Team Leader Quality Control Laboratory
We are a Contract Development and Manufacturing Organization (CDMO) with over 20 biotech companies worldwide that have placed their trust in us. We develop and manufacture lentiviral vectors as a European leader working under both EMA and FDA standards. The lentiviral vectors produced by VIVEbiotech are used to treat a range of disorders, including haematological and solid cancers, and rare diseases.
We are looking for you to be part of our Team!
We are looking for a Team Leader Quality Control Laboratory to fill a key position reporting directly to the Quality Control Manager. You will be responsible for managing the daily operations required for the analytical characterization of the final and intermediate products generated during the manufacturing process.
Your main mission will be to ensure the proper release of analytical test results while maintaining the highest quality standards. He/she will review the documentation associated with each assay (CQMs and records) on time, ensuring the correct traceability of samples and guaranteeing full data integrity.
The Quality Control Team leader will ensure the correct coordination and integration of his team with the other areas of the department such as Environmental Control, Analytical Development and Laboratory Management Support. As part of his/her mission, he/she will report on activities and incidents to the QC and Analytical Development Manager.
The QA Team Leader will work closely with the Environmental Control, Analytical Development and Document Management areas to ensure the smooth running of the daily operations of the department. He/she will coordinate analytical assay execution activities with the USP and DSP Production and Development departments. Coordinate quality system management activities (Deviations, CAPAS and change controls) with the Quality Assurance area. You will maintain contacts with external suppliers and participate in the evaluation of DEMO equipment for the incorporation of new technologies in the department.
We value having more than 3 years of industry experience in the life sciences or pharmaceutical area. Experience working with GMP or GLP (E) standards. Demonstrable experience in leadership and team management: training, mentoring and supervision of laboratory personnel.
- Generate the scheduling and planning of routine activities related to the execution of analytical assays (molecular biology and physical chemistry).
- Review and complete CQMs generated during assay execution by QC operators (Molecular Biology and Physical Chemistry).
- Align the execution of routine QC tasks with batch planning by coordinating with production, DSP/USP and QA teams.
- Report to the department manager on activities and incidents highlighted during routine work.
- Participate in the drafting of the sampling plan for batch manufacturing with respect to analytical assay implementation.
- Work closely with laboratory management support team to manage OOS investigations, deviations, CAPAs and change controls generated during routine laboratory work.
- Coordinate with Laboratory management support team for proper laboratory management (housekeeping, cleanliness, good laboratory practices, equipment usage, data integrity, waste management, etc.).
- Lead and follow up on OOS investigations/deviations/change controls related to QC activities.
- Coordinate with the analytical development group on the implementation and validation of analytical test methods.
- Participate in the drafting, maintenance and management of department SOPs.
- Continuously track and monitor assay execution across areas and implement strategies for efficiency improvements, failure reduction and elimination of bottlenecks in the execution of all assays.
- Provide support and assessment in the selection and purchase of QC laboratory equipment.
- Manage the team of people in the QC group by planning their personal development and following up on performance reviews.
- You have a University Degree related to the area of Molecular Biology, Biotechnology, Biomedicine, Pharmacy… We value PhD.
- You have worked at least 3 years in the industry in the life sciences or pharmaceutical area and have led and managed laboratory work teams under your charge.
- You have knowledge of Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP).
- You have a minimum level of English B2 desirable C1.
- You know the biopharmaceutical techniques based on cell and molecular biology such as ELISA, flow cytometry, PCR, cell culture, potency tests (P).
- You are a responsible and rigorous person, orderly and analytical.
- You like to work to achieve the objectives of the team and you are proactive, leading the achievement of results and with a cooperative attitude.
- You work autonomously, knowing how to organize yourself when there is pressure of results and dates with many simultaneous objectives.
- Your orientation to high quality is high (excellence and self-demanding).
- You always show a positive attitude towards change.
- You have good oral and written communication skills.
We offer you
- You will have continuous career development that will help you develop your talent throughout your entire professional career.
- You will participate in innovative projects in constant technological update.
- You will have a competitive salary according to your profile for this position.
- You will have a flexible timetable, with the support you need to conciliate and balance your personal and professional life.
- You will be part of an expert, young, dynamic, innovative and enthusiastic team united by a common purpose, to accompany our clients to go ahead in the cure of diseases.
- We will support you in your personal change process, if you come from another region and wish to come to live in Donostia-San Sebastián (accommodation, support in the job placement for members of your family unit, schooling,…).
- You will enjoy a professional work environment, which is really distinguished by our humanity and closeness. And where we take care of diversity and inclusion. Diverse viewpoints, your curiosity, bring diverse capabilities that strengthen our focus and fuel our growth.
- We are proud on offering equal opportunities and a close, welcoming environment. All people receive consideration for our vacant positions, without distinction of gender, age, race, religion, identity, sexual orientation, origin, disability or any other characteristic.