Chemist, Radiochemical Manufacturer

COMPANY OVERVIEW

SpectronRx is a rapidly growing Contract Development and Manufacturing Organization (CDMO) based in Indianapolis, IN, with additional locations in South Bend and Bunker Hill, IN, Danbury, CT and Europe. We are seeking an experienced Chemist, Radiochemical Manufacturing to join our growing company to join the staff at our Bunker Hill, IN facility. The Chemist, Radiochemical Manufacturing will be responsible for the manufacturing of time sensitive radiopharmaceuticals in an integrity driven, highly regulated environment (i.e.

FDA, NRC, DOT

) to support patient treatment through disease diagnosis, staging, and monitoring. As part of the production team, you will be responsible for process manufacturing with radioisotope materials, preparation of production materials, maintaining supplies and production materials, general maintenance of production equipment and analytical equipment and adhering the policies and procedures within an FDA regulated environment.

ESSENTIAL FUNCTIONS

The primary work environment consists of working within a radioisotope producing cyclotron facility and associated manufacturing facility to produce radiopharmaceuticals—which must be kept clean, orderly, and maintained in optimum operating condition. Must be able to provide timely information to his or her Supervisor regarding status, foreseeable problems or failure. Must be willing to work shifts to support 24/7 work week schedules such as 2nd and 3rd shifts as well as uncommon work schedules (e.g., Sunday

• Thursday or Wednesday
• Sunday).

During various phases of drug development, higher pace and longer work weeks are anticipated to meet company objectives. Radiochemical Manufacturing Chemists are expected to be available and/or shift their work schedules during higher pace periods. Scheduled Paid Time Off (PTO) will generally be limited during these periods or may not be authorized without sufficient advance request (> 30 days). Additionally, there may be scheduled time-off or planned "Plant shutdown" periods requiring the use of PTO or taken unpaid. Must be flexible to perform other related duties as assigned to support overall operations and company objectives. The facility is operated under well-controlled and closely monitored conditions that are regulated by both State and Federal agencies, and that are enforced by the internal corporate Quality Assurance (QA) and the Environmental, Health, and Safety (EHS) group. Radiochemical manufacturing chemical manufacturing chemists are expected to read, understand, and comply with corporate, state and federal regulations and policies. Employees are trained and expected to execute Standard Operating Procedures (SOPs) in accordance with current Good Manufacturing Practices (cGMP) requirements including Good Documentation Practices (GDP). Must work in partnership with cross functional teams to ensure product/production standards are met. Chemists are trained to safely work with radioactive materials under the direction of Authorized Users (AU) and the Radiation Safety Officer (RSO). Due to the nature of the required work, employees will be exposed to amounts of radiation that are well below the maximum limits deemed safe by current standards. Employees continuously monitored and their exposure to radiation will be recorded and available for review. Each staff member will receive specific training in keeping radiation exposure below regulated limits, but also work habits that are consistent with the principals of ALARA (As-Low-As-Reasonably-Achievable). Noise levels within the facilities are considered low to moderate. Job duties will often require long periods of standing.

KNOWLEDGE-SKILLS-ABILITIES

Physical Ability

• Manual dexterity required for equipment operation and occasional reach and lifting of small objects. Customer and Personal Service
• Knowledge of principles and processes for providing customer and personal services. This includes customer needs assessment, meeting quality standards for services, and evaluation of customer satisfaction. Active Listening
• Giving full attention to what other people are saying, taking time to understand the points being made, asking questions as appropriate, and not interrupting at inappropriate times. Speaking
• Talking to others to convey information effectively. Critical Thinking
• Using logic and reasoning to identify the strengths and weaknesses of alternative solutions, conclusions, or approaches to problems. Time Management
• Managing one's own time and the time of others. Active Learning
• Understanding the implications of new information for both current and future problem-solving and decision-making. Coordination
• Adjusting actions in relation to others' actions. Oral Comprehension
• The ability to listen to and understand information and ideas presented through spoken words and sentences. Oral Expression
• The ability to communicate information and ideas in speaking so others will understand. Written Comprehension
• The ability to read and understand information and ideas presented in writing. Written Expression
• The ability to communicate information and ideas in writing so others will understand. Deductive Reasoning
• The ability to apply general rules to specific problems to produce answers that make sense. TRAVEL Travel
• up to 30% (may require overnight stay for 1 or more nights)

REQUIRED EDUCATION AND EXPERIENCE

Bachelor's Degree in Chemistry, Pharmaceutical Sciences, or other applicable degree preferred. Must have prior experience working with HPLC and GC Ability to follow instructions accurately and work as a member of a team Prior experience in manufacturing, preferably in a controlled environment and/or regulated industry desired. Ability to manage several tasks at the same time. Ability to train and be trained Thorough understanding of project management. Excellent organizational skills and attention to detail.

ADDITIONAL REQUIREMENTS

Valid Indiana driver's license Pass a Background Check.

ADDITIONAL INFORMATION/BENEFITS

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. We recognize that people come with a wealth of experience and talent beyond just the technical requirements of the job. If your experience is close to what you see listed here, please still consider applying. Diversity of experience and skills combined with passion is a key to innovation and excellence; therefore, we encourage people from all backgrounds to apply to our positions. Please let us know if you require accommodations during the interview process. We are an equal opportunity employer. Qualified applicants shall be considered for all positions without regard to race, color, sex, religion, national origin, age, disability, veteran status, or any other status protected by federal, state or local law. Refusal to submit to testing will result in disqualification of further employment consideration.