Associate Scientist, Biosafety and Bioassay Development

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:

Summary of the group:

The Bioassay, Biosafety and Impurities Group develops and delivers fit-for-purpose, robust, and technologically advanced biological assays to progress pipeline products from research to commercial. We support end-to-end biosafety characterization of AstraZeneca pipeline assets including cell and gene therapy, monoclonal antibodies (mAbs), Antibody Drug Conjugates (ADCs), oncolytic viruses and viral vaccines.

Main Duties & Responsibilities:

The major responsibilities are:

• Develop, optimize and perform routine species specific virus detection assays to detect adventitious viruses in raw materials, in-process samples and other biological samples during various stages of manufacturing.
• Perform test methods for the detection adventitious agents (Bacteria, Fungai and viruses) and report following the sample management process. If required generate risk-based testing approach for cell and gene therapy programs

• Develop and optimize species specific virus detection assays to detect adventitious viruses in raw materials, Active Pharmaceutical Ingredient (API) and other biological samples during various stages of manufacturing.
• Develop test methods for the detection adventitious agents and to generate risk-based testing approach for cell and gene therapy programs.
• Develop test method for karyotyping to examine chromosomes in the cells
• Collaborate with cross-functional teams (upstream, downstream, and formulation) in a multidisciplinary environment and be responsible for multiple projects.
• Generate and manage required microbial and viral biosafety testing related documents example; Standard Operating Procedures (SOP’s), White Papers and Risk Assessments within the BioPharmaceutical Development (BPD) group.
• Independently develop and manage strategy for validation and product specific qualification (PSQ) for both microbial and viral biosafety testing.
• Responsible for developing, reviewing study plans, reports and coordinating studies at outside testing laboratories for all biosafety testing.

Education & Experience Requirements:

• BS/MS in Molecular Biology, Cell Biology, Virology, Immunology or Biological Sciences.
• Bachelor's degree with 0+ years or Master's degree with 0+ years of relevant industry experience.
• Relevant industry experience is essential for this role.

Required Skills:

• Hands-on experience with molecular techniques: DNA & RNA extraction, primer designing, PCR, qPCR, digital PCR and Gene arrays.
• Expertise in library construction, sequencing (Next Generation, High Throughput Sequencing technologies) and bioinformatics analysis for product identification and detection.
• Hands-on experience in cytogenetics, gene expression studies for cell and gene therapy products, RNA, DNA and viral vaccines.
• Work experience with viral vector for titer determination by infectivity assays (focus forming unit assay, TCID50, plaque assay) and gene copy number (GCN) determination by qPCR or digital PCR assays.  
• Experience in functional characterization and potency assays development for monoclonal antibodies, oncolytic viruses and viral vectors.  
• In depth knowledge and experience with bioassay development, optimization, technology transfer, assay qualification and validation following ICH guidelines.
• Knowledge on biosafety testing such as; sterility, bioburden, mycoplasma and adventitious agents detection testing for microbial contamination and identification.
• Demonstrated ability to work effectively and collaboratively with other scientists on cross-functional projects teams.
• Excellent oral presentation and communication skills, both written and verbal.

Desired Skills:

• Strong ability to work both independently and in a team environment
• Strong ability to multi-task and prioritize workload
• Strong scientific skills including sound experimental design (DOEs), data processing,  interpretation and presentation
• Proficient in MS Word, Excel, Power Point and other applications
• Knowledge of cGMP, FDA and ICH guidelines for biologics manufacturing
• Experience managing tech transfers to Contract Research Organization (CROs)/ Outside Testing Labs (OTLs)
• Experience working on Early, Mid to Late stage Cell & Gene Therapy. Viral, mAbs products is a plus
• Familiarity with regulatory guidance and submissions for vaccines and cell and gene therapies

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?

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

The annual base salary for this position ranges from $ 66,766.40 - 100,149.60

However, 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) or to receive a retirement contribution (hourly 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 salary (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.