Perspective Therapeutics

Analytical Chemist

Coralville, IA
Full Time
Isotope Manufacturing
Experienced

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.
Share

Apply for this position

Required*
Apply with Indeed
We've received your resume. Click here to update it.
Attach resume or Paste resume
Attach resume as .pdf, .doc, .docx, .odt, .txt, or .rtf (limit 5MB) or Paste resume

Paste your resume here or Attach resume file

To comply with government Equal Employment Opportunity and/or Affirmative Action reporting regulations, we are requesting (but NOT requiring) that you enter this personal data. This information will not be used in connection with any employment decisions, and will be used solely as permitted by state and federal law. Your voluntary cooperation would be appreciated. Learn more.
Invitation for Job Applicants to Self-Identify as a U.S. Veteran
  • A “disabled veteran” is one of the following:
    • a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or
    • a person who was discharged or released from active duty because of a service-connected disability.
  • A “recently separated veteran” means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.
  • An “active duty wartime or campaign badge veteran” means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.
  • An “Armed forces service medal veteran” means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.
Veteran status


Voluntary Self-Identification of Disability
Voluntary Self-Identification of Disability Form CC-305
OMB Control Number 1250-0005
Expires 04/30/2026
Why are you being asked to complete this form?

We are a federal contractor or subcontractor. The law requires us to provide equal employment opportunity to qualified people with disabilities. We have a goal of having at least 7% of our workers as people with disabilities. The law says we must measure our progress towards this goal. To do this, we must ask applicants and employees if they have a disability or have ever had one. People can become disabled, so we need to ask this question at least every five years.

Completing this form is voluntary, and we hope that you will choose to do so. Your answer is confidential. No one who makes hiring decisions will see it. Your decision to complete the form and your answer will not harm you in any way. If you want to learn more about the law or this form, visit the U.S. Department of Labor’s Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp.

How do you know if you have a disability?

A disability is a condition that substantially limits one or more of your “major life activities.” If you have or have ever had such a condition, you are a person with a disability. Disabilities include, but are not limited to:

  • Alcohol or other substance use disorder (not currently using drugs illegally)
  • Autoimmune disorder, for example, lupus, fibromyalgia, rheumatoid arthritis, HIV/AIDS
  • Blind or low vision
  • Cancer (past or present)
  • Cardiovascular or heart disease
  • Celiac disease
  • Cerebral palsy
  • Deaf or serious difficulty hearing
  • Diabetes
  • Disfigurement, for example, disfigurement caused by burns, wounds, accidents, or congenital disorders
  • Epilepsy or other seizure disorder
  • Gastrointestinal disorders, for example, Crohn's Disease, irritable bowel syndrome
  • Intellectual or developmental disability
  • Mental health conditions, for example, depression, bipolar disorder, anxiety disorder, schizophrenia, PTSD
  • Missing limbs or partially missing limbs
  • Mobility impairment, benefiting from the use of a wheelchair, scooter, walker, leg brace(s) and/or other supports
  • Nervous system condition, for example, migraine headaches, Parkinson’s disease, multiple sclerosis (MS)
  • Neurodivergence, for example, attention-deficit/hyperactivity disorder (ADHD), autism spectrum disorder, dyslexia, dyspraxia, other learning disabilities
  • Partial or complete paralysis (any cause)
  • Pulmonary or respiratory conditions, for example, tuberculosis, asthma, emphysema
  • Short stature (dwarfism)
  • Traumatic brain injury
Please check one of the boxes below:

PUBLIC BURDEN STATEMENT: According to the Paperwork Reduction Act of 1995 no persons are required to respond to a collection of information unless such collection displays a valid OMB control number. This survey should take about 5 minutes to complete.

You must enter your name and date
Human Check*