Sr. Chemist, Qc

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

POINT Biopharma Global Inc. is a globally focused radiopharmaceutical company building a platform for the clinical development and commercialization of radioligands that fight cancer. Recently acquired by Eli Lilly and Company, POINT aims to transform precision oncology by combining a portfolio of targeted radioligand assets, a seasoned management team, an industry-leading pipeline, in-house manufacturing capabilities, and secured supply for medical isotopes including actinium-225 and lutetium-177. POINT is a wholly owned subsidiary of Eli Lilly and Company.

Position Summary:

Reporting to the Supervisor, Quality Control, the Chemist will execute QC testing in accordance with established drug product and API release specifications. Perform technical transfer, development, and validation of analytical test methods associated with finished dosage form (FDF) drug products and API radioisotope products. Deliver investigation, resolution, and mitigation of deviations, nonconformances,’ and OOS (Out of Specification) events associated with product tested at the POINT GMP facility.

Roles and Responsibilities of the Position:

• Develop and validate analytical methods associated with the testing of drug products, APls, and raw materials, including chromatography methods (i.e., UHPLC, TLC, and GC) and spectroscopy methods (i.e., ICP-MS and gamma spectroscopy) according to phase appropriate guidelines (ex. cGLP, cGMP).

• Prepare and execute method validation protocols associated with POINT drug products produced at the manufacturing facility and in accordance with applicable compendia! (ex. USP) and ICH guidelines, as well as the established Quality Management System.

• Ensure all drug products are tested in accordance with highest standards of Good Manufacturing Practice (GMP), ICH guidelines, and according to regulatory guidelines, laws and Standard Operating Procedures (SOPs).

• Conduct chemical and physical testing of raw materials, API, in-process, radioactive finished products, and stability samples, using established test methods to provide accurate and reliable data to assure their strength, identity, and purity.

• Work with radioactive materials using safe protocols to maintain ALARA.

• Maintaining accurate and complete lab data notebooks as per cGLP and/or cGMP, as appropriate.

• Recording and reporting results of analysis in accordance with approved lab procedures, standard test methods and systems.

• Participating and contributing to the maintenance and calibration of analytical instruments within the quality control laboratories.

• Collaborating with Process Chemistry, QA, CMC, and Regulatory colleagues to establish release and stability specifications for starting materials, intermediates, drug substances and drug products.

• Adhering to all applicable procedures, cGLP, cGMPs, company policies and any other quality or regulatory requirements

Required Qualifications:

• BS/BA degree in Chemistry required.

• 3 to 5 years of relevant industry experience in analytical laboratories is required.

• An excellent understanding and knowledge of analytical instrumentation technologies, chromatography methods, USP compendia! test methods, ICH guidelines, and good manufacturing practices.

• Experience with HPLC analytical testing, method development, and method validation is required.

• The position requires experience performing routine testing of production batches and stability batches.

Additional Preferences:

• MS or PhD in Chemistry is preferred Experience with HPLC analytical testing, method development, and method validation is required.

• Experience working with radiopharmaceuticals will be considered an asset but is not a requirement Experience working in a pharmaceutical GMP manufacturing environment is preferred.  

Physical Demands/Travel:

The physical demands of this job are consistent with a lab environment/ manufacturing environment.

*This role will require shift work with occasional early start times (as early as 4 AM), as well as evenings and alternating weekend work and holidays.

The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

Work Environment:

This position’s work environment is in a Lab/Manufacturing site.

Theworkenvironmentcharacteristicsdescribedherearerepresentative of those an employee encounters while performing the essential functions of this job.

*To perform this job successfully, an individual must be able to perform the role and responsibilities satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

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