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Manufacturing Specialist
COMPANY OVERVIEW
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 Manufacturing Specialist to join our growing company. The Manufacturing Specialist will be responsible for process manufacturing of radiopharmaceutical products, preparation of production materials, supplies, and general production equipment maintenance.
ESSENTIAL FUNCTIONS
Carries out production responsibilities to meet manufacturing schedules.
Performs chemistry manipulations for production in a GMP environment.
Ensure regulatory compliance of production protocols within the manufacturing operations.
Analytical methods and procedures for testing GMP manufactured radiopharmaceutical products.
Prepare and submit required reports.
Supporting and executing deviation reports, OOS, root cause investigations and CAPA.
Optimize and validate methods and procedures for radiopharmaceutical products.
Assist with creating SOPs for use in production.
Assist with the preparation of regulatory submissions.
Assist with general lab cleaning, supplies and maintenance.
Assist with waste management.
Performs other related duties as assigned.
Physical Ability – Must be able to lift up to 50 pounds at a time and stand for prolonged periods.
Attention to Detail – Ability to accurately count, verify, and record data.
Active Listening – Giving full attention to instructions and communications, asking questions as appropriate.
Speaking – Talking to others to convey information effectively.
Time Management – Managing own time to prioritize tasks and meet deadlines.
Coordination – Adjusting actions in relation to others’ actions in a team environment.
Oral Comprehension – The ability to listen to and understand information and ideas presented through spoken words and sentences.
Written Comprehension – The ability to read and understand information and ideas presented in writing.
Basic Math Skills – Ability to count accurately and perform basic arithmetic for reconciliation.
Organizational Skills – Ability to maintain orderly areas and accurate records.
TRAVEL
Regular travel is minimal.
REQUIRED EDUCATION AND EXPERIENCE
An associate’s degree in chemistry, biochemistry, chemical engineering, or a related field, along with a minimum of 2 years of related experience in a pharmaceutical manufacturing environment (with preference to radiopharmaceuticals) may be considered.
Prior experience in pharmaceuticals, preferably in a quality or production position, is ideal.
Prior experience in a radiopharmaceutical environment a plus.
Excellent communication, analytical, computer/PC and technical writing skills.
The ability to handle responsibilities in a fast-paced manufacturing environment.
Demonstrated ability to work as part of a team.
Thorough understanding of project management.
Excellent organizational skills and attention to detail.
PREFERRED EDUCATION AND EXPERIENCE
A bachelor’s degree in chemistry, biochemistry, chemical engineering, or a related field preferred.
Aseptic processing experience preferred.
Excellent communication, analytical, computer/PC and technical writing skills.
Ability to train and be trained.
ADDITIONAL REQUIREMENTS
Valid Indiana driver’s license.
Pass a Background Check.
Prolonged periods of standing, walking, bending, and lifting.
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 accommodation 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.