Process Development Scientist

The Process Development Scientist will be responsible for supporting trouble shooting method related issues across various analytical platforms associated with microbiology as well as compendial methods related to microbial control.

In addition to hands-on involvement with method trouble shooting, the incumbent will be involved with the evaluation of new technologies related to rapid microbiological methods, developing and executing validation studies related to rapid microbiology methods, and providing technical expertise to the manufacturing sites in relation to the microbiological/endotoxin methods.

The incumbent will require to work in laboratory to support validation studies associated with rapid microbiology methods (time spent may vary depending on projects).

Experience in pharmaceutical/biotechnology microbiology and manufacturing are preferred.

This individual would be a part of a team that would support various microbiology methods in various stages of the product life cycle.

This team would support programs/methods at locations throughout the company.

The Scientist collaborates with representatives from key functions within Process Development, Manufacturing and Quality.

BASIC QUALIFICATIONS: Doctorate degree OR Master’s degree and 4 years of Scientific experience OR Bachelor’s degree and 6 years of Scientific experience PREFERRED QUALIFICATIONS: Excellent written and oral communication skills for the timely documentation, presentation and discussion of scientific results in a fast-paced, multi-disciplinary, team-based environment.

Advanced ability to critically analyze and interrogate various analytical data sets to drive and influence the investigational process Advanced root cause analysis capabilities including leading advanced and complex events Advanced ability to propose and lead new scientific imperatives/initiatives Expert in an investigational laboratory setting within a pharmaceutical or biotechnology company Expert understanding and experience on analytical testing and sample handling Advanced understanding and hands-on experience in various analytical platform such as compendial microbial methods, rapid methods for microbial detection/identification and advanced technologies for detection of bacteria Advanced experience in working closely with scientific and manufacturing disciplines across process development, clinical, and commercial operations Familiarity with cGMP regulations, FDA and EU regulations and guidelines Experience designing and running process development microbiology laboratory Global regulatory and pharmacopeia compliance experience related to microbiological methods Prior experience in Microbiological Quality at both the technical and management levels providing support for microbiological methods