Work in a state-of-the-art laboratory that is focused on development of formulations and process for therapeutic proteins, antibody drug conjugates, monoclonal antibodies, T-Cell engagers, fusion proteins, and enzymes or other high potent (OEM 4 ) modalities (radio-conjugates). Additional activities will include formulation and fill finish process for therapeutic proteins, antibody drug conjugates, and other novel therapeutic modalities and provide support to research and discovery, clinical and... more details
Associate Scientist / Scientist (Early Formulation Sciences/DFDD – BPD)
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 are 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 will find newly designed, activity-based workspaces to suit a variety of working styles while increasing collaboration between teams.
Summary of the group:
This position is within Early-Stage Formulation Sciences responsible for designing and developing formulations and drug product presentations for Phase 1 through pivotal clinical trials.
Description: This position within Early-Stage Formulation Sciences is responsible for independently designing and developing formulation and drug product presentation for Phase 1 through pivotal clinical trials of novel biotherapeutic molecules, monoclonal antibodies, Antibody Drug Conjugates (ADCs) and other potential high potent modalities (radio-conjugates, OEB4+, etc). This position will also work collaboratively with Bioengineering for molecule selection prior to CDID. The candidate is expected to design, develop and execute experiments in the areas of pre-formulation, formulation screening and clinical/commercial product development, including fill-finish and lyophilization with minimal supervision. Perform biophysical characterization and/or analytical assays in support of protein solubility, stability, and elucidation of protein degradation mechanisms. Make detailed observations, analyze data, interpret results, maintain documentation, and prepare precise technical reports, summaries, and protocols with minimal supervision. Present findings at internal meetings and/or contribute to the preparation of manuscripts and patent applications. Function effectively as a member of one or more project teams.
Main Duties & Responsibilities:
• Work in a state-of-the-art laboratory that is focused on development of formulations and process for therapeutic proteins, antibody drug conjugates, monoclonal antibodies, T-Cell engagers, fusion proteins, and enzymes or other high potent (OEM4+) modalities (radio-conjugates). Additional activities will include formulation and fill finish process for therapeutic proteins, antibody drug conjugates, and other novel therapeutic modalities and provide support to research and discovery, clinical and manufacturing teams in moving drugs from candidate selection to commercialization.
• Work on protein biotherapeutic formulation, characterization, and stability testing.
• Work on Antibody Drug conjugates and other high potent molecules (OEB4+) formulation development, characterization, and stability testing. Lead various activities in evaluating and advancing the science in this field.
• Perform clinical compatibility and in-use support for clinical biotherapeutic administration of products
• Coordinates and supports lab equipment
• Develop analytical methods for biotherapeutics
• Perform biophysical characterization and/or analytical assay development in support of modality formulation, stability, and elucidation of degradation mechanisms. Make detailed observations, analyze data, interpret results, maintain documentation, and prepare precise technical reports, summaries, and protocols. Present scientific data to both internal audiences within the company and external scientific community.
• Functional representative on CMC teams and sub-teams
• Author CMC sections for regulatory filings and development reports.
Requirements for the Role:
• Science minded, highly motivated self-starter with drive to succeed, with good communication skills, strong interpersonal skills, demonstrated leadership qualities, and the ability to thrive in an interdisciplinary fast paced environment
• Ability to work/handle high potent (OEB4+) molecules and their components with proper care/skill
• Previous demonstration of creative problem solving and troubleshooting skills.
•Outstanding organizational and communication skills (written, verbal and presentation)
Desirables for the Role:
• Experience in current approaches for formulation development, biophysical characterization of proteins, protein stability, and analytical method development.
• Experience handling of High-potency molecules and working in isolator environments including lyophilization and fill/finish activities for compounds such as ADC’s
• Familiarity with fill finish process technology, aseptic drug product manufacturing process development, and cGMP knowledge is advantageous.
• Ability to work effectively as an individual contributor, and as a team member within team and matrix environments.
• Working knowledge of Drug Product dosage forms for biotherapeutics (vial, PFS, liq., lyo, etc)
• Biophysical Characterization techniques include Differential scanning calorimetry & Isothermal Titration calorimetry, Dynamic light scattering, High pressure Liquid Chromatography, UV/Vis spectroscopy, fluorescence spectroscopy, Circular Dichroism spectroscopy, particle characterization.
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 recognizing their potential. Join us on our journey of building a new kind of organization to reset expectations of what a bio-pharmaceutical company can be. This means we are opening new ways to work, pioneering cutting edge methods and bringing unexpected teams together. Interested? Come and join our journey.
So, what is next!
Are you ready to bring new ideas and fresh thinking to the table? Brilliant! We have one seat available, and we hope it is 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/
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Date Posted
14-Jun-2024
Closing Date
27-Jun-2024Our 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.
AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.
