Do you want to watch clinical development change, or do you want to be the one to shape it?
Because we're hoping you're here for the latter.
Who are we?
We Are PRA Bioanalytical Labs, with locations in Lenexa, KS USA and Assen, Netherlands, EU.
We are part of the 16,000+ employees strong for PRA Health Sciences, operating in more than 90 countries. We are committed to saving lives and we are constantly striving to be the best at what we do. Our impact is real and we see it every single day. We help get life-saving drugs into the hands of those who need them most.
Who are you?
You are a leader.
You are a goal oriented, analytical and science minded individual. You are excited to be a key part of facilitating the development of life-enhancing therapies.
Still here? Wonderful! Because the Bioanalytical Team Lead is an excellent opportunity to drive your career forward in the field of drug development research. You will be on the front-lines of contributing to cutting edge data from non-clinical through late-stage clinical research projects for tomorrow's most important therapies. Come join our dynamic team and be a part of the evolution of medicine; and to watch your career evolve with it!
What will you be doing?The Bioanalytical Team Lead achieves successful delivery of operational activities (management, equipment, and data review) or supporting operational activities (sample receipt/storage/tracking, equipment maintenance, purchasing, shipping and inventory control, equipment validation process and other support functions) by meeting internal and external client or regulated requirements. Oversees the management of validation and production or operational support staff to ensure compliance with the study plan, protocol, and applicable regulations, and SOPs. Ensures equipment ismaintained according to the SOPs. Lead and provide overall functional management of staff including performance management cycle and annualreviews, review and approval of timesheets, PTO and planning of staff schedules.Preparation, execution and supervising of laboratory projects within the team (under the final responsibility of projectmanager), so they meet the applicable regulatory and quality standards and are completed within budget andtimelines.Ensuring that documentation and materials are available on time for the projectsOverseeing maintenance and calibration of equipment and resourcesReviewing of study related documentsProviding technical guidance and instructions to team membersInforming the project manager regarding the implementation and progress of projectsParticipating in meetings with project team membersAssess, interpret and evaluate the test results, or applicable facility related systems results for operational supportMonitoring levels of education, so that an adequate level of knowledge and skills are maintained within the teamRegularly organizing and chairing team meetingsMonitoring compliance with SOPs within the departmentMonitoring the efficient use of materials, from an economic and ethical point of viewMonitoring of cleanliness and order of laboratory areasWhat do you need to have?Bachelor's degree or its international equivalent in analytical chemistry, biochemistry, pharmacy or other laboratory related degree.3-5 years of laboratory experience in a bioanalytical laboratory.Experience and knowledge of laboratory execution procedures.Knowledge of Bioanalysis.Knowledge of GXP guidelines.Knowledge of Laboratory equipment.Ability to provide instruction to Analysts in the context of projects.Reporting details and results to the Project Manager Coaching team members from various levels.Working with complex laboratory systems.Working with computers serving to process data analysis (Excel, Word and equipment-oriented software).Working with laboratory instruments and equipment. Provides leadership to the team to facilitate solutions to difficult assay development, sample analysis issues or operational challenges.Solutions are thorough, practical and consistent with PRA's objectives.Recommends and implements enhancements to processes and SOPs.Formulates and defends proposals and recommendations to project manager or test facility management.Read, write and speak fluent English; fluent in host country language required.To qualify, applicants must be legally authorized to work in the United States, and should not require, now or in the future, sponsorship for employment visa status.PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.