Senior Development Engineer

The Senior Development Engineer position (International) will work with and in multiple cross-functional groups and report to Sr. Dir. Of Downstream Chemistry. This role will support products currently in North America that will be transferred to Asia and Europe. The successful candidate will serve as the technical point of contact between the Operations International Business Unit and North American Business. On a regular basis, this role will interact with Upstream Chemistry, Downstream Chemistry, Clinical, Engineering, Operations, Supply Chain, Regulatory, and Quality Assurance. Their customer will be the Global Technical Operations Group.

• Organize and understand the data and documentation from existing development and commercial archives in North America.
• Author a comprehensive process transfer plan that will be used as the roadmap for successful transfer.
• Utilize existing relationships in R&D and Operations to help find, analyze, compile, and send the correct data and documents to the right location per the approved transfer plan.
• Work with external vendors to decide any additional pre-clinical testing that needs to be conducted and obtain those samples from the group within Operations or R&D.
• Lead and assist with troubleshooting technical challenges as they arise - this may require international travel.
• Maintain a detailed, R&D project schedule and list of tasks that support the project objectives.
• Be able to manage priorities of oneself and others to get actions completed per the approved project schedule.
• 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.).

• Bachelor Degree in Chemistry, Engineering, Biochemistry, Manufacturing, Biology, Life Sciences, or related field required.
• Five or more years of pharmaceutical industry experience required (Radiopharmaceutical experience highly preferred).
• Pharmaceutical industry experience with familiarity with cGMP, FDA, USP, NRC, and ICH guidelines.
• Existing knowledge of Cyprus and Kojak development and commercialization is a plus.
• Hands-on experience in manufacturing or laboratory settings preferred.
• Understanding of analytical methodology (e.g., HPLC, GC, UV/VIS, Gamma Spec) and review and understanding of analytical results.
• Strong organizational and people skills, including ability to work independently, and as the member of a cross-functional team.
• Behavioral requirements for success in this position include innovation management, drive for results, global business knowledge, and action oriented.
• Excellent written and verbal communication skills.
• Proven experience with Microsoft Project, Word, Excel, and Visio software.
• Experience with data analysis and reporting using Minitab statistical software.

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.