Careers

 

 

Sr. ANALYTICAL CHEMIST

Zevacor Molecular has a unique opportunity for an experienced analytical chemist at our Noblesville, IN facility. As a Sr. Analytical Chemist you will lead in the development, implementation and validation of Quality Control (QC) analytical methods for new and existing radiometals, radiopharmaceuticals, and isotope production, in compliance with all regulatory requirements (cGMP).

Duties & Responsibilities Include:

  • ICP-MS and ICP-OES.
  • Develops methods for the analysis of 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.
  • May conduct environmental monitoring of the lab, environment and facilities.
  • Performs other duties as assigned.

POSITION QUALIFICATIONS:

 Job Knowledge, Skills & Experience:

  • A minimum of 7 years of experience in ICP-MS and ICP-OES with extensive knowledge in method development, validation, qualification, troubleshooting and maintenance of analytical equipment.
  • Prior experience in a GMP manufacturing environment.
  • Experience with GC.
  • Experience with Radiometric Detectors a plus but not required
  • Ability to read, write and interpret technical documents including safety rules, operating and maintenance instructions and procedure manuals.

Education:

  • Requires a minimum of a Master’s Degree in Chemistry or Bachelor’s Degree in Chemistry with 5 years of related experience in a Senior Analytical role.

Other Requirements:

  • 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

WORKING CONDITIONS

Environmental Factors

  • Occasional exposure to moderate environmental variations, above-normal noise levels, and/or unpleasant substances.
  • Occupational exposure to radiation.
  • Occupational exposure to laboratory chemicals.

 Physical Demands

The physical demands described are representative of those that must be met by an employee to successfully perform the essential functions of this job.

  • Light to moderate physical exertion, including occasional standing, bending, reaching and occasional lifting and carrying of light to moderate loads (of up to 55 pounds).

Come be a part of this exciting team!

We offer competitive compensation & benefits.

Must be authorized to work in the U.S.

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.

 

 

PRODUCTION/QC CHEMIST

Zevacor Molecular has an exciting opportunity for a Production/Quality Control (QC) Chemist at our Noblesville, IN facility. As part of the Production team, you will be responsible for process manufacturing of radiopharmaceutical products, preparation of production materials, supplies, general production equipment maintenance and quality control of products.

Duties and responsibilities include:

  • Performing chemistry manipulations in Production, QC and Development.
  • Production chemistry in manufacturing of radioisotopes.
  • ‘Analytical methods and procedures for the QC testing of GMP manufactured radiopharmaceutical products and substances.
  • Optimize and validate QC methods and procedures necessary for validating radiopharmaceutical products.
  • Carry put production responsibilities to meet manufacturing schedules.
  • Ensure regulatory compliance of production and QC protocols within the manufacturing operations.
  • Assist with the implementation of production in manufacturing.
  • Assist with creating SOP’s for use in Production and QC.
  • Complies, prepares and submits required reports on development projects.
  • May assist with the preparation of regulatory submissions including compiling CMC sections of related application.
  • Support and execute CPI – Continuous Process Improvement initiatives through implementation of Deviation Reporting, OOS and Root Cause Investigations, CAPA and Change Control.
  • Assist with general lab cleaning, supplies and maintenance.

Qualified applicants will have:

  • A Bachelor’s Degree in Chemistry, Biochemistry, Chemical Engineering or a related field. An Associates’ Degree in Chemistry or Chemical Engineering along with a minimum of 3 years of related experience in a pharmaceutical manufacturing environment with preference to Radiopharmaceuticals, may be considered.
  • Prior experience with HPLC, Gas Chromatography (GC) and other chemistry related equipment.
  • Excellent communication, analytical and technical writing skills.
  • The ability to handle responsibilities in a demanding manufacturing environment.

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

Must be authorized to work in the U.S.

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.

 

 

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 with focus on maintenance, repair and project work.  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
  • Perform routine, scheduled and emergency maintenance on the cyclotron.
  • Complete documentation related to cyclotron operations
  • Plan accelerator maintenance activities and dose management.
  • Perform target system preventative maintenance
  • Perform diagnosis and repair on the following related cyclotron operations equipment: electronics, electro-pneumatic systems, high vacuum systems, deionized chilled water systems, high voltage, target, and high power RF systems.
  • 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.
  • Perform trend analysis and tracking of cyclotron performance data, preparing related reports.
  • Performs other duties as assigned.

Education & Experience

  • Requires an Associate’s Degree in a Electronics or a related technical discipline, with 1-2 years of experience in the Electronics field.
  • BS in Physics or Nuclear, Mechanical, Bioengineering or other related Engineering disciplines is preferred.

 Knowledge, Skills & Experience

  • Working knowledge of digital and analog circuitry.
  • Ability to read and interpret mechanical and electrical drawing
  • Knowledge of basic electronic test equipment, multimeters, oscilloscope, and network analyzers.
  • Working knowledge of project management techniques
  • Apply mathematical operations to such tasks as frequency distributions, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory and factor analysis.
  • 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
  • Ability to trouble shoot electronics down to the component level – preferred
  • Understand detailed theory of operation for most accelerator systems – preferred
  • Working knowledge of mechanical tools used in maintenance – accelerator preferred
  • Experienced in diagnosis and repair of equipment failures – accelerator preferred
  • Prior knowledge of radiation field survey meters – preferred.
  • High voltage training – preferred
  • Prior experience working  with high voltage equipment
  • 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 – preferred

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

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.