Description

Job Purpose: Leads the lab team to carry out analytical work within the assigned projects to execute activities associated with the conduct of a clinical trial. Independently leads or supports trial activities and drives laboratory productivity. This includes conducting analyses of biological samples for external clients using various equipment. Main areas of responsibility: Oversight and leadership:
– Drive, by motivating and directing the Berlin lab team: – Determine where efficiencies can be made and propose suggestions for improvement.
– Constantly looks for opportunities to improve processes, procedures and systems.
– Ensures that the lab techs properly operate the lab in close cooperation with the senior scientific team.
– Drives processes within the Lab Technician team.
– Leads and oversees Lab Technicians that are responsible for the laboratory operations and operational delivery of studies.
– Ensures that the Odoo planning app is accurately and efficiently updated.
– Provides support to up to 10 team members and oversees their work and training.
– Assumes a leadership role in training team members on laboratory-based aspects of multiple studies, methods and company procedures.
– Ensures study teams work with minimal errors (data and paperwork) and supports members in executing preventative actions.
– Ensures the upkeep of Study Files (including documentation) and identifies deviations within the study in the raw data.
– Oversees and drives the performance of team members while setting an example for others; is a strong driver of teamwork.
Laboratory related:
– Performs laboratory tasks associated with Method Development and Validation, under the supervision of the Senior Scientists.
– Is able to work on multiple platforms with minimal supervision.
– Is able to troubleshoot instruments on a technical level.
– Generates revenue by processing clinical samples and performing Method Development and Validation work as per Method Sheets.
– Manages equipment which includes being custodian of a range of equipment and identifies issues, including troubleshooting.
– Oversees and coordinates the ordering, planning and management of reagents (includes stock maintenance).
Ad-hoc:
– Strong adherence to regulatory compliance and safety requirements, involving good clinical laboratory practices (GCLP), SOPs, Health & Safety policies, and other related documents.
– Assesses systems being used, identifies gaps and identifies areas for improvement.
– Writes, maintains and reviews SOPs and forms

Qualification/Experience required: – A minimum level of vocational training as a Medical/Biomedical laboratory technician or “Medizinisch-technische/-r Labor-Assistent/-in/Laboratoriumsassistent/-in – MTLA” (Berufsausbildung/IHK Prüfungszeugnis – Chamber of Commerce and Industry (CCI) examination certificate) with 4-5 years of experience in the equivalent work or in a relevant technical role.
– On-going general International Organization for Standardization – ISO, Good Clinical Practice – GCP and Good Laboratory Practice – GLP awareness training needs to be provided to all staff. The job holder needs to ensure that he/she is up to date with the available training.
– Experience in pipette handling, following protocols, and using basic equipment (e.g., centrifuges, biosafety cabinets, incubators). Can independently troubleshoot equipment-related problems and perform multiple assays.
– Working within a good practice (GxP) and/or Good Clinical Laboratory Practice (GCLP) accredited environment.
Previous experience at a CRO.
– The ideal candidate should have prior experience working with analysers (e.g. MSD, Epoch).
– Someone who has a strong understanding of the day-to-day operations within a laboratory and who has a strong ability to lead, train others, and influence their productivity. Skills and Competencies required: – On-going professional development is strongly encouraged; this may take the form of sponsor-funded seminars, workshops, society meetings, congresses, etc.
– Good knowledge of written and spoken English..

– Competitive market salaries in each country
– Discretionary bonus based on performance each year (subject to company performance and budget)
– Annual Inflationary increases to salary (subject to budget and inflation)
– Training and Development opportunities
– Identifying a Career path for promotion potential and working with Managers to determine milestones to be achieved.
– Statutory/Public Holidays – flexible to be taken when chosen or on the actual public holiday.
– Regular employee engagement and wellness surveys
– Regular communication and engagement through BambooHR announcements and Town Hall meetings
– Strong applicant tracking system for recruitment and ensuring the onboarding process is an enjoyable experience for all new employees.
– End of year celebratory functions.
– Social events & end of year function
– Family friendly leave for sick, paternity, maternity and parental