Intern, R&D - Operations

American Regent, Inc.•New Albany, OH

1d•Onsite

About The Position

Nature and Scope Assist in the providing hands-on support to Analytical, Formulation and Tech Services R&D Scientists in development, scale-up and characterization of pharmaceutical drug products. Assist in identifying vendors with niche capabilities and maintain vendor-list. Maintain inventory of materials for scale-up batches. Essential Duties and Responsibilities Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time. Perform routine laboratory experiments to study parenteral formulation, material compatibility and manufacturing process. Analyze different critical quality attributes like particle size, viscosity and dissolution of various R&D projects. Perform risk assessment and mitigation aspects of various R&D projects. Record and report all lab data as per approved procedures and regulatory requirements. Provide hands-on support to R&D Chemists, Associate Scientists and Scientists on R&D activities in the laboratories and data compilation. Ensure that good housekeeping is maintained in the R&D areas. Ensures all work is performed and documented in accordance with existing Company policies and procedures, as well as cGMP and health and safety requirements. Research vendors or research labs offering unique capabilities to progress complex product development. Maintain inventory of materials ordered and received for production of scale-up batches. Compile and maintain inventory of external vendors. Perform any other tasks/duties as assigned by management.

Requirements

Rising Junior or Senior pursuing a Bachelor’s degree in Pharmaceutical Science, Chemistry, Chemical Engineering or equivalent required.
Completed at least a two semester course work with laboratory in General Chemistry and Organic Chemistry.
Attention to detail and able to follow instructions and operating procedures.
Excellent organizational, interpersonal and communication skills required.
Physically able to wear laboratory protective gowning and equipment, including but not limited to gowning, goggles, face shields, respirators, and protective gloves.
Employees must maintain a clean-shaven appearance each working shift to wear tight-fitting respirators properly.
Specific vision requirements include 20/20 near vision (can be corrected with eyeglasses or contacts) and color vision.

Nice To Haves

Proficiency in Microsoft Office Word and Excel is highly desirable.

Responsibilities

Perform routine laboratory experiments to study parenteral formulation, material compatibility and manufacturing process.
Analyze different critical quality attributes like particle size, viscosity and dissolution of various R&D projects.
Perform risk assessment and mitigation aspects of various R&D projects.
Record and report all lab data as per approved procedures and regulatory requirements.
Provide hands-on support to R&D Chemists, Associate Scientists and Scientists on R&D activities in the laboratories and data compilation.
Ensure that good housekeeping is maintained in the R&D areas.
Ensures all work is performed and documented in accordance with existing Company policies and procedures, as well as cGMP and health and safety requirements.
Research vendors or research labs offering unique capabilities to progress complex product development.
Maintain inventory of materials ordered and received for production of scale-up batches.
Compile and maintain inventory of external vendors.
Perform any other tasks/duties as assigned by management.