintain cutting-edge technical knowledge through ongoing academic, regulatory, and vendor literature review, and communicate findings to the team.

Tech Transfer: Assist in the 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 and support investigations. Strong 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:

Degree in mechanical, chemical, or pharmaceutical engineering, chemistry, materials science, or a related field with 5+ years (BS) or 2+ years (MS) experience in the pharmaceutical industry.Suitable experience may include university laboratory research, pharmaceutical R&D internships or full-time positions, or similar.High degree of self-motivation and technical rigor.Strong communication and technical writing skills.Experience participating in cross-functional teams.Candidates with GMP processing experience in technical services, project management, QA, or validation are considered. Candidates from a device development or small molecule parenteral background are also considered.

Required Skills:

Biopharmaceutical drug product developmentTechnical Transfer activities in the biotech/pharmaceutical industryCombination product and cGMP regulationsKnowledge of fill-finish unit operations including formulation, mixing, filtration, fill, and lyophilizationBiopharmaceutical degradation pathways and mechanismsExperimental design, statistics, data analysisTechnical writing and documentationAbility to handle multiple ongoing work streams in an organized fashion

Desired Skills:

Experience in vaccine developmentExperience with authoring regulatory documents

Why AstraZeneca?

At AstraZeneca, when we see an opportunity for change, we seize it and make it happen, because any opportunity, no matter how small, can be the start of something big. Delivering life-changing medicines is about being ambitious - finding those moments and recognizing their potential. Join us on our journey of building a new kind of organization to reset expectations of what a biopharmaceutical company can be. This means we’re opening new ways to work, pioneering innovative methods, and bringing unexpected teams together. Interested? Come and join our journey.

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 follow all applicable laws and regulations on inclusivity in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

The annual base pay (or hourly rate of compensation) for this position ranges from $80,653.60 - 120,980.40 USD Annual. Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours. Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles). Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base pay (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.

Date Posted

12-Feb-2025

Closing Date

27-Feb-2025Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.