Careers

 

 

 

CHEMIST – Analytical/Senior Analytical

Zevacor Molecular has a unique opportunity for an experienced Analytical Chemist at our

Noblesville, Indiana facility. You will lead in the method development, implementation and

validation of Quality Control (QC) analytical methods for new and existing radiometals, radio-pharmaceuticals, and isotope production, in compliance with all regulatory requirements (cGMP).

Duties & Responsibilities Include:

  • ICP-MS and ICP-OES.
  • Develops methods for the analysis of elemental species in radiopharmaceuticals.
  • Method validation per quality/regulatory requirements.
  • Implements methods for production according to cGMP regulatory requirements.
  • Writes SOPs (Standard Operating Procedures) for the methods.
  • Reviews existing SOPs, making recommendations for changes and modifications based on regulatory requirements and/or scientific rationales.
  • Trains and/or assists with the training of personnel in various analytical techniques.
  • Performs routine maintenance on instruments.
  • Conducts QC analytical tests for production according to cGMP regulatory requirements.
  • Samples, identifies, tests, labels/documents, preserves laboratory samples and associated electronically stored data.
  • Performs release testing in accordance with SOPs.
  • Maintains training requirements for entering restricted areas.
  • Maintains a clean and safe working environment and performs radiation safety duties in compliance with regulations.
  • Produces accurate production records and test/validation results.
  • Writes related reports, presentations and other documentation.
  • Records all activities in laboratory notebooks, batch documents, and related computer systems.
  • Performs other duties as assigned.

QUALIFICATIONS:

Education:

  • Requires a Bachelors’ Degree in Chemistry, Biochemistry or a related field. A Masters’ Degree in Chemistry, Biochemistry or a related field is highly preferred.

 Job Knowledge, Skills & Experience:

  • Proficiency in ICP-MS and/or ICP-OES with solid working knowledge in method development, validation, qualification, troubleshooting and maintenance of analytical equipment.
  • Prior work experience as an Analytical Chemist.
  • Prior experience in a GMP manufacturing environment.
  • Ability to read, write and interpret technical documents including safety rules, operating and maintenance instructions and procedure manuals.
  • Excellent communication, analytical, problem solving, presentation and computer/pc skills (including proficiency in Microsoft Office Suite and other related software.)
  • Knowledge of cGMP requirements, aseptic process (cleanroom environment) and equipment qualifications.
  • The ability to instruct, train and mentor beginners in analytical techniques.
  • Occasional lifting and carrying of light to moderate loads of up to 55 pounds.

 

We offer competitive compensation & benefits.

For immediate consideration submit your resume to: dessag@zevacor.com


HEAD OF RADIOCHEMISTRY

Zevacor Molecular has an outstanding opportunity for an experienced Radiochemist to head up our Chemistry Unit at our Noblesville, Indiana facility. As the Head of Radiochemistry you will lead in the management, development, implementation, validation for new radiopharmaceuticals, radiochemicals and isotope production. The position will also be the lead Radiochemist and will contribute to the ongoing process improvement of existing radiochemical processes.

Duties & Responsibilities Include:

  • Leads the Chemistry Unit on the industrialization of new synthesis processes.
  • Responsible for the ongoing training and development of the team.
  • Coordinates and manages the team’s activities per objectives.
  • Contributes to the qualification/validation campaign for new radiopharmaceutical implementations in accordance with GMP standards.
  • Collaborates with the Engineering Team to design, develop and test production equipment for the radiochemistry process.
  • Oversees and supports the ongoing production of isotopes and/or radiopharmaceuticals.
  • Oversees the successful transfer and implementation of technical transfer experiments.
  • Works with appropriate personnel to install, qualify and maintain new equipment on-site.
  • Oversees the improvement of current cGMP and non-GMP processes.
  • Ensures the Chemistry Team follows all SOP guidelines for QC release testing of radiopharmaceutical product, raw material, finished and semi-finished product, environment and facilities.
  • Reviews technical documents, procedures and processes, making recommendations for improvements, modifications, updates and changes.
  • Ensures the Chemistry Team maintains a clean and safe work environment, performing radiation safety duties in compliance with safety and pharmaceutical regulations.
  • Maintains accurate production and test/validation results.
  • Participates in the development and writing of SOP’s for the production process.
  • Performs other duties as assigned.

QUALIFICATIONS:

Education:

  • Requires a minimum of a Masters’ Degree in Chemistry, Biochemistry or a related field.
  • A PhD in Chemistry, Biochemistry or a related field is highly preferred.

 Job Knowledge, Skills & Experience:

  • Proficiency with ICP-MS and ICP-OES with solid working knowledge in method development, validation, qualification, troubleshooting and maintenance of analytical equipment.
  • 5 + years of progressive experience as a Radiochemist in radiopharmaceutical synthesis and/or isotope production, development and labeling techniques.
  • Expertise in analytical methods, equipment (ICP-MS, ICP-OES, GC, TLC, radiometric measurements …)
  • Expertise in laboratory procedures and radiochemistry techniques (separation techniques – SPE).
  • Prior experience in a GMP manufacturing environment and working with the FDA. Familiarity with FDA cGMP regulations.
  • Ability to read, write and interpret technical documents including safety rules, operating and maintenance instructions and procedure manuals.

Other Requirements:

  • Experience with cyclotron solid targets, process, dissolution and separation of radioisotopes.
  • Experience with radiation protection and safe handling of radioactive materials.
  • Excellent communication, analytical, problem solving, presentation and computer/pc skills (including proficiency in Microsoft Office 365 and other related software.)

We offer competitive compensation & benefits. Come be a part of an exciting team!

For immediate consideration submit your resume to: dessag@zevacor.com

Zevacor Molecular is an EEO/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identify, national origin, disability or protected veteran status.

 

SENIOR CYCLOTRON ENGINEER       

Zevacor Molecular is in the forefront of radioisotope research, development, manufacturing and production. We have an exciting opportunity for an experienced Cyclotron Engineer to work on the 70 MeV commercial Cyclotron at our headquarters in Noblesville, IN.

As a Senior Cyclotron Engineer you will be responsible for the operation of the leading-edge commercial particle accelerator (cyclotron) for the production of radiopharmaceutical products, with the focus on maintenance, repair and project work. You will also supervise and train other Cyclotron Engineers and Operators.

Responsibilities include:

  • Ensure the cyclotron is operating in accordance with proper operating procedures.
  • Oversee the Cyclotron Engineers and Cyclotron Operators in the daily operations of the Cyclotron including scheduling, maintenance, troubleshooting, repairs and related work.
  • Provide technical training and support to the Engineers and Operators.
  • Perform routine, non-routine, schedules and emergency maintenance on the cyclotron.
  • Prepare and complete documentation related to cyclotron operations,
  • Plan and perform maintenance activities.
  • Perform target system maintenance.
  • Design and build parts for the cyclotron to improve uptime and reliability.
  • Prepare and monitor trend analysis and tracking of cyclotron performance data.
  • Prepare and submit capital equipment requests.
  • Provide cyclotron operation coverage in emergency situations.
  • Troubleshoot problems including those of a complex nature.
  • Ensure compliance with all policies, procedures and regulatory requirements.
  • Performs other duties as assigned.

Education & Experience

  • Requires an Associates’ Degree in Electronics, Mechanical Engineering, Biomedical Engineering or a related field, along with a minimum of 8 years of cyclotron operations experience. A BS in Physics, Engineering or other science discipline is preferred, along with 5 years of cyclotron experience in the production of radiopharmaceutical products.
  • Equivalent Military Experience may also be considered..

 Knowledge, Skills & Experience

  • Detailed oriented, accountable, able to work in a team environment with minimum supervision
  • Ability to define problems, collect data, establish facts and draw valid conclusions.
  • Able to troubleshoot electronics to the component level.
  • Able to read and interpret mechanical and electrical drawings, along with understanding technical and complex manuals.
  • Proficiency with mechanical, hand and power tools used in maintenance, along with electronic testing equipment. Able to use radiation field survey meters.
  • Working knowledge of electrical, electronic, pneumatic and plumbing systems, along with electronic testing equipment including: oscilloscope, DVM and network analyzer.
  • Requires excellent math, communication, comprehension, organization, problem solving, analytical and computer/pc skills including current experience with Microsoft Office 365.
  • Working Conditions
    • Must be able to work shifts, weekends and holidays.
    • Occupational exposure to ionizing radiation.
    • Must be able to: climb ladders and stairs, work in protective clothing with respirators, operate in confined spaces (i.e. inside or underneath the cyclotron) and lift a minimum of 50 pounds.

    We offer competitive compensation & benefits.

    For immediate consideration submit your resume to: dessag@zevacor.com

 

CYCLOTRON OPERATOR         

Zevacor Molecular is in the forefront of radioisotope research, development, manufacturing and production. We have an exciting opportunity for a Cyclotron Operator to work on the leading edge in cyclotrons at our headquarters in Noblesville, IN.

The Cyclotron Operator is accountable for the operation of the cyclotron, a nuclear particle accelerator. This individual should be capable of independent decision-making abilities for most cyclotron situations, and will be called upon to trouble shoot related manufacturing concerns.

Responsibilities include:

  • Operating the cyclotron in accordance with established and approved operating procedures
  • Assist Engineers in performing routine, scheduled and emergency maintenance on the cyclotron.
  • Complete documentation related to cyclotron operations
  • Provide information to management regarding equipment operation and status.
  • Provide basic QC support for isotope manufacturing.
  • Perform radiation safety duties to ensure compliance with all government and regulatory regulations, procedures and requirements.
  • Performs other duties as assigned.

Education & Experience

  • While a BS in Physics, Engineering or other science discipline is preferred, an Associate’s Degree in Electronics or other technical or scientific discipline may be considered with 1 – 2 years of prior related experience.
  • Equivalent Military Experience may also be accepted.

 Knowledge, Skills & Experience

  • Working knowledge of project management techniques
  • Detailed oriented, accountable, able to work in a team environment with minimum supervision
  • Ability to define problems, collect data, establish facts and draw valid conclusions
  • Working knowledge of mechanical tools used in maintenance
  • Requires excellent math, communication, comprehension, organization, problem solving, analytical and computer/pc skills including current experience with Microsoft Office.
  • Requires the ability to analyze and interpret technical procedures and manuals.
  • Knowledge of basic cGMP practices and procedures are helpful

Working Conditions

  • Must be able to work shifts, weekends and holidays.
  • Occupational exposure to ionizing radiation.
  • Must be able to: climb ladders and stairs, work in protective clothing with respirators, operate in confined spaces (i.e. inside or underneath the cyclotron) and lift a minimum of 50 pounds.

We offer competitive compensation & benefits.

For immediate consideration submit your resume to: dessag@zevacor.com

 

COMPLIANCE SPECIALIST

Zevacor Molecular has a great opportunity for an experienced cGMP Compliance Specialist to join our Compliance Team at our Noblesville, Indiana headquarters. As a Compliance Specialist you will be responsible for implementing and supporting the Quality Management System (QMS) in accordance with Company policies, procedures and applicable government regulations. The position will be responsible for providing confidence to management that product quality requirements will and have been met.

Duties & Responsibilities Include:

  • Create, maintain and review cGMP Quality policies and procedures.
  • Initiate, review, approve and monitor Quality Events.
  • Participates in regulatory authority and client audits.
  • Conducts incoming material disposition.
  • Reviews and assesses in-house solution preparation and external material testing.
  • Review and compile KPP and Quality metrics
  • Analyze data to identify areas for improvement in the quality system.
  • Review, assess and release quality control tests and/or production batch records.
  • Performs or assists in the material release for production.
  • Assist the Lab Coordinator as needed with qualification activities.
  • Performs or assists with accountability reviews
  • Performs other duties as assigned.

QUALIFICATIONS:

Education:

  • Bachelor’s Degree in Chemistry, or other science or related discipline. A minimum of

5 prior years of equivalent and related experience may be considered in lieu of a degree.

 Job Knowledge, Skills & Experience:

  • Requires a minimum of 3 years of responsible Quality experience in the cGMP

pharmaceutical industry, preferably in radiopharmaceuticals or PET drug manufacturing.

  • Knowledge of tools, concepts and methodologies of cGMP Quality.
  • Quality Event authorship or review experience and lot release support.

Other Requirements:

  • Excellent communication, organization, analytical, presentation and computer/pc skills

to include proficiency with Microsoft Office 365. Able to communicate complex technical issues

to all levels of personnel, customers and management.

  • Exceptional attention to detail.

We offer competitive compensation & benefits.

For immediate consideration submit your resume to: dessag@zevacor.com