The Biologics Analytical Research & Development department in Dunboyne has an exciting opportunity for a Senior Specialist (Biochem). This is a laboratory-based scientific role tasked with solving complex analytical problems at the interface of biology, chemistry, and lab informatics disciplines to enable development of Biologics products. The successful candidate must function well and be able to collaborate in a fast-paced, integrated, multidisciplinary team environment. The Senior Scientist is expected to be a subject matter expert during execution of assay validations with expertise in analytical problem solving.
Role profile:
- Review execution of analytical method validations and transfers (among different sites, and between the company and CROs) and write technical protocols and reports.
- Review and execution of analytical testing of drug substance release, stability, and characterization for biologics under GMP/GDP.
- Analyse and optimize current lab/business processes in the laboratories and support implementation activities of the technologies and methodologies.
- Review execution of analytical method validations and transfers (among different sites, and between the company and CROs) and write technical protocols and reports.
- Collaborate with a global network of scientists to streamline and platform scientific methods entering Biologics AR&D at Dunboyne.
- Review and approval of analytical methods, SOPs, and other documentation.
- Technical Troubleshooting & Optimisation to support seamless method qualification.
- Support Quality Events to ensure execution in Biologics AR&D is compliant to GMP standards.
- Facilitate introduction of Cell Based Assay methods to the bioassay laboratory, including but not limited to the implementing of processes, onboarding of equipment, authoring of SOPs, and establishing training.
- Works in accordance with applicable internal company regulations: safety, health, and environmental protection.
- Coaching and mentoring for scientists within the department.
- Ensure correct and appropriate maintenance of the equipment, including calibration and qualification.
Your profile:
- Ph.D. in analytical chemistry/biochemistry or related field or M.S. with a minimum of 3 years of experience in the Biopharmaceutical Industry or Bachelor with 7 years of experience in the Biopharmaceutical Industry.
- GMP working experience and a working knowledge of regulatory requirements.
- Expertise in functional cell-based assays, binding assays e.g. ELISAs, tissue culture, antibody biochemistry and aseptic techniques.
- Ability to review and/or execute the qualification of release, characterization, and stability assays for testing of clinical trial material and in support of product and process development.
- Knowledge of Analytical Methodologies and sound scientific understanding of Critical Quality Attributes as well as data analysis and statistics for setting specifications.
- Expertise in method validations and technology transfers.
- Effective organizational and multi-tasking skills with strong oral and written communication skills.
- Team player with ability to support peer to peer coaching and lead technical discussion with subject matter experts, Operations, Quality.
- Applies strong scientific and technical knowledge to shape and deliver on pipeline innovation.
- Leverage broad expertise to drive strategic, therapeutic, regulatory, and scientific goals.
- Partners with Management to develop and execute scientific and enterprise strategy.
- Models and inspires a culture of collaboration, diversity & inclusion.
- Strong commitment to coaching, mentoring, and training scientists.
- Understanding of protein degradation mechanisms and link between analytical methodologies for analysis.
- Understanding of current manufacturing processes.
- Experience in ELISA methods, PCR, and analysis of various Biologic modalities (e.g., mAb, antibody-drug conjugate, fusion proteins, etc.).
- Certified in Lean Six Sigma or experience in Quality by Design.
We keep the patient at the very heart of all that we do and strive to find solutions and treatments for some of the world’s most challenging healthcare needs. We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment.
So, if you are ready to:
Invent solutions to meet unmet healthcare needs, Impact the future by driving one of the world’s leading healthcare companies, and inspire your team to reach their full potential and push the boundaries of science and technology, please apply today.
