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Based on a strong understanding of current and anticipating future customer, market and regulatory needs, the Senior Technical Specialist of Field Technical Services is responsible for providing scientific excellence for the Asia Pacific Biologics customer. He/She will identify emerging products, technology trends, custom requirements and champion custom activities that will grow the business from the Asia Pacific region. The job holder performs duties independently whilst working in collaboration with global teams including UK and US Field and Operational Development Services, Operations, Sales & Marketing, and Quality Assurance. The STS reports to the Global Head of Field Development Services.
ESSENTIAL JOB FUNCTIONS
- Act as the technical expert in the Biologics CLC, LRT and VC areas for the BioReliance Asia Pacific customers, providing scientific and technical thought leadership directly to the client. Act as the scientific support for clients; providing technical input into relevant programs with ongoing scientific support with custom projects and ensure scientific and technical solutions meet current regulatory expectations
- Support to Sales and Operations for major customer acquisitions by providing scientific and regulatory support, generate custom proposals to win new orders. Owns the scientific and regulatory relationship with key clients.
- Must have multi-scientific knowledge: Microbiology, Molecular Biology, Virology, Immunoassays and work closely with other Field DS and Operational DS representatives
- Understand regulatory direction for different agencies within AP region (KFDA, CFDA, MLHW) and ensure knowledge and understanding of global regulatory needs
- Monitor industry trends to ensure that BioReliance remains at the forefront of scientific advancements in the field of Biologics; review and recommend potential technical developments to wider business
- Interact proactively and productively with colleagues within the global commercial team and senior leadership team
- Promote a culture of continuous improvement within Biologics act as champion on initiatives and/or projects to drive improvement in quality and / or client service
- Act as scientific thought leader for the BioReliance business in the wider Asia Pacific region
- May perform other related duties as required and / or assigned
- Complies with company health and safety regulations and procedures
Who you are:
- Ph.D. in Life Sciences relevant scientific field or equivalent experience.
- At least 8 years of relevant experience, ideally balanced in biologics development and/or manufacturing, quality and technical operations within a global, multi-site environment.
- Relevant industry experience in a pharmaceutical, biologics and/ or medical device environment is required. Experience within a regulated environment and ability to interact effectively with regulatory agencies.
- Strong interpersonal experience with a demonstrated ability to lead and influence teams and individuals is required
- Strong negotiating skills required. As “voice of the expert”, provide effective communication and working relationships with customers.
Knowledge and Skills:
- Excellent verbal and written communication and presentation skills in both English and Chinese (or equivalent Asian language)
- Demonstrates strong client facing skills
- Willingness to work on weekends, and off hours
Functional area: Strategy & Business Development
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