Senior Scientist/Engineer, Process Engineer for Drug Products

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. 

Summary of the Group:

We are seeking a Scientist/Engineer to join the Process Engineering and Packaging team (PEP). 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. The Scientist/Engineer is a DP PEP lead in the CMC supporting projects and technologies, performing process development and tech transfer activities, and driving innovation and capability build. This position requires effective collaborative interactions with project team members, internal/external manufacturing sites and suppliers. Prior experience working with pharmaceutical and manufacturing process development are essential.  This individual must be able to work effectively in a matrix environment and be able to influence internally and externally.

Main Duties & Responsibilities:

Process Design and Development: Develop manufacturing processes, specify requirements of manufacturing equipment and support equipment design and build, perform process risk assessments such as FMEA, design characterization and engineering studies, develop control strategies, author protocols, technical reports and regulatory filing sections.  Provide technical rigor in design for manufacturing, experimental design, data analysis, and technical writing.  Develop pilot laboratory fill-finish process for 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.

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.

Tech Transfer: Lead late-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 manufacturing sites. Provide on-site support of fills, provide support to investigations. Ensure correct implementation of control strategies for the drug product into manufacturing records. Design and oversee validation activities for the drug product manufacturing processes. Manage timelines and activities internally, communicate goals and oversee successful delivery at the receiving site. Sound technical writing skills and interpersonal communication are required. Some travel is required (typically 1-5 trips per year) in the US and abroad. 

Leadership: Contribute strategic thinking to drug product development teams by providing knowledgeable advice on design for manufacturing, equipment vendor selection, manufacturing site selection / alternatives, project lead time and budget estimates. Advise functions and teams on new manufacturing technology selection and development. Develop risk-based characterization and validation strategies for manufacturing processes. Propose general working strategies and risk-based project strategies that meet requirements of design control, product quality, cGMP, as well as timeline and budget constraints. Research and design small scale comparability studies and template technology transfer processes.

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. Typical candidates will have a PhD 0-3 years or MS with at least 8 years, or BS plus 10 years of experience in the pharmaceutical industry as appropriate (biotechnology area preferred).

Required Skills:

The candidate should have capability, skill and/or knowledge in most of the following areas:

• Protein degradation pathways and mechanisms
• Biopharmaceutical drug product development
• Knowledge of formulation and fill-finish unit operations such as freeze-thaw, formulation, mixing, filtration, asceptic filling
• Strong knowledge of lyophilization technology and scale-up principles
• QbD, experimental design, statistics, data analysis and modeling
• Technical writing and documentation
• cGMP, aseptic processing, and related regulatory literature
• Ability to handle multiple ongoing work streams in an organized fashion
• Leadership and interpersonal communication skills

Experience: Suitable experience may include development of fill-finish and/or associated manufacturing processes.  Tech transfer experience or experience organizing and leading cross-functional teams is required. 

• A high degree of self-motivation, scientific strength and technical rigor is required.
• Experience working with biologics (mAbs, bispecifics, fusion proteins, enzymes, antibody-drug conjugates etc.) preferred.
• Strong communication and technical writing skills are essential. 
• Experience participating in cross-functional teams is valuable. 

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 entrepreneurial - finding those moments and recognising their potential. Join us on our journey of building a new kind of organisation to reset expectations of what a bio-pharmaceutical company can be. This means we’re opening new ways to work, pioneering cutting edge methods and bringing unexpected teams together. Interested? Come and join our journey.

So, what’s next!

Are you ready to bring new ideas and fresh thinking to the table? Brilliant! We have one seat available and we hope it’s yours.

Where can I find out more?

Check out our landing page for more information on our BPD group  https://careers.astrazeneca.com/bpd

Our Social Media, Follow AstraZeneca on LinkedIn https://www.linkedin.com/company/1603/

Follow AstraZeneca on Facebook https://www.facebook.com/astrazenecacareers/

Follow AstraZeneca on Instagram https://www.instagram.com/astrazeneca_careers/?hl=en

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.