Job Description
Objective
Perspective Therapeutics is seeking an Analytical Chemist that will play a pivotal role in ensuring the quality and safety of our radiopharmaceutical products. You will collaborate closely with cross-functional teams including CMC, Research & Development, Quality Assurance, and Regulatory Affairs to support the development, validation, and execution of analytical methods critical to the manufacturing and release of our radiopharmaceutical products. Essential Functions
- Method Development and Validation: Design, develop, optimize, and validate analytical methods for drug substance and drug product testing, ensuring methods are robust, reproducible, and compliant with regulatory requirements (e.g., FDA, ICH).
- Instrumentation: Operate and maintain sophisticated analytical instruments such as HPLC, GC, iTLC, UV-Vis, and others as necessary for routine testing and method development.
- Quality Control: Perform routine and non-routine analysis of raw materials, intermediates, and finished products to support manufacturing operations, ensuring compliance with specifications and regulatory standards.
- Data Analysis and Reporting: Analyze experimental data, interpret results, and prepare comprehensive reports for method validations, stability studies, and investigations. Maintain accurate records of all analyses and findings in accordance with GMP/GLP.
- Troubleshooting and Problem-Solving: Identify and resolve technical issues related to analytical methods, instrumentation, or sample analysis in a timely manner to minimize impact on production schedules.
- Regulatory Compliance: Stay abreast of regulatory guidelines and industry trends related to analytical testing and method validation. Ensure all work is conducted in compliance with cGMP, SOPs, and other relevant regulations.
- Collaboration: Work closely with cross-functional teams including R&D, QA/QC, and Regulatory Affairs to support product development, tech transfer activities, and regulatory submissions.
- Continuous Improvement: Participate in continuous improvement initiatives to enhance laboratory operations, streamline processes, and implement best practices in analytical testing and method validation.
Qualifications
- Proficiency in analytical techniques such as HPLC, GC, spectroscopy, etc.
- Strong understanding of regulatory requirements (FDA, ICH) governing analytical method validation and cGMP/GLP practices.
- Excellent problem-solving skills and ability to troubleshoot analytical issues.
- Effective communication skills and ability to work collaboratively in a team environment.
Preferred Qualifications:
- Prior experience with radiopharmaceuticals or radioactive materials
- Experience with method development, method transfer, and analytical troubleshooting in a pharmaceutical setting.
- Experience with regulatory submissions (IND, NDA, etc.) and audits
Education / Experience
- Master's or PhD degree in Analytical Chemistry, Pharmaceutical Sciences, or a related field.
2 years of experience in pharmaceutical analytical development or quality control, preferably within a CMC environment.
Knowledge / Skill / Ability
The ideal candidate for the Analytical chemist position will possess a comprehensive understanding of analytical chemistry principles including spectroscopy and chromatography with extensive experience in method development and validation tailored to pharmaceutical applications. They will be well-versed in pharmaceutical regulations such as Good Laboratory Practice (GLP) and Good Manufacturing Practice (GMP), and have a strong background in the chemistry of pharmaceuticals, including organic, inorganic, and physical chemistry. Technical proficiency with analytical instruments, including HPLC, GC, radiation detectors, and UV-Vis spectrophotometers, is essential, alongside a solid grasp of data analysis and statistical methods for interpreting analytical results.
The successful candidate will demonstrate exceptional skills in developing, optimizing, and validating analytical methods, ensuring compliance with regulatory guidelines and industry standards. They will possess the ability to prepare detailed validation reports, troubleshoot technical issues, and maintain high levels of accuracy and attention to detail in all aspects of their work. Strong problem-solving abilities, adaptability to new technologies, and the capability to manage multiple projects concurrently while coordinating with cross-functional teams are crucial. Effective communication skills, both written and verbal, will enable them to present findings clearly, prepare comprehensive documentation, and collaborate effectively with stakeholders. Additionally, critical thinking skills will be vital for assessing experimental results, identifying trends, and making informed, data-driven decisions.
Work Environment The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Must be willing to work in a facility producing radioactive materials and requiring all employees to participate in safety programs designed to minimize potential and/or actual exposure levels.
- Must be able to work outside of regular work hours, including off shift, weekend, and holiday work as business needs require.
- May be required to sit or stand for long periods of 8+ hours a day while performing duties.
- Occasional kneeling, crouching, twisting the upper body, bending, stooping, pushing, pulling, or reaching may be required.
- 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 radioactive, corrosive, flammable and toxic material, dust, dirt, odors, and irritants.
- Must be willing to wear a variety of Personal Protective Equipment (PPE), including eye and hearing protection, as needed.
- Willingness to complete safety training within allotted timeframes, and work in a team-based environment.
Job Tags
Holiday work, Full time, Outdoor, Shift work,