Scientist

Job Summary

The Scientist will perform the services to support sterile drug product manufacturing related activities as needed and directed to support sterile drug product manufacturing clinical deliverables.

Key Responsibilities

• Perform drug product manufacturing operations in a GMP environment in accordance with client procedures and training
• Draft and update batch records and associated documentation in compliance with cGMP regulations, Standard Operating Procedures (SOPs), and client standards of documentation
• Apply awareness of GMP principles and documentation practices
• Support and contribute to work area safety and compliance with client safety codes and regulations
• Communicate the status of assigned work and compliance systems to client stakeholders as appropriate
• Contribute to continuous improvement initiatives, administrative tasks, and optimization of current manufacturing and documentation practices within Sterile Operations

Education & Experience

Bachelor's degree in lab sciences such as Chemistry, Biochemistry, Biology, Engineering or similar and previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2-4 years) OR Masters degree and previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 1+ years). In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient.

Knowledge, Skills, and Abilities

• Previous work experience in a GMP environment
• Experience with steriles, parenteral products or similar
• Anti-body drug conjugate (ADC) experience
• Experience within an aseptic manufacturing environment
• Good documentation practices (GDP)

Working Environment

• Able to communicate, receive, and understand information and ideas with diverse groups of people
• Able to work upright and stationary and/or standing for typical working hours
• Able to lift and move objects up to 25 pounds
• Able to work in non-traditional work environments, ability to work in classified space with specified gowning
• Able to use and learn standard office equipment and technology with proficiency
• May have exposure to potentially hazardous elements, including infectious agents
• Able to perform successfully under pressure while prioritizing and handling multiple projects or activities