Bioanalytical Outsourcing Scientist

hace 2 semanas

Barcelona, España Bayer A tiempo completo

**At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where ,Health for all, Hunger for none’ is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining ‘impossible’. There are so many reasons to join us. If you’re hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there’s only one choice.**

** Bioanalytical Outsourcing Scientist**

**Position purpose**:
Being responsible for the placement, monitoring and scientific review of bioanalytical studies and method development/ validation at Contract Research Organizations (CROs) as well as the assurance of the quality with respect to requirements by the regulatory agencies. Preparation of documents for INDs and NDAs as well as preparing responses to regulator agencies.

** Key tasks**:

- Selection of external providers for bioanalysis
- Proper planning with regard to timelines for all small molecule (SMOL) bioanalytical studies to be outsourced

- Continuously monitoring the performance of the CRO by in depth review of critical tasks; Make sure to provide quality data and reports on time
- Establishment of bioanalytical methodology at CRO including method transfer/ development/ (cross)-validation in support of the Bayer bioanalytical department
- Monitoring of CRO’s operations in conjunction with the Bayer Quality Assurance (QA) group
- Regular communication with CROs and face-2-face visits (if the pandemic situation allows)
- Close cooperation with QA, regulatory, biosample management
- Responsible for gathering and yearly review of key performance indicators (KPIs)
- Alignment with Toxicology outsourcing group for external toxicokinetics bioanalysis

** Qualifications & Competencies**:

- University degree in pharmacy or natural sciences (M/F/d), preferably Ph.D., or equivalent and extensive professional
- 8 years relevant pharmaceutical industry experience in the area of bioanalysis
- Strong scientific knowhow in the area of SMOL bioanalysis
- Additional expertise in the area of biologics, peptides, cell and gene therapy (or other modalities) is a plus
- Experience in working in international and multidisciplinary teams
- Proven experience in working relationships with external partners and in collaborations
- Strong organizational skills
- Several years of professional experience within a regulated environment (GLP)
- Broad understanding of global drug discovery and development
- Excellent networker and team player with proven networking skills
- Strong proficiency in English- **YOUR APPLICATION**- This is your opportunity to tackle the world’s biggest challenges with us: Maintaining our health, feeding growing populations and slowing the rate of climate change. You have a voice, ideas and perspectives and we want to hear them. Because our success begins with you. Be part of something big. Be Bayer.

**Location**:
Spain : Cataluña : Barcelona

** Division**:
Pharmaceuticals

** Reference Code**:
858033

  • Bioanalytical Outsourcing Scientist

    hace 5 días

    barcelona, España Bayer A tiempo completo

    Bioanalytical Outsourcing Scientist Position purpose: Being responsible for the placement, monitoring and scientific review of bioanalytical studies and method development/validation at Contract Research Organizations (CROs) as well as the assurance of the quality with respect to requirements by the regulatory agencies. Preparation of documents for INDs and...

  • Bioanalytical Outsourcing Scientist

    hace 1 semana

    Barcelona, España Bayer A tiempo completo

    At Bayer we're visionaries, driven to solve the world's toughest challenges and striving for a world where ,Health for all, Hunger for none' is no longer a dream, but a real possibility. We're doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and...

  • Bioanalytical Outsourcing Scientist

    hace 3 días

    Barcelona, España Bayer CropScience Limited A tiempo completo

    A global biotechnology company is seeking a Bioanalytical Outsourcing Scientist in Barcelona, Spain. This role involves overseeing the bioanalytical studies, ensuring quality with respect to regulatory requirements, and developing methodologies in collaboration with Contract Research Organizations. The ideal candidate will have a Ph.D. and over 8 years of...

  • Bioanalytical Principal Scientist

    hace 5 días

    Barcelona, España Nexus Life Sciences A tiempo completo

    My client is a CRO that supports pharmaceutical development from early preclinical phases through late‑stage clinical research, supporting the development of the next generation of therapeutics.Compruebe a continuación si tiene lo necesario para esta oportunidad y, si es así, envíe su solicitud lo antes posible.The principal scientist will provide...

  • Bioanalytical Principal Scientist

    hace 6 días

    barcelona, España Nexus Life Sciences A tiempo completo

    My client is a CRO that supports pharmaceutical development from early preclinical phases through late‑stage clinical research, supporting the development of the next generation of therapeutics. The principal scientist will provide high‑level scientific and technical leadership across bioanalytical activities, with a focus on LC/MS/MS method development,...

  • Bioanalytical Principal Scientist

    hace 3 días

    Barcelona, España Nexus Life Sciences A tiempo completo

    My client is a CRO that supports pharmaceutical development from early preclinical phases through late‑stage clinical research, supporting the development of the next generation of therapeutics. The principal scientist will provide high‑level scientific and technical leadership across bioanalytical activities, with a focus on LC/MS/MS method development,...

  • Lead Bioanalytical Scientist – LC-MS/MS, GLP/GCP

    hace 3 días

    Barcelona, España Nexus Life Sciences A tiempo completo

    A leading CRO in Sant Just Desvern is seeking a Principal Scientist to lead bioanalytical method development projects focused on LC/MS/MS. The role involves managing projects for NCEs, proteins, and peptides while ensuring adherence to bioanalytical guidelines. This position offers a salary of up to €60,000, strong growth prospects, and access to...

  • Lead Bioanalytical Scientist – LC-MS/MS, GLP/GCP

    hace 5 días

    Barcelona, España Nexus Life Sciences A tiempo completo

    A leading CRO in Sant Just Desvern is seeking a Principal Scientist to lead bioanalytical method development projects focused on LC/MS/MS.¿Está considerando presentar su candidatura para este trabajo? Compruebe todos los detalles en esta descripción del puesto y luego haga clic en "Solicitar".The role involves managing projects for NCEs, proteins, and...

  • HPLC-MS/MS Bioanalysis Scientist

    hace 3 días

    Barcelona, España Kymos Group A tiempo completo

    A leading contract research organization in Barcelona is seeking a Scientist specialized in HPLC-MS/MS bioanalytical methods. The role involves designing, developing, and managing bioanalytical methods and ensuring quality and timely deliverables. The ideal candidate has a degree in analytical chemistry, relevant experience, and a strong service-oriented...

  • Bioanalysis Scientist

    hace 2 semanas

    Barcelona, España Kymos Group A tiempo completo

    We are hiring a Scientist specialized in HPLC-MS/MS bioanalytical methods to set-up and compound quantification in biological matrices. The Job main missions will be: Design, develop and Supervise LC-MS/MS bioanalytical methods for compound determination in biological matrices (sample preparation, method set-up). Develop and validate new analytical methods...