SpectronRx is a growing Contract Development and Manufacturing Organization (CDMO) based in Indianapolis, Indiana, and production locations in South Bend, IN; Bunker Hill, IN; and Danbury, CT with plans for additional future production facilities. 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 while adhering the policies and procedures within the 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.
- 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.
- 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).
- Chemists are trained to safely work with radioactive materials under the direction of Authorized Users but will be exposed to low amounts of radiation that are well below the maximum limits deemed safe by current standards.
- Each staff member will receive specific training in keeping radiation exposures within regulatory guidelines—consistent with the principal of ALARA (As-Low-As-Reasonably-Achievable)—and he/she will be routinely monitored for their exposure to radiation.
- Must be able to provide timely information to his or her Supervisor regarding status, foreseeable problems or failure.
- Must work in partnership with cross functional teams to ensure product/production
- Noise levels within the facilities are considered low to moderate
- Must be flexible to performs other related duties as assigned.
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
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.
Job Type: Full-time
Pay: $22.00 - $30.00 per hour
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Employee discount
- Flexible spending account
- Health insurance
- Health savings account
- Life insurance
- Paid time off
- Retirement plan
- Vision insurance
Schedule:
- 10 hour shift
- 8 hour shift
- Day shift
- Monday to Friday
Education:
Experience:
- Chemistry, manufacturing & controls: 1 year (Preferred)
License/Certification:
- Driver's License (Required)
Shift availability:
- Day Shift (Preferred)
- Night Shift (Preferred)
- Overnight Shift (Preferred)
Ability to Commute:
- Bunker Hill, IN (Required)
Ability to Relocate:
- Bunker Hill, IN: Relocate before starting work (Required)
Work Location: In person
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