An exciting new opportunity has arisen to join the company as a Technical Sales Specialist within the APAC Commercial Team of BioReliance® Contract Testing Services. Based on a strong understanding of our current and anticipating future customers, market and regulatory needs, the Technical Sales Specialist position is responsible for providing technical and regulatory support to customers in the biologics market in APAC (excluding China). The candidate will serve as an experienced technical expert in CMC biological safety QC testing for a broad range of biologics, including recombinant proteins, vaccines, cell and gene therapies, and other novel biotherapeutics for large pharma and biotechnology companies. For this expert-level technical position, it would be an advantage to have a solid working knowledge of biotechnology manufacturing principles and processes.
Serve as the technical trusted advisor for biosafety testing programs (e.g., sterility, endotoxin, mycoplasma, adventitious agent assays) across development and manufacturing stages.
Translate customer biosafety needs (assay selection, validation strategy, GMP/GLP compliance) into Germany solutions and workflows.
Be an expert in Regulatory testing requirements (ICH guidelines, GMP, GLP) and support client's regulatory filing (IND, BLA, Commercialization filing).
Collaborate with Applications, Regulatory, and QA teams to troubleshoot, optimize assays, and support method transfers to clinical/commercial labs.
Develop technical account plans with stakeholders, risk assessments, and milestone-based post-sale technical support for biosafety testing programs.
Minimum requirements:
Preferred requirements: