Scientist - Parenteral Packaging - Container Closu

Position Details:

Industry:

Pharmaceutical/Biotechnology Job Title:

Scientist I - Parenteral Packaging & Container Closure Systems (CCS)

Duration:

24

Months Contract Location:

Irvine, CA 92612

Shift:

Monday-Friday | 8 Hours per Day |

Standard Business Hours Number of Positions Needed:

1 Pay rate range : $34.00 to $39.00 per hour

Job Summary:

Scientist I within Global Material and Parenteral Packaging group supports manufacturing, process validation, regulatory submission, and continuous improvement for late-stage and commercial manufacturing of biological products. Responsible for design, evaluation and implementation of Container Closure System (CCS) development for early- and late-stage parenteral products.

Key Responsibilities:

Planning, preparation, execution and evaluation of experiments for development of container closure systems for new parenteral drug products. Evaluation and implementation of testing methods for CCS with focus on continuous improvement and adherence to regulatory requirements. Responsibility for assigned laboratory equipment including maintenance, documentation, and user training. Authoring comprehensive, scientifically sound reports for authority submissions. Collaboration with third party labs and/or manufacturing sites. Coordination of suppliers for materials, equipment, and services. Documentation of all work according to applicable GSP or GMP and internal procedural requirements. Supporting continuous landscaping programs for innovative CCS techniques. Presentation of project data and SME topics in internal global teams. Interacting professionally and effectively with peers and management.

Required Skills & Qualifications:

Bachelor's Degree:

chemistry/analytical science, material science or chemical engineering. 1-2 years industry hands-on experience. Evaluation and implementation of testing methods. Authoring comprehensive, scientifically sound reports. Problem solving. Good technical and scientific understanding of parenteral drug product development and regulatory guidelines. Ability to develop comprehensive test plans and evaluate design concepts. Ability to identify and communicate risks. Understanding of scientific literature and application of theoretical frameworks. Detail oriented with consistent results delivery. Working knowledge of regulatory requirements for parenteral pharmaceutical and biopharmaceutical products is desired. Scientific expertise in statistical data analysis is a plus. Experience working with cross functional teams (R D, Science & Technology, Operations, Quality, Regulatory). Excellent oral communication and technical writing skills.

Benefits:

The Company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, 401(k) retirement plan, life insurance, long-term disability insurance, short-term disability insurance, paid parking/public transportation, (paid time , paid sick and safe time , hours of paid vacation time, weeks of paid parental leave, paid holidays annually - These all are subject to applicable eligibility).