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Associate Principal Scientist, Bioanalytic Outsourcing

Location South San Francisco, California, United States Gaithersburg, Maryland, United States Job ID R-086575 Date posted 07/14/2020

Do you have expertise in, and passion for, Drug development, Clinical Pharmacology, and Integrated Bioanalysis?

We pride ourselves on making sure that each decision we make puts patient needs first! This mentality means that our people have permission to take a more unusual path. If they can think of a better, smarter way in which we can change lives through science, we want to hear it.

AstraZeneca is seeking an Associate Principal Scientist, Bioanalytical Outsourcing with a proven track record in the area of immunogenicity. The Associate Principal Scientist in the Outsourcing team is a member of the Integrated Bioanalysis team delivering the outsourcing and scientific oversight of AstraZeneca biologics projects subject to toxicology, PK/PD and clinical studies.

What you'll do:

As the Associate Principal Scientist of the Bioanalysis Outsourcing and GxP Lab global team within the Clinical Pharmacology and Quantitative Pharmacology Department, you will be responsible for GxP bioanalysis Outsourcing in support of the AstraZeneca pipeline. You will have an immediate and lasting impact to our pipeline supporting all therapeutic areas and implementing PK, PD and immunogenicity strategy, validation, and testing. You will report to the Head of Bioanalysis Outsourcing and UK GxP Lab. The successful candidate will work closely with all laboratory groups within Integrated Bioanalysis to ensure proper oversight, regulatory compliance, platform strategy, and external delivery of our biologics pipeline and may lead a team of outsourcing oversight scientists.


The Clinical Pharmacology and Quantitative Pharmacology (CPQP) provides broad discovery, preclinical, and clinical support, enabling pipeline delivery, decision making, and advancement.


Responsibilities:

  • External transfer, and oversight of the development, qualification/validation, and implementation of immunoassays/cell-based assays, molecular biology assays, and target engagement assays on multiple platforms for determination of drug in biological matrices, assessment of drug immunogenicity, and measurement of biomarkers at our external vendors in a GLP/GCP environment.

  • Will provide internal support for the preparation of regulatory documents for the molecules and studies which he/she leads all aspects of.


Education/Experience required:

  • PhD preferred; Masters's degree in a relative scientific discipline, with >3 years experience.

  • Bachelor's degree, in a relative scientific discipline with minimum 5-7 years experience


Essential Skills

  • Demonstrated experience in multiple technology platforms, including ELISA, MSD, fluorescence/luminescent plate readers, Envision, AlphaLISA, Quanterix, Gyrolab, LC/MS, and Luminex is preferred.

  • Strong background in the development, validation and implementation of immunochemical and cell-based assays to regulatory standards for a variety of biotherapeutic molecules.

  • Excellent track record in PK, biomarker and especially immunogenicity testing in clinical trial settings, with proven experience of external vendor and/or sponsor oversight.

  • Knowledgeable and experienced in the requirements for the Integrated Summary of Immunogenicity and Risk Management Plans.

  • Laboratory experience with GLP regulations, GxP documentation and regulatory guidance.

  • Detail-oriented, good documentation practices, technical writing and verbal communication skills.

  • Ability to handle multiple projects and/or tasks in a fast-paced environment.

  • Familiarity with spreadsheets, word processing, and graphical computer programs (e.g. Excel, Word, GraphPad Prism, etc.).

  • Background in Pharmaceutical and Clinical Trial Research.


Desired skills:

  • Familiarity with Automation platforms.

  • Experience in the bioanalysis of biotherapeutics on LC-MS platforms.

  • Demonstrated experience to oversee and interpret analyses using various platforms from multiple lab-based groups in addition to own immediate organization.

  • Experience with IND and/or BLA submissions.

  • Supported late-stage clinical programs.

  • Experience leading individual contributors.


Position may be in either Gaithersburg, MD or South San Francisco, CA.


Gaithersburg, MD Campus

The AstraZeneca Gaithersburg campus employs more than 3,500 specialists in our field and is only a short drive from Washington, DC. This green, sustainable, modern, vibrant scientific campus is where we host some of the most cutting-edge technology and lab spaces. Newly designed, state of the art research spaces and open seating floor plans are just a couple of ways we work cross-functionally and collaboratively.


South San Francisco, CA Campus

South San Francisco is a single world-class facility in the Cove at Oyster Point, in the heart of the area’s vibrant biotechnology and technology community. It’s our newest site that’s been designed to enable side-by-side talent to make the impossible, possible at the center of the biotechnology and high-tech industry.


Benefits:

AstraZeneca is a leading company in the healthcare industry, with a mission to enrich the lives of others. It’s our business to support healthy living, not only for our patients, but also for our employees. Our benefits program is flexible enough to meet employees’ varying needs, offers valuable choices, and is highly competitive.


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’re opening new ways to work, pioneering cutting edge methods, and bringing unexpected teams together. Come and join our journey.

So what's next?

We welcome your application, no later than 14th August 2020.

​If you’re curious to know more then please contact Jo Goodman at jo.goodman@astrazeneca.com

Where can you 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

#GxP #bioanalysis #outsourcing



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 authorisation and employment eligibility verification requirements.

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