Job Description

• Reporting to the Research Advisor, the Associate Senior Scientist will provide and utilize technical direction and expertise throughout the entire drug development process with focus on pre-formulation studies, analytical development and optimization studies, and informal and formal stability studies.
• The Associate Senior Scientist Research and Development will have a working knowledge of various aspects of implementing the drug development process in a regulated environment, including topics such as Quality by Design (QbD), Design of Experiment (DOE), and compliance with all regulatory guidelines.
• The Associate Senior Scientist Research and Development will be responsible for execution of reports, protocols, providing analytical support for formulation development, investigations and laboratory work and providing technical expertise and support on multiple projects in the portfolio.
  

Duties & Responsibilities:

• Plan, coordinate, and drive the development and evaluation of new drug products, including pre-formulation excipient solubility and compatibility studies, formulation development, analytical method support including method development and validation, scale-up manufacturing and testing
  
• Provide technical leadership and mentoring to individuals, functional area and overall organization as required
  
• Ensure appropriate technical review and oversight for portfolio projects/programs as required
  
• Effectively communicate on a timely basis with management, other laboratories within as well as customers to coordinate method transfers, validations, and development
  
• Provide analytical development guidance and mentoring to laboratory staff
  
• Operate under and maintain GMP/GLP conditions
  
• Represent functional area and projects at local, technical, governance, executive and customer meetings as required
  
• Understand and support strategies, initiatives, expectations, processes and portfolio commitments
  
• Must be able to work extended hours, weekends as needed, especially when problems occur or when deadlines must be met
  

Perform other duties as required

Qualifications:

Education:

• Bachelor??s Degree in Science or related field
  
• Masters Degree preferred
  

Experience:

• Minimum 3-5 years of experience in a formulations role in a lab setting
  
• Experience working in a manufacturing, pharmaceutical and/or GMP facility
  

Skills Required

• Familiarity with typical formulation and analytical approaches for pharmaceutical development
  
• Hands on experience with analytical laboratory equipment such as HPLC and GC
  
• Excellent time management and organizational skills
  
• Requires experience in troubleshooting and problem solving
  
• Skilled in the use of Microsoft Office
  
• Strong interpersonal skills are essential in dealing with people at all levels and in a variety of functional areas; able to influence and motivate others to quickly achieve results