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.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.
 

 

QUALITY ENGINEER

Zevacor Molecular has a unique opportunity for an experienced Quality Engineer at our Noblesville, Indiana facility. You will be responsible for developing and implementing the Quality Management System (QMS) as related to the Cyclotron and Engineering functions. The position will also ensure that projects are managed according to priority, on-time and with the appropriate levels of control.

Duties & Responsibilities Include:

·  Create, maintain, and review PDLC (Product Development Life Cycle) Control System.

·  Implement and manage design control mechanism based on Solid Works functionality related documents such as SOPs, drawing templates, commissioning and validation plans

· Working with Manufacturing Operations, develop preventive maintenance schedules for major equipment.

·  Review changes of specifications and processes regarding engineering designs ensuring Quality standards are met.

·  Leads self-inspection program and/or will develop the program for Engineers to self-inspect.

·   Supports on-site audits by customers and/or regulatory agencies

·  Assists with and/or leads validation activities.

·  Reviews and approves Quality Event filings (i.e., CAPA, Change Control, Deviations and OOS)

·  Reviews and approves technical documents (i.e. protocols or IQOQ, URS, DIR…)

·  Leads parts and assembly inspection programs.

·  Collaborates with Production, Development, IT, and Quality teams to prioritize tasks and  workflow of major projects.

·  Performs other duties as assigned.

QUALIFICATIONS:

Education:

·  Requires a Bachelor’s Degree in Chemical Engineering, Mechanical Engineering, or other related Engineering or Science discipline.

·  Related Certifications (PMP, Quality Engineer, Quality Improvement Associate, Six Sigma…)preferred.

 Job Knowledge, Skills & Experience:

·  Requires a minimum of 5 years of Quality Engineering experience in an equipment design and manufacturing environment, preferably in complex equipment development.

·  Good working knowledge of Solid Works especially design control functionality.

·  Requires a solid mechanical and/or electrical engineering background.

·  Experience in establishing and maintaining QMS and PDLC management systems.

·  Prior experience with ISO9001 or ISO13485.

·  Knowledge of tools, concepts and methodologies of quality engineering

·  Prior experience with SolidWorks or related engineering QMS

·  Excellent communication, organization, analytical, presentation and computer/pc skills to include proficiency with Microsoft Office. Able to communicate complex technical issues to all levels of Personnel, customers and management

· Exceptional attention to detail.

· Solid project management experience and skills.

Experience with risk management.

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.

 

 

 

 

 

 

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.