Manufacturing Specialist

SpectronRx•South Bend, IN

6d•Onsite

About The Position

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 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

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.
Be able to lift 50 pounds with no restrictions.
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.
Valid Indiana driver's license
Pass a Background Check.

Nice To Haves

Aseptic processing experience preferred.

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 of 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.