Quality Excellence Associate Chemist Jobs in Indiana

Develop advanced knowledge in cGMP, CFR and other regulations in order to assure laboratory compliance.

Assist in critical reagent qualification/re-qualification, in compendia methods and other analytical method qualification/validation/transfer.

1+ years industrial experience in biopharmaceutical industry, such as Microbiology, Biology, or related field experience

We are looking for professionals with these required skills to achieve our goals:

Conduct routine non-compendial, biochemistry, analytical testing for in-process, release, and stability drug product samples per SOP.

Analytical methods include HPLC, Capillary Electrophoresis, SoloVPE and others.

Support the design, qualification, and commissioning of facilities and equipment in relation to parenteral radiopharmaceutical drug product manufacturing.

Adhere to all applicable procedures, cGMPs, company policies and any other quality or regulatory requirements.

BS/BA degree in chemistry, chemical engineering, or a related discipline. Experience with radiopharmaceuticals and/or use of radioactive materials is preferred.

Strong quantitative reasoning skills and a background in mathematics.

2 years of relevant industry experience in parenteral drug product manufacturing, and/or process support/development.

Experience working in a pharmaceutical GMP manufacturing environment is preferred.