Director, Biopharm Bioanalytical Strategy Lead, Integrated Bioanalysis

1 month ago

United Kingdom AstraZeneca GmbH Full time

Director Integrated Bioanalysis –Biopharm Bioanalytical Strategy Lead

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

Are you ready to work at the cutting-edge, where scientific innovations and an entrepreneurial spirit are the norm? We are looking for dynamic thought leaders with 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.

What we do

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

Why we love it.

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 what we do across our industry leading portfolio which drive exciting opportunities and varied work. We are on an exciting journey to pioneer the future of healthcare

The role

As part of the Integrated Bioanalysis (IBA) Global Team, you will be responsible for leading the design and implementation of robust bioanalytical strategies, including but not limited to, endpoints such as PK/CK, immunogenicity and biomarkers when required to support the AstraZeneca pipeline. You will be intimately involved in ensuring lab-based activities are aligned with context of use. You will work in a matrix manger with to manage aspects such as experimental design and tech transfer and will need to foster s close interaction with other scientific and technical staff in the lab. The ideal candidate will have a strong track record in regulated bioanalysis supporting therapeutic modalities across Biopharm. Working with a dynamic team in a matrixed environment you will need to manage stakeholder expectations, input to project strategy and delivery while being the main interface with experienced and highly skilled bioanalytical scientist colleagues or our partnered labs. 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.

What you will do

You will be located at one of our research hubs ideally on the east coast of the US, (Gaithersburg, MD or Boston , MA) or Cambridge, UK, where you will work alongside TA leads and stakeholders. In this role you will interact closely with scientist in and outside the lab based and you will be required to aid in experimental design and data interpretation of key experiments. This is a highly visible role, and you will be required to leverage your scientific knowledge and expertise while working with a range of stakeholder and cross functional groups. You will need to use your experience and proven track record designing, developing and delivering robust bioanalytical strategies with a specific focus on scientific oversight and delivery for our Biopharm portfolio. You will also work with regulatory agencies and Health Authorities across a range of countries and geographies to mitigate risk, submit regulatory documents and respond to Health Authority questions. As a Subject Matter Expert, you will be responsible for enhancing the IBA reputation for scientific excellence by presenting at internal and external meetings, and publishing manuscripts.

The successful candidate will work closely with AstraZeneca laboratory groups within IBA and our vendor partners to ensure appropriate bioanalytical and platform strategies, scientific oversight and delivery of our cell and gene therapy pipeline while fostering an environment of scientific knowledge exchange. They will also interact with stakeholders and cross functional project teams.

Education/Experience required:

  • PhD preferred n immunology, molecular biology or related studies with significant relevant experience. Will consider MSc degree + 5-7 yrs of experience or BSc degree with 10+ yrs of experience

Essential for the role:

  • Proven experience as a Subject matter Expert in regulated bioanalysis across a range of modalities PK/CK, PD and immunogenicity assessments (humoral and cellular)
  • Experienced as a bioanalytical lead in diverse project teams, defining, leading and implementing robust bioanalytical strategy to advance the portfolio.
  • Worked collaboratively with stakeholders, providing solutions to challenges and mitigating risk.
  • Skilled scientist able to discern the advantages and fir fall of a range of analytical techniques such as molecular assays (ddPCR, qPCR, RT-qPCR), flow cytometry, ELISpot, viral assays, cytokine assays, ligand binding assays and Mass Spectrometry
  • In depth knowledge of concepts such of context of use of fit for purpose assay validation in bioanalysis
  • Overseen assay transfer, scientific quality and study conduct at CRO partners.
  • Deep understanding of global regulatory expectations and guidance
  • Contributed to regulatory submission documentation such as INDs, CTAs, IBs, ISI and/or NDAs/BLAs and experience in regulatory authority responses across multiple geographies.
  • Interpretation of integrated and complicated datasets
  • Ability to handle multiple projects and / or tasks concurrently in a fast-paced environment.
  • Ability to develop, coach and mentor.
  • Background in pharmaceutical clinical trial research
  • Proven publication and presentation record
  • Exceptional verbal and written communication skills

Desirable for the role:

  • Matrix or line management experience
  • Experienced in regulated bioanalysis for other drug modalities
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