Job Description
Main Duties and Responsibilities:
Research and Development
* Provide project leadership and management for all new Immuno products introductions.
* Plan with team and ensure execution of experimental activities.
* Lead delivery of projects accordingly to planned schedules.
* Assist Finance team in the costing of new products.
* Collaborate with Marketing for the delivery of new products (including but not limited to determination of product specifications, generation of data for technical literature)
* Generate data supporting the Vice President R&D in the measurement of departmental performance.
* Provide reports to Vice President R&D
* Manage technical collaborations.
General laboratory
* Liaise with laboratory management to ensure smooth execution of the lab activities.
* Eliminate waste in Laboratory processes (including but not limited to: documentation management, analytical testing, laboratory investigations etc) by actively seeking areas for continuous improvement
* Participate in safety initiatives in collaboration with Vice President and HSE officer (i.e. raising Safety Near Misses, Conduct Safety / Risk assessments as required)
Staff/Team
* Line management
* Provide coaching and development to the Immuno R&D team to improve capability and competency relating to R&D activities.
* Review performance against KPIs for all areas of activities and take the appropriate actions to rectify shortfalls (yearly reviews, disciplinary actions – when required)
QA
* Work closely with the QA team for maintaining ISO13485 standards.
* Work with the Vice President R&D in the continuous improvement of the Design Control process
* Ensure Standard Operating Procedures remain compliant with current QMS requirements.
Technical/Sales support
* Provide active leadership and technical support for Immuno products.
* Support sales team with technical sales to customers
* Provide detailed product trouble shooting/optimization, general guidance to customers and manage local collaborations.
Qualifications:
* PhD and 10+ years experience in Life Science industry developing new antigen/antibody products or developing immuno-assays
* At least or equivalent to 2 years experience in successful team management and performance evaluation
* Prior experience with ISO13485
* Hands-on experience in diagnostic immuno-assay development and troubleshooting (CLIA, FIA, ELISA…)
* Expertise in a broad range of non-bacterial expression systems such as mammalian (HEK,CHO), insect (S2) or yeast (Saccharomyces cerevisiae, Pichia pastoris…).
* Demonstrated experience in protein/antibody purification and characterization
* Good understanding of protein design and engineering and associated methodologies
* Experience with statistical analysis and/or Design of Experiments methodologies
* Leadership ability with demonstrable employee performance management
* Ability to develop team and create team engagement.
* Experience of QMS (eg GMP, GLP, ISO9001 or ISO13485) in a science laboratory environment
* Workplace Health & Safety: Knowledge and experience of obligations under the current legislation and practical application in the workplace.
* Strong Communication Skills both verbal and written with ability to report and communicate clearly and concisely ideas and concepts