Pharmaceutical Manufacturer

SpectronRx•Indianapolis, IN

1d•Onsite

About The Position

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.

Requirements

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.
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.
Valid Indiana driver’s license.
Pass a Background Check.
Prolonged periods of standing, walking, bending, and lifting.

Nice To Haves

Prior experience in a radiopharmaceutical environment a plus.
A bachelor’s degree in chemistry, biochemistry, chemical engineering, or a related field preferred.
Aseptic processing experience preferred.
Ability to train and be trained.

Responsibilities

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.