Quality Senior Scientist

Primarily focused on laboratory testing in a GMP area, with a focus on execution of test methods in support of assay validation.

RESPONSIBILITIES MAY INCLUDE:
Providing Quality Review/Oversight of site GMP documentation related to the operation of a vaccine manufacturing facility to ensure compliance with global regulatory agencies and quality standards.
Performs testing including, but not limited to clinical and/or commercial product, raw materials and validation samples.
Displays strong investigative or technological orientation with independence for design of projects/studies.
Organizes and provides written and/or oral presentations of work with minimal input.
Analyzes and interprets results, makes decisions regarding the accuracy, completeness and compliance.
Responsible for final authorization/approval/release of documentation/equipment/processes.
Assessing existing situations and suggesting improvements in the Quality systems to increase compliance throughout the facility.
Plans and leads projects to ensure their timely completion.
Provide guidance/coaching to junior colleagues.

REQUIRED:

Minimum: 5 - 8 years of manufacturing, quality or engineering experience in the biotech or pharmaceutical industry. Good Manufacturing Practices (GMP)

EDUCATIONAL BACKGROUND:

Minimum: BS/BA Degree in Science/related field or other appropriate education/experience in biotech or pharmaceutical industry.

DESIRABLE: University Degree in the field of Engineering, Microbiology, Chemistry, Biotechnology, Biochemistry or Pharmacy or other appropriate education and experience in biotech or pharmaceutical industry is preferred.