Gcp Team Lead Basel

vor 5 Monaten

Basel, Schweiz Novartis Vollzeit

390761BR

**GCP Team Lead Basel**:
Switzerland

**About the role**

5600 scientists working on over 300 discovery programs in 8 disease areas focusing on 90 new molecular entities makes BioMedical Research (BR), Novartis the premier place to develop your career as a pharmaceutical professional. If you are curious, scientifically minded, and want to positively impact society by speeding delivery of novel therapies to patients, then look no further, BR is the place to be.
Are you looking to build and grow your leadership opportunities? As a Director in the Translational Medicine Drug Disposition Bioanalytical group, you will have the opportunity to make a difference. If you have a collaborative nature, a commitment to teamwork across an organization and a relentless focus on improving patient care we want you to apply.
In the Director role, you will use your leadership skills, scientific acumen, strategic mindset, and regulated bioanalysis experience to lead a team of scientists in method development, validation and clinical sample analysis focusing on our novel modality biologics portfolio.
In setting the standard for operational excellence in a regulated clinical bioanalytical lab:
Your main responsibilities will include but are not limited to:

- As test site facility head, be responsible for overseeing the scientific and regulatory compliance for all developed ligand binding, PCR, and mass spectrometry assays for pharmacokinetic, pharmacodynamic and immunogenicity bioanalysis for all therapeutic modalities (proteins, mono, bi and tri-specific molecules, gene therapy, cell therapy, radioligand therapeutics and more).
- Reviewing the strategic, operational, and technological aspects of the team and proposing modifications and improvements with a focus on continuous quality improvement and innovation.
- Collaborating with other test site facility heads to ensure global harmonization and alignment.
- Providing consultation and technical support for preclinical and clinical immunogenicity strategy discussions within Global Bioanalysis, and data interpretation consistent with current industry and health authority guidelines.
- Contributing and reviewing relevant bioanalytical sections to regulatory and submission documents (e.g. IB, IND, CTD).
- Hire and lead a team of up to 40 (including lab heads and bench scientists) carrying out regulated bioanalytical sample analysis.

**Commitment to Diversity & Inclusion**:

- We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve._

**Role Requirements**
- M.S. or Ph.D. with significant and relevant (10+ years) GCP experience in a pharmaceutical, CRO or related industry.
- Hands-on experience with the development of ligand binding, mass spectrometry, cell-based and/or PCR assays with the proven ability to develop BA strategies across a variety of modalities using different technologies.
- Strong engagement, interpersonal communication skills and ability to work in a dynamic global matrix environment with frequently shifting priorities and timelines.
- A thorough understanding of industry landscape and Health Authority guidelines.
- Demonstrated success building, leading and developing a team of experienced scientists
- Experienced in writing and supporting others contributing to the bioanalytical sections of regulatory and submission documents.
- Demonstrated success moving a strategy from ideation to completion with advanced stakeholder management.

Why consider Novartis?

Flexibility: Novartis offers a flexible working environment for lab-based associates

Culture: Novartis is a curious, empowered, inspired, unbossed, collaborative environment

Growth and development: Associates are encouraged to take ownership of their growth and development with several cross-functional development (technical and leadership) options to explore

Total rewards: Novartis offers competitive: salaries, short and long-term incentives, health and retirement options, paid-time off, and many other benefits

Why Novartis?

766 million lives were touched by Novartis medicines in 2021, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives.

We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.

We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying

Imagine what you could do here at Novartis

**Division**

Biomedical Research

**Business Unit**

Translational Medicine

**Work Location**

Basel

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