The Staff Scientist / Field Investigator is a specialized position in the APJ regional Field Applications Scientist (FAS) organization.
The 2 main roles are to : (a) Lead the launch and expansion of the Field Investigation Program (FIP) for Single-Use Technologies (SUT) products in APJ region, and to (b) Complement local technical teams and fills support gaps as a senior-level FAS.
Be an integral part of a high performing Field Applications organization with a strong collaborative culture that bridges across businesses, functions and regions.
Key Responsibilities :
Field Investigation Program (FIP)
Leads the launch and expansion of FIP for Single-Use Technologies (SUT) products in APAC.
Drives the adoption of FIP processes and shared toolboxes in APAC as aligned globally; Builds and scale FIP capabilities for regional self-sufficiency and support future business growth.
Works with Quality Engineering to develop and execute investigation plans and assist in development of corrective action plans of quality issues related to customer complaints, corrective action requests and quality improvement requests.
Works with local Field Investigators to execute field-based root cause investigations with customers.
Interface directly with customers and internal groups as needed to ensure good execution of investigative plans, risk and impact assessments, using the proper tools and aligned with global Complaint Handling Process.
Ensures pragmatic solutions that meet key customer needs and address the identified problems. Communicates recommendations and decisions across the organization.
Collaborates with local Field Investigators to interface with customers regularly to ensure that investigations, root causes, and corrective measures are effective in meeting expectations and preventing re-occurance.
FAS technical engagement and capability development
Complement local SUT FAS pre- and post-sales support activities with deep technical expertise.
Partners Technical Sales Specialists (TSS) of SUT and other businesses to develop workflow solutions for pre-sales and post-sales discussions with customers.
Drive product and process change communications to improve customer application and relationships.
Identify and address regional technical training needs
Participate in external technical conferences and industry body forums.
Contribute to global SME (Subject matter expert) and SPOG (Single point of contact) networks.
Champion Practical Process Improvement (PPI) initiatives, e.g. Gemba.
Develop synergies across internal manufacturing and demo sites.
Minimum Requirements :
Bachelor's degree in Life Sciences (Biochemistry, Biotechnology, Engineering), Masters or PhD degree preferred.
Minimum of 7 years hands-on experience in Single-Use Technologies, within the Biotech, Biologics, and / or Biopharmaceutical industries in a technical capacity, and ideally served customer-facing / field application roles.
Deep knowledge of bioproduction workflow process development and scale-up and cGMP production.
Experienced with leading technical trainings and authoring technical application notes / publications / posters, and giving technical presentations at international technical conferences.
Strong English communicator, and demonstrated cross-cultural influencing skills in Asia Pacific region.
Preferred Skills :
Knowledge of Quality Management System tools, continuous improvement methodologies, in-depth understanding of products and processes.
Experience working with ISO 13485 or ISO 9001, and 21CFR820
Experience with handling product complaints, quality improvement requests, investigative work, Corrective and Preventive Action (CAPA).
Understanding of plastics materials and properties, manufacturing processes, and assembly of bioprocessing Single-Use products.
Demonstrated cross-cultural influencing skills in Asia Pacific region.