Development Chemist

Summary of Position

The Development Chemist will report into the Senior Director of Upstream R&D. The successful candidate will serve as a key functional team member and will support development of new products through chemical synthesis, labeling, purification, etc.

Work Schedule : Monday - Friday 8 : 00am - 5 : 00pm. Hours can be adjusted

Essential Functions

• Support R&D initiatives and related project teams through development and implementation of robust drug product formulations and processes.
• Support lifecycle management of existing products.
• Design, synthesize, purify and characterize drug candidates based on a risk-based approach to drug development.
• Design and execute experiments to support process design, and to expand the development space for successful tech transfer of processes.
• Interpret simple to moderately complex chromatography spectra and other analytical data.
• Interface and collaborate with research and operation-focused functional teams including manufacturing and quality functions.
• Scientific writing including batch records, laboratory notebooks, summary reports, and other documents in support of CMC aspects for regulatory submissions.
• Performs other duties as assigned.
• Must maintain operational compliance with US and international regulatory agencies and guidelines (i.e. FDA, EU, HC, TGA, PIC / S, ISO, USP, NRC, cGMP, etc.).

Requirements

• Bachelor Degree in Chemistry, Chemical Engineering, Biochemistry, Biology, Life Sciences, or related field.
• Minimum of three years of relevant work experience required.
• Understanding of pharmaceutical drug development or process chemistry desired.
• Radiopharmaceutical experience preferred.
• Pharmaceutical industry experience is desired with a strong familiarity with cGMP, FDA, USP,NRC, and ICH guidelines.
• Effective communicator and collaborator, ability to work cross functionally within and outside the organization.
• Behavioral requirements for success in this position include : self-starter, strong work ethic, excellent written and verbal communication skills and willingness to learn new things.
• The successful candidate must have the ability to contribute to team based investigations.

Working Conditions :

• Willingness to work in plant producing radioactive materials and requiring all employees to participate in safety programs designed to minimize potential and / or actual exposure levels.
• Responsibilities include the ability to lift up to 70 pounds, kneeling, crouching, twisting the upper body, walking, bending, stooping, pushing, pulling, reaching, must be able to physically negotiate stairs and evacuation ladders with or without accommodation, wear and operate safety equipment, enter vessels, and inspect equipment.
• Material handling devices (e.g., hand truck, fork truck, and conveyors) are used when possible, however, use of proper lifting and movement techniques is necessary to prevent injury.
• Must be willing to wear a variety of Personal Protective Equipment (PPE) and hearing protection as needed.
• May be required to sit or stand for long periods of 8+ hours a day while performing duties.
• Must possess good hand-eye coordination; close attention to detail is required.
• Must be able to work indoors and outdoors with exposure to mechanical / moving parts, hazards including corrosive, flammable and toxic material, dust, dirt, odors, and irritants.
• Willingness to complete safety training within allotted timeframes, and work in a team-based environment.
• Must be able to work outside of regular work hours, including off shift, weekend, and holiday work as business needs require.
30+ days ago