Associate Principal Scientist - Bioassay & Critical Reagents
At AstraZeneca, we work together across global boundaries to make an impact and find answers to challenges. We do this with the upmost integrity even in the most difficult situations because we are committed to doing the right thing.
Our Frederick facility creates life-changing medicines for people around the world. We make a direct contribution to treating people with cancer, respiratory and autoimmune conditions across the globe. From catered site festivities to competitive events, community outreach activities, environmental and wellness showcases and team-building events, we take time to recognize our achievements. The Frederick Manufacturing Center is dedicated to building a culture of inclusion and collaboration. We host yearly Inclusion and Diversity conferences and have an employee resource group dedicated to promoting diversity and inclusion and improving employees' professional development through interactive and engaging events and initiatives. We are also an award-winning employer and has been recognized as a 'Top 50' Business in Frederick, and Frederick County's 'Best Place to Work' distinction in 2015 and 2019.
The Associate Principal Scientist plays a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients' lives. This position is responsible for supporting commercial bioassay activities within Global Technical Operations analytical method transfer, validation, training and trouble shooting. This is a lab-based position.
What you'll do:
You will be responsible for conducting or participating in technically fast paced projects within your specific area or field, including the following:
Essential for the role:
- Responsible for performing and troubleshooting cell based assays, while applying these methods to a broad range of late stage, phase 3 clinical and commercial bioassays in a GMP environment.
- Responsible for maintaining technical expertise on several analytical areas and instrumentation.
- Maintaining up-to-date familiarity with applicable regulations and regulatory guidance associated with analytical method design/transfer/validation requirements.
- Manage authoring, review and approval of all technical documents, qualification protocols, SOPs, reports, and Certificates of Analysis as well as the coordination of all lab work necessary to complete qualifications on time.
- Author/Review sections of regulatory submissions related to bioassay methods and validation.
- In alignment with department/company strategic initiatives, influence and implement technology upgrade and continuous process improvements to analytical testing.
- Establish harmonized processes and best practice on various activities related to global critical reagents.
- Serve as a mentor and coach for other Scientists within the team.
- Degree in an engineering or scientific discipline with biopharmaceutical Manufacturing Science or related industry experience.
- B.S with 12+ years of experience
- M.S. with 8+ years of experience
- PhD with 4+ years of experience
- Extensive experience with validation and troubleshooting cell-based potency methods and ELISA based methods to support commercialization of different products.
- Experience with generation and qualification of Working Cell Banks
- Experience working with molecular-based (PCR) assays.
- Experience working with stable cell line generation and BSL2 level biological agents.
- Proficiency in utilizing statistical software for design of experiments and dose-response curve analysis (PLA, JMP, DoE, SoftMax Pro, etc.).
- Ability to apply critical thinking to solve problems and work independently.
- Strong interpersonal and communication skills.
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're opening new ways to work, groundbreaking cutting edge methods and bringing unexpected teams together. Interested? Come and join our journey.Next Steps - Apply today!
To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience - it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity. If you know someone who would be a great fit, please share this posting with them.Find out more on Social Media:
About Operations https://www.youtube.com/watch?v=gak5Ham8oUw