Analytical Chemist
6 days ago
Contract Type: Permanent
Closing date:
Reference: VN1673
- 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 SummaryAnalytical chemist in a team with a broad technical portfolio of technics such as chromatography (i.e., GC, LC), and mass spectrometry (i.e., LC-MS/MS, GC-MS/MS). The role will aim at building functional capability and capacity for efficient execution of in vivo toxicology and studies at the facility. In addition, the analyst will ensure scientific and technical rigor in the responsible areas to support company's science and innovation pipelines.The analytical chemist will be part of a team where he will have to work jointly with operators having different levels of expertise. Communication, proactiveness, and self-management will be essential in order to deliver functional execution of in vivo studies on time and on budget whilst ensuring compliance with pertinent guidelines and scientific standards (i.e. OECD GLP, ISO, AVA, AAALAC, OECD TGs and USFDA).The analytical chemist will also have to 1) plan resources and timelines; 2) update and maintain equipment, workflows, and laboratory information systems; and 3) develop and implement new assays, test methods, equipment, workflows, and systems.**Responsibilities**:
Lead the organization's effort on test method development/optimization and validation focusing on chromatographic systems (i. e. GC, LC) and mass spectrum (i.e. LC-MS/MS, GC-MS/MS) for the identification and quantitation of chemical constituents and metabolic biomarkers in complex matrices.
- Provide technical leadership to the Bioanalytics department in the relevant technical domain; conduct training to the junior analysts and new hires; provide first-line technical support to day-to-day smooth quality testing. Act as a study director for GLP studies in the Bioanalytical department. Ensure the methods, equipment, systems, and workflows are fit for purpose, up to date, and efficient.
- Keep track of the technological advancement in the field, assess, adopt, and provide expertise for developing and implementing new/innovative techniques, assays, methods, and capabilities that will enable/accelerate the company's scientific project portfolio execution in particular for scientific substantiation of RRP products and exploration of adjacent therapeutic areas.
- Represent the functions to coordinate and liaise with cross-functional units and stakeholders (HODs, SDs, Sponsors, global counterparts) on the planning, resourcing, execution, data analysis, and reporting of in vivo (and ex vivo, in vitro) pre-clinical studies within R&D. Foster a culture of collaboration and enable frequent technical exchange across the network.Ensure the day-to-day laboratory operation is smooth and efficient, and devise and implement continuous improvement projects to keep up the laboratory operation and systems to the best practices.Participate in establishing and maintaining an adequate, current, and effective QMS system and assume ownership roles for the business area, systems, equipment, and SOPs when applicable. Support quality/compliance inspections and audits conducted by both internal and external parties.
- Back up to the manager of bioanalytical & in vitro operations to review and approve test results and assist on study planning for the Bioanalytics department in workflow optimization, resourcing, procurement, etc.**Requirements**:
PhD in Chemistry, Life Science, or related technical/scientific discipline is preferred.
- Minimal 5 years relevant professional experience with technical and scientific knowledge with a focus on analytical and bioanalytical method development, validation, and laboratory operations, with a CRO, R&D unit within pharmaceutical or healthcare industries, or translational academic research organizations.
- In-depth knowledge preferably with hands-on experience on a broad range of analytical and bioanalytical platforms and workflows in toxicology studies and life science research, i.e. LC/GC, LC-MS/MS, and other characterization tools for chemical entities.
- A good understanding on regulatory guidelines such as FDA,
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