Associate Director- Molecular Specialist

2 weeks ago

Gaithersburg, United States AstraZeneca Full time

**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’re 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 for 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’re on an exciting journey to pioneer the future of healthcare

**The role**

As part of the Cell and Gene Therapy Group in Integrated Bioanalysis (iBA) Global Team, you will demonstrate scientific bioanalytical leadership across a broad array of cell and gene therapy modalities including CAR-T therapies, Gene therapies and Therapeutic Genome Editing in a lab-based and project facing role.

You will use your experience and know how across a range of molecular techniques to help evolve strategies to assess cellular kinetics (CK) & biodistribution, working as part of a team responsible for the design and implementation of robust bioanalytical strategies to support the AstraZeneca pipeline. You will also drive the advancement of scientific knowledge across our Biopharma and Oncology portfolios by contributing to project teams across modality. 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 (CPSS) 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’ll do**

You will be located at our research hub in Gaithersburg, where you will provide scientific oversight to deliver on bioanalytical strategies with a specific focus on our cell and gene therapy portfolio. You will be responsible for development of the teams’ molecular capabilities, inputting into strategy, science, and tactical operations. In this role you will be highly visible; working across iBA and CPSS functions, alongside TA leads and stakeholders, and able to use scientific knowledge and expertise while working with a range of cross functional groups. You will need to use your experience and proven track record designing, developing and delivering robust bioanalytical strategies and associated bioanalytical methods. You will also work with colleagues involved in interactions 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.

**Education/Experience required**:

- PhD in immunology, molecular biology or related studies with significant relevant experience

**Desirable for the role**:

- A bioanalytical expert with a broad array of technical and scientific experience using a multitude of molecular technologies
- Proven experience as a scientific expert across a range of cell and gene therapy modalities including CAR-T therapies, Gene therapies and Therapeutic Genome Editing
- 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 pitfalls of a range of analytical including molecular and cellular techniques
- In depth knowledge of concepts such of context of use of fit for purpose assay validation/ qualification in bioanalysis
- 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

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