Research Scientist

Summary of Position:

The Research Scientist performs activities supporting the laboratory function in executing daily operations of the Research and Development (R&D)Laboratoriesor the developing and validating the manufacturing processes necessary to support commercialization of pharmaceutical products.

Organization Structure:

The Research Scientist directly reports to a Director.

Responsibilities Include: 

1. Support Laboratory Functions:                                                                                      
   1. Laboratory housekeeping duties
   2. Maintain laboratory equipment
   3. Maintain adequate supplies
   4. Perform laboratory procedures in accordance with approved procedures/documents
   5. Operation of equipment in accordance with approved procedures/documents
2. Manufacturing Processes Development and Validation Support         
   1. Identify  key process parameters and their impact on product quality
   2. Develop solutions and action plans to address quality and production improvements         
   3. Develop and execute equipment installation and operational qualifications
   4. Develop and execute process validations
   5. Technical resource for the Operations Department                          
   6. Assist in initial room designs and equipment specifications
3. Administrative duties
   1. Prepare documents               
   2. Maintain laboratory records, files
   3. Use statistical methods to determine in-control/out of control processes
4. Training
   1. Develop training materials
   2. Train others

1. Leadership
   1. Routinely manage staff as determined by the Group Leader or Director.
   2. Interface with customers
   3. High level problem solving
   4. Ensure correct, up-to -date technical information is readily available and being used by the operating team
   5. Lead and execute design of experiments

Qualifications:

1. Entry level PhD in related field or equivalent  education and expertise (example BS with 10 years of pharmaceutical experience)
2. Strong oral and written communications skills
3. Proficient in computer use (Word, Excel, internet) with ability to learn new computer applications
4. Ability to follow standard operating procedures to perform work function
5. Strong clerical aptitude, sound judgment and operates with a sense of urgency in a fast paced environment
6. Strong interpersonal skills

GMP Decision Making Authority:

The Research Scientist has authority to perform work as assigned supporting the laboratory function or supporting development and validation of manufacturing processes. This includes following approved procedure and guidance received from supervisors.