Are you looking for an opportunity to develop your professional career in a CDMO Analytical Methods Development Department?
The successful candidate will join 3PBiovian as an AMD Physicochemical Laboratory Technician.
Responsibilities:
* Coordinate developments, implementations, qualifications and transfers of physicochemical analytical methods and n this activity includes the design of experiments, review of documentation and associated data and the generation of protocols, reports and / or presentations required.
* Supervise the execution of sample analyses carried out in the laboratory, as well as the review and communication of the results obtained.
* Develop standard operating procedures related to analytical methods, as well as other procedures related to the operation of the area.
* Prepare protocols, reports, as well as final reports of stability studies, forced degradation studies, characterization of reference materials, re-testing of reference materials, investigations and other non-GMP studies that are not included in the above descriptions.
* Manage stability studies, sample and sample location control, analysis times and execution of analytical runs.
* Participate in technical meetings.
* Maintain fluid communication with the departments involved.
* Participate in the proposal of operational improvements oriented to the quality and efficiency of the work.
* To write the transfer protocols of the Physical-Chemical methods.
* Technical responsibility for the activities developed within the framework of the projects assigned to them.
Assesment criteria:
* University degree or equivalent in related areas: Biochemistry; Biology; Biotechnology; Chemistry, etc.
* Valuable but not necessary Master's Degree related to the area (Chemistry; Biochemistry; Biotechnology; Biology, etc.).
* Valuable but not necessary Phd with specialization in Biotechnology.
* Advanced level of English Level, C1 / Advanced. Language certificate not required; placement test will be administered.
* Open to work in shifts.
Between 3 and 4 years of experience in:
* Pharmaceutical, biopharmaceutical, biotechnological sector or research centers.
* Analytical techniques such as: HPLC; UPLC; Fluorescence; DAD; UV - VIS, UV Detection; PDA/dad; ELSD/CAD/MS.
* Experience with recombinant proteins, mAbs, Biosimilar, ADCs.
* Participation in analytical method development design.
* Method validations (valuable).
* Handling of Agilent equipment with Empower 3.
* Supervision and coordination of personnel.
* Participation in technical meetings with customers.
* Valuable knowledge in GMP regulations and in the qualification/validation of analytical methods.
Why 3PBiovian?
* A permanent and stable position in a competitive growing company.
* A competitive time off package with 39 paid days of vacation.
* Additionally you will have an extra day off on the 26th of December.
* Flexible compensation plan, allowing all employees to allocate up to 30% of their gross annual salary to daily services exempt from income taxes (childcare, health insurance, academic training etc.)
* Company benefits club, which allows 3P Biovian employees to obtain exclusive prices and discounts on a multitude of products and services (Booking, FNAC, Rituals, El Corte Inglés etc.)
* All new hires who reside outside Navarra are provided with a relocation service and/or assistance.
* ...And so much more!
Why us?
We know it takes people with passion and a shared purpose to manufacture advanced medicines.
We specialize in process development and cGMP manufacturing of biologics and cell therapy products using microbial and mammalian expression systems. We are with you on your biologics journey, growing with you and supporting you with process and analytical development, preclinical and clinical supply, and commercial production. With a focus on biotechnology applications in both human an animal health sectors, we offer customized solutions that meet the specific needs of all our clients
From development to product delivery, we are with you on your biologics journey. We are a leading global CDMO and preferred partner for pharmaceutical and biotech companies. We have what it takes to help you improve lives.
It's within us.