Job Abstract

Bold Disruptors. Push the boundaries of science. Fearlessly break new ground.

Are you ready to work on ground breaking science, where scientific innovations and an entrepreneurial spirit are the norm? We’re looking for leaders with vision and curious minds, who are comfortable taking smart risks and constantly challenging the boundaries of science all the while learning and developing core skills and experiences.

We are a global, science-led BioPharmaceutical business and our innovative medicines are used by millions of patients worldwide.

The future is bright at AstraZeneca as we bring ground breaking therapies to complex disease to patients with critical needs. Scientific innovations are at the core of our values. We strive to achieve industry leader portfolios which drive exciting opportunities and varied work. We’re on an exciting journey to pioneer the future of healthcare!

As part of the Integrated Bioanalysis (iBA) Global Team, you will be responsible for developing cell based assays with specific focus on immunogenicity assays to support a range of biotherapeutics modalities, including but not limited to cell and gene therapies, ADCs, multi domain specifics. The ideal candidate will have extensive technical expertise in assay development, validation of cell-based assays as well as bioanalysis. Your areas of responsibility in assay development, optimization, validation of high complexity cell-based assays using state-of-art instrumentation support pre-clinical and clinical studies. You will also contribute to tech-transfer to established CRO partners and be called upon to review data to ensure assays meet regulatory expectations or are fit for purpose including troubleshooting and data analysis. You will be encouraged to provide scientific leadership to junior staff and to develop strong collaborations intra and inter-departments. You will contribute to the development of advanced bioanalytical techniques across all aspect of AZ portfolio within Oncology and Biopharm. Working with a dynamic team in a matrixed environment you will need to manage partner expectations, input to project strategy and delivery while being the main collaborator with experienced and highly skilled bioanalytical scientist colleagues. You will have the opportunity to have an immediate and lasting impact to our diverse pipeline.

The iBA group within Clinical Pharmacology and Safety Sciences provides broad discovery, preclinical, and clinical support including life cycle management across all therapeutic areas enabling pipeline delivery, decision making, innovation and advancement to improve the lives of patients through life-changing medicines.

Located at our research hub in Gaithersburg, MD, you will work alongside a team of experienced bioanalytical scientists supporting needs across our portfolio. Additionally, you will work closely with bioanalytical strategy leads to ensure assays meet regulatory expectations or the intended context of use. You will be responsible for regulated bioanalysis review, approvals of bioanalytical data and reports, and contribution to regulatory submission(s). Your expertise may be required to interpret data and provide scientific insight. As a Subject Matter Expert, you will be responsible for enhancing the iBA reputation for scientific excellence by speaking publicly at internal and external meetings, and publishing manuscripts.

The successful candidate works closely with AstraZeneca laboratory groups within iBA and our vendor partners when needed to ensure appropriate bioanalytical methods are transferred to our partners while fostering an environment of scientific knowledge exchange. This role also interacts with stakeholders and cross functional project teams.

• PhD in immunology, molecular biology or related fields with significant relevant experience

• Proven experience as a Subject matter Expert in cellular assay techniques including the development and validation of robust, innovative immunogenicity assays for supporting preclinical and clinical studies
• Design, develop, validate, and troubleshoot assays to ensure they are in line with regulatory expectations or fit for purpose
• Provide bioanalysis in support of GxP or GxP like studies. Review and approve bioanalytical data and reports to ensure quality and integrity.
• Your skills will be applied to contextualize and interpret data for use in key project decisions
• Collaborate effectively to ensure productive interactions with all partner groups.
• Demonstrate strong accountability, organizational and interpersonal skills, and apply scientific and technical experience
• Proven laboratory experience with following SOPs, GxP regulations, GxP documentation and knowledge with regulatory guidance
• Present data/ strategy to scientists and management
• Ability to handle multiple projects and / or tasks concurrently in a fast-paced environment
• Ability to train and mentor junior staff
• Proven publication and presentation record
• Exceptional verbal and written communication skills

• Extensive immunology knowledge and experience
• Experience across a range of technology platforms for immunogenicity assessment including but not limited to LBA, cell based in vitro and in vivo assays, Elispot
• Experienced in regulated bioanalysis for a range of biotherapeutics modalities

So, what’s next?

Are you already imagining yourself joining us? Good, because we can’t wait to hear from you!

Advertising opens on October 6 2023, and we welcome with your application; CV and cover letter, no later than October 27 2023.

Our Company Values & Behaviours underpin everything we do so please take a moment to familiarize yourself with them. You may also want to check out our new R&D Video showing how we turn Science into Medicines.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Expectation of working in the office 3 days a week statement: When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working give us the platform we need to connect, work at pace and challenge perceptions. That’s why we work, on average, a minimum of three days per week from the office. But that doesn’t mean we’re not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

Date Posted

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