Senior Analytical Chemist

The Senior Analytical Chemist position will report into the R&D Upstream Chemistry Organization. The successful candidate will serve as a key functional core team member and will support or may serve in a lead role, and will be required to perform characterization, troubleshooting, and introduction of newer technologies utilizing multiple analytical techniques, including proficiency with some of the following instrumentation:

• HPLC/UPLC
• TLC/iTLC
• Dose Calibrator
• High-Purity Germanium (HPGe) Detectors
• Lighthouse Headspace
• Alpha & Gamma Spec
• UV Vis
• Infrared Spectroscopy
• ICP-OES/ICP-MS
• FTIR
• IC
• GC-FID/GC-MS
• LC-MS
• SEM

Work schedule: Monday - Friday 8am - 5pm

• Apply analytical techniques to support R&D projects, customer complaint investigations, and analytical support for the Quality & Regulatory organizations. Types of samples expected are liquids, gases, and solids of radioactive and non-radioactive materials
• Support and assist in technology transfer activities and provide oversight for method feasibility & implementation
• Perform analytical method development, qualification, validation & transfer, as well as compendium assessments and verifications
• Support new product development and life cycle management of existing products
• Oversee the support of R&D process development & engineering batches
• Utilize existing relationships in R&D, Operations, and Quality to resolve any OOS or OOT that may arise during analysis of raw materials and drug product batches
• Be able to maintain, troubleshoot, and repair GC (Headspace) and HPLC instruments
• Be able to manage priorities of oneself and others to ensure organizational goals are completed in a timely matter
• Maintain a project schedule and list of tasks consistent with the organization's priorities
• 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, Chemical Engineering, Biochemistry, Biology, Life Sciences, or related field required.
• 5 or more years of relevant experience required.
• Radiopharmaceutical experience and pharmaceutical development (small / large / biological) experience highly preferred.
• Pharmaceutical industry experience is highly preferred with a strong familiarity with cGMP, FDA, USP, NRC, and ICH guidelines.
• Behavioral requirements for success in this position include self-starter, strong work ethic, excellent written and verbal communication skills.
• The successful candidate must have the ability to successfully support and potentially manage multiple analytical projects and 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.
• Potential of 10% travel.