Quality Control Chemist

Isotopia Molecular Imaging ltd; Westfield (IN); On-site; USD 50,000 - 80,000; Full time

Job summary

A leading biotech company situated in Indiana seeks a Quality Control Chemist to ensure safe and efficient production of its radiopharmaceutical products. The role demands rigorous testing and validation, as well as collaboration with production and quality assurance departments to meet regulatory standards while contributing to patient safety.

Benefits

401K Retirement Program with Company Contribution

Health Insurance for Individual and Dependents

Dental Insurance

Vision Insurance

Life Insurance

Short-term Disability Insurance

Long-term Disability Insurance

Qualifications

• Prior experience in pharmaceutical quality control preferred.
• Strong understanding of cGMP requirements is needed.
• Ability to handle time-sensitive processes effectively.

Responsibilities

• Perform routine testing of materials and radiopharmaceutical products.
• Ensure compliance with cGMP for data recording and inspections.
• Coordinate with production for timely testing and release.

Skills

Detail-oriented

Effective communication

Teamwork abilities

Organizational skills

Education

Bachelor's degree in Chemistry

Tools

ICP-MS

ICP-OES

radio-TLC

Job description

Isotopia is a global biotech company manufacturing key ingredients for pharmaceutical cancer drugs. At our US headquarters in Indianapolis, we will be next door to our key customers, delivering our products just in time, each day, every day. We are seeking a highly motivated and detail-oriented Quality Control Chemist to join our dynamic team. You will play a crucial role in ensuring the safe and efficient production of our products. You will be part of a family, a team, dedicated to our mission to deliver on our covenant with our customers.

Requirements

Responsibilities:

• Perform routine testing of raw materials, in process materials, and radiopharmaceutical products
• Execute method validation protocols and generate reports
• Execute stability protocols and generate reports
• Assist with method development and implementation
• Comply with cGMP requirements for recording of data
• Perform routine inspections of laboratory notebooks and of the laboratory environment in accordance with written inspection procedures
• Perform routine wipe and survey testing for radiation protection
• Maintain inventory of materials required for analytical testing
• Assist with analytical equipment IQ/OQ/PQ protocol execution
• Coordinate with third party equipment vendors to schedule routine equipment requalification
• Assist with drafting analytical equipment risk assessments
• Assist with trending of data and report drafting as needed
• Assist with environmental monitoring program as needed
• Coordinate with production personnel to ensure timely testing and release of intermediate materials and final product
• Coordinate sampling plans and shipment of samples to third party labs for any necessary third-party testing
• Assist with technical review of routine test documents, method validation protocols / reports, and method development protocols / reports
• Perform any other tasks related to analytical testing as necessary
  
  
  

Education and Skills:

• Bachelor's degree in Chemistry is strongly preferred
• Previous experience with compendial USP test methods, ICP-MS / ICP-OES, radio-TLC, and/or direct inoculation sterility testing is strongly preferred
• Previous experience in pharmaceutical / radiopharmaceutical quality control is preferred
• Strong understanding of cGMP requirements and radiation safety practices is preferred
• Detail-oriented mindset with excellent organizational and record-keeping skills
• Effective communication and teamwork abilities, with a focus on collaborative problem-solving
• Ability to work in a regulated and fast-paced environment while maintaining a high level of accuracy
• Flexibility to work in shifts and handle time-sensitive processes
• Strong commitment to safety, ethical conduct, and compliance with regulations
• Physical ability to stand for extended periods, lift moderately heavy objects up to 50 pounds, and to handle frequent stooping and crouching, and wear appropriate PPE
• Manual dexterity for manipulating small items
  
  
  

Benefits

• 401K Retirement Program with 3% of Salary Company Contribution
• Individual and Dependent Health Insurance
• Dental Insurance
• Vision Insurance
• Life Insurance
• Short-term Disability Insurance
• Long-term Disability Insurance