Scientist

Planet Pharma; Thousand Oaks (CA); Vor Ort; USD 40.000 - 54.000; Vollzeit

Zusammenfassung

Planet Pharma in Thousand Oaks, CA is seeking a Scientist to support microbiology related methods such as endotoxin, bioburden, sterility and other compendial microbial controls. This role involves hands-on laboratory work, troubleshooting, and evaluating new technologies in rapid microbiology, including feasibility and/or validation studies.

The successful candidate will work in the lab on feasibility/validation projects, with experience in pharmaceutical/biotechnology microbiology and

Qualifikationen

• Doctorate Degree OR Masters Degree and 4 years of Scientific Experience OR Bachelors degree and 6 years of Scientific experience
• Experience in pharmaceutical/biotechnology microbiology and manufacturing preferred.
• Strong written and oral communication skills for fast-paced, cross-functional teamwork.

Aufgaben

• Support feasibility and validation studies for microbiology methods.
• Hands-on lab work including troubleshooting and method development.
• Collaborate with Process Development, Manufacturing, and Quality across programs.

Kenntnisse

Microbiology methods

Rapid microbial methods

cGMP familiarity

Analytical data interpretation

Ausbildung

Doctorate degree or Masters with 4 years or Bachelors with 6 years experience in Science

Jobbeschreibung

Target PR Range: 29-39/hr DOE

Job Description:
Scientist will support microbiology related methods such as, endotoxin, bioburden, sterility and other compendial methods associated with microbial control. Hands on laboratory work include method troubleshooting, and involvement in evaluating new technologies related to rapid microbiology methods, including developing and executing feasibility and/or validation studies.
The candidate will require to work in the laboratory to support feasibility and/or validation studies (time spent in lab varies depending on projects). Experience in pharmaceutical/biotechnology microbiology and manufacturing are preferred.
The candidate would be a part of a team that supports various microbiology methods in various stages of the product life cycle. This team supports 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 Masters Degree and 4 years of Scientific Experience OR Bachelors degree and 6 years of Scientific experience

Preferred Qualifications

• Prior experience in Microbiological Quality at the technical level, including experience with sterile filtration validations
• 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
• 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 (e.g. complex dilution schemes) 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
• 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