Senior Manufacturing Chemist Job at Beacon Hill (Indianapolis)

Job Description

The Senior Manufacturing Chemist will serve as part of the production team responsible for the processing of bulk radiopharmaceuticals including production preparation and equipment maintenance activities in a highly regulated (FDA/NRC) environment.

Job Responsibility

Ensure a safe and quality working environment through training, awareness, and compliance to safety guidelines, SOP’s and cGMP
Must maintain operational compliance with US and international regulatory agencies and guidelines (i.e. FDA, EU, HC, TGA, PIC/S, ISO, USP, NRC, cGMP, etc.)
Manufacture radiopharmaceutical products, prepare production materials and supplies, perform general production equipment maintenance, and production inventory management
Carry out production responsibilities including cross-functional coordination to meet the manufacturing schedule
Assist in the general lab cleaning and stocking of supplies
Ensure regulatory compliance
Create and optimize SOPs as needed
Create and execute protocols as needed
Support and execute Continuous Process Improvement (CPI) initiatives through implementation of CAPA, protocols and Change Control
Author Quality Events as needed (deviations, OOS, CAPA, CC)
Provide training as needed to Production Chemists
Troubleshoot problems including those of a complex nature
Develop and promote equipment and process improvements which serve to improve reliability, increase output, and reduce radiation exposure
Assist in driving cost savings initiatives for the department
Ensure department safety, quality, and financial metrics are achieved
Must actively manage personal radiation exposure as well as exposures of shift personnel per prescribed policies, procedures, and guidelines
Must maintain Class 1 Radiation Worker training qualifications
Collateral duties, special projects and other duties assigned by Management

Requirements

Bachelor degree in Chemistry, Biochemistry, Chemical Engineering, or a related field
3 or more years of relevant experience required
Proven abilities to handle responsibilities in a demanding manufacturing environment with minimal oversight
Experience with Chemistry related equipment
Experience working in a GMP environment
Familiarity with cyclotron solid targets along with the dissolution and separation of radioisotopes preferred
Familiarity with radiation protection and safe handling of radioactive materials preferred
Skills/Competencies: Action Oriented, Problem Solving, Decision Quality, Directing Others, Technical Writing Skills, Written Communications, Creativity and Organization
Good team building and collaborative mindset

Nice to have

Familiarity with cyclotron solid targets along with the dissolution and separation of radioisotopes
Familiarity with radiation protection and safe handling of radioactive materials

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Senior Manufacturing Chemist

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