Scientist, in Vitro Operation

Contract Type: Permanent

Closing date:
Reference: VN1670
- Who we areVectura Fertin Pharma’s ambition is to become a market-leading wellness and healthcare business. Formed in March 2022, the business brings together two unique organizations: Vectura, experts in inhalation technology and Fertin Pharma, experts in oral and intra-oral delivery systems.
- We are driven by the exciting and unique goal of addressing unmet patient and consumer needs by revitalizing, repurposing, and reimagining existing therapies to better serve people in taking care of their health and well-being.What we will deliverWe focus on the development of a proprietary pipeline of wellness and healthcare products, with a specific focus on highly differentiated products that address unmet medical and consumer needs.
- By leveraging our unique and enabling R&D capabilities, we are building a pipeline that includes inhalable medicines, nicotine replacement therapies (NRT), and consumer wellness products.Role SummaryThe Cell biologist will establish and execute in vitro toxicology and pharmacology studies. This will include regulatory in vitro toxicological assays such as microbial mutagenicity assays, as well as cell-based cytotoxicity and genotoxicity assays, in accordance with the OECD GLP requirements.
- In the team, the Cell Biologist will also be responsible for providing downstream cell and biochemical assay development, validation, and analysis services to support organization’s in vivo study execution, which includes a battery of clinical pathology assays, flow cytometry, and ELISA assays.
- The Cell Biologist Scientist will also lead the organizational effort in developing and implementing state-of-the art organotypic cultures and new in vitro capabilities to advance the regulatory-compliant ready research capability in line with the 3Rs principle of animal research adopted by the organization.**Responsibilities**:
Responsible for establishing, maintaining and improving the technical expertise in the domain of in vitro toxicology and genotoxicology, keeping up to the scientific and regulatory advancement in the field. This may include, but not be limited to microbial mutagenesis assay (Ames), cell-based viability assays (neutral red uptake) or mutagenesis assays (mouse lymphoma assay, micronucleus assay).
- Act as Study Director for the in vitro toxicology and pharmacology studies executed at the facility, responsible for the overall scientific conduct of the study, from the conceptualization to the closure. Study Director plans, manages and reports the studies in accordance with pertinent regulatory guidelines (i.e. OECD GLP Principles and Test Guidelines) and to customer's satisfaction.
- Coordinate and liaise with cross-functional units and stakeholders (HODs, SDs, Sponsors, global counterparts, external clients) on the planning, resourcing, execution, data analysis and reporting of relevant study phase (i.e. clinical pathology, flow cytometry and biochemical assays) for the in vivo pre-clinical studies.
- Keep track with the technological advancement in the field, assess, adopt and provide expertise for developing and implementing new / innovative techniques, assays, methods, capabilities that will enable / accelerate company's scientific project portfolio execution and/or will meet external client needs.
- Plan and conduct studies using project management tools within the timelines and budget; anticipate variations and provide information about changes on a timely basis. May have client facing opportunities.
- Support quality / compliance inspections and audits conducted by both internal and external parties.**Requirements**:
PhD in Life Science, Biology, or related technical / scientific discipline.
- Minimal 5 years relevant professional experience with in-depth scientific knowledge focusing on in vitro research and/or toxicology studies with a CRO, R&D unit within life science industry, or translational academic research organizations, preferably in a regulated environment.
- In depth scientific knowledge with hands-on experience on in vitro research and/or pre-clinical in vitro toxicology research
- Independent ability to develop/optimize/validate cell-based and/or microbiological assays. Understanding on regulatory guidelines such as FDA, ICH, OECD GLP and TGs related to in vitro toxicology and genotoxicity, and quality management system is preferred. Experience with leading R&D project. Self-starter and highly motivated individual with excellent communication and influencing skills.Why Join Us?We are bound by our shared passion for making a positive impact on the lives of patients and consumers. Vectura Fertin Pharma is a place where you can help shape the future of healthcare, where we collaborate, support, and inspire each other to achieve the best outcomes. As a growing business, we can offer a wealth of opportunity to develop your career both locally and in international settings.
- We embrace hybrid and flexibl