Associate Project Manager, Immunoassay Development - Fujirebio Diagnostics Inc

Position Summary: The Associate Project Manager will be responsible for managing the development of immunoassays, which includes performing activities required for Design Concept, Design Feasibility, and Design Transfer to Manufacturing. This also includes managing the necessary tasks to enter a project/product into Design Control. Other responsibilities include planning and carrying out experiments in a GMP/GLP environment, interpreting results and summarizing data into project reports.

Essential Job Functions:

• Manages the development of immunoassays on automated platforms and the transfer of this technology to the manufacturing environment.
• Manage the formulation and assay development of new products in collaboration with external stakeholders
• Manages the transfer of new technologies, products and/or manufacturing processes into and out of the company
• Manages the training of Manufacturing operators, Quality Control technicians, and/or Quality Assurance personnel in specific areas of expertise.
• Assists in the scale-up and validation of new manufacturing processes, as needed
• Responsible for providing an environment which encourages the company's commitment to equal employment opportunity and the value of a diverse work force.
•  Follows all company environmental, health and safety policies, procedures and guidelines, and conducts work in a safe manner.
• Performs other duties as assigned.

Job Specifications (Knowledge, Skills and Abilities): 

•  B.S. / M.S. in Biological Sciences, with minimum of 5 years of laboratory experience in the diagnostic or pharmaceutical industries
• 1-3 years of project management experience
•  Extensive knowledge and work experience in immunoassay development, scale-up and/or manufacturing
• Previous supervisory experience preferred
• Experience with automated platforms such as Abbott Architect, Siemens Centaur
•  Knowledge and project management work experience
• Strong immunoassay development, design control, antibody selection/optimization and EIA experience
• Manufacturing, technical transfer and process scale-up skills highly desirable
• Instrumentation (e.g., HPLC, FPLC, spectrophotometer) skills highly desirable
• Experience with automated immunoassay analyzers desirable
• Strong protein modification/chemistry knowledge desirable
• Ability to supervise personnel
• Demonstrated leadership skills and a positive work-related attitude
• Excellent communication and interpersonal skills with both technical and non-technical personnel
• Ability to write clear, concise technical reports and attention to detail is essential
• Must be detail-oriented and thorough
• Ability to work with various software packages
• Ability to make presentations to various groups of individuals

We offer a competitive compensation and benefits package and a convenient suburban Philadelphia location.

We regret we are not able to respond to each resume received. Only those selected for an interview will be contacted.

Fujirebio Diagnostics is an Equal Employment Opportunity Employer