Careers
Development Scientist
Requisition Number: DS-2114-001
Department: PD
Position Summary: The individual will be responsible for the development of immunoassays, which includes performing the necessary tasks to enter a project/product into Design Control, performing Design Verification and supporting Design Validation and Design Transfer.
Other responsibilities will include planning and carrying out experiments and studies in a GMP/GLP/GCP environment, interpreting results and summarizing data into project reports.
Essential Job Functions:
- Responsible for the coordination and testing of Lumipulse products to support clinical investigations and regulatory submissions
- Performs a major role in the development of immunoassays on automated platforms and in the transfer of this technology to the manufacturing environment.
- Assist in the transfer of new technologies, products and/or manufacturing processes into and out of the company.
- Assist in the scale-up and validation of new manufacturing processes as needed.
- Assist in the training of manufacturing operators, quality control technicians, and/or quality assurance personnel in specific areas of expertise.
- Other duties as assigned.
This is not an exhaustive, comprehensive listing of job functions. May perform other duties as assigned.
Principal Relationships:
Contacts Inside the Company: Quality, Manufacturing, Planning, Product Development, Regulatory Affairs, and Clinical Affairs personnel
Contacts Outside the Company: Equipment manufacturers, raw material vendors, companies involved in technology/product transfer and others as necessary.
Supervisory Responsibility: None
Supplementary Information:
Education & Related Experience: B.S./M.S. degree in the Biological Sciences and at least 3-5 years of laboratory experience in the diagnostic or pharmaceutical industries.
Special Skills, Training or Certification: The qualified individual will have knowledge and work experience in immunoassay development, design control, antibody selection/optimization and EIA. The ability to write clear, concise technical reports and attention to detail is essential.
Physical Requirements (as defined under the American w/Disabilities Act): Ability to travel nationally and internationally, ability to work with potentially hazardous materials, manual dexterity and ability to do visual inspection
Significant Safety or Working Considerations: None.
We offer a competitive compensation and benefits package and a convenient Malvern location. To apply, email resume to HR@FDI.com.