Principal Scientist/ Scientist Process Testing and Management Company: Takeda Pharmaceuticals International GmbH Location: Shohan iPark, Japan Job Description: We are unwavering in our commitment to patients.
With the patient at the center of everything we do, we continue to innovate and drive changes that will better their lives.
We're looking for like-minded professionals to join us.
As a global industry leader, we are united by our four priorities: Patients, Trust, Reputation, and Business, and our shared values of Integrity, Fairness, Honesty, and Perseverance.
BMTJ (Biotherapeutics Manufacturing Technology Japan) is one of the major sites in global Biotherapeutics Process Development, organized from bioprocess development group and biologics manufacturing group.
BMTJ is responsible for biologics manufacturing processes throughout the phases, which include: Process development Scale-up from lab scale to manufacturing scale Drug substance manufacturing for clinical supply Regulatory submission to health agencies As biologics evolve day by day, we are looking for people who are passionate about new technologies and innovative challenges.
BMTJ is located in Shohan iPark and strongly collaborates with colleagues in Vienna for biotherapeutics development globally.
Role Responsibilities: Conduct acceptance testing of raw materials used in GMP manufacturing and process control of GMP manufacturing therapeutic antibodies and biopharmaceuticals by new modalities.
Promote innovation through collaboration with domestic and international research institutes for analytical processes.
Support testing activities of biopharmaceutical drug substance at both scale and GMP manufacturing.
Prepare and review technical documents (e.G., development reports, process transfer protocols, regulatory documents).
Lead technical transfer to manufacturing site of analytical processes by working closely with both internal and external partners.
Provide technical leadership in solving clinical drug substance process issues.
Work in a global team to advance biotherapeutics pipelines.
Contribute to the innovative development of advanced technology, latest equipment and facility, and digitalization to enhance efficiency of biotherapeutics process and manufacturing.
Minimum Requirements/Qualifications: M. S. / M. A. or higher degree in biology, biotechnology, chemistry, chemical engineering, or related field, with 3 to 5 years of relevant experience.
B. S. / B.
A. in biology, biotechnology, chemistry, chemical engineering, or related field, with 5+ years of relevant experience.
Experience with microbial-related testing: microbial limits, sterility testing, endotoxins, and identification of environmental bacteria.
Experience as a leader and expert in the analysis function of process development.
Validation and testing experience of viral assays for cell and gene therapy.
Knowledge in bioproduction using animal cells or microbials.
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