Chemist – QC

Location Type: Not Specified

 

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.

Company Overview:

At Lilly, we serve an extraordinary purpose. For more than 140 years, we have worked tirelessly to discover medicines that make life better. These discoveries start in Lilly Research Laboratories, where our scientists work to create new medicines that will help solve our world’s greatest health challenges.

This role is at the CORE Indianapolis facility, formerly Point Biopharma. The Center of Radioligand Excellence (CORE) is responsible for the Commercial launch of RLTs, supply of late-stage investigational products, and scale-up/optimization for Ph3 and commercial launches.

Job Description:

The Chemist / Sr. Chemist / Principal Chemist, role is focused on the quality control testing of the various radiopharmaceutical products manufactured at the Lilly CORE site. All testing performed is in accordance with the established drug product and API release specifications. Perform technical transfers, 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, non-conformances, and OOS (Out of Specification) events associated with products tested at the Lilly CORE facility.

Responsibilities:

• 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 in and contributing to the maintenance and calibration of analytical instruments within the quality control laboratories.
• Collaborating with TS/MS, 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, cGMP, company policies and any other quality or regulatory requirements.
• Working well in a fast-paced team environment.
• Collaborate with management to identify training needs and ensure appropriateness of training plans, creating and assigning curricula as required.
• Contribute to the training, education, guidance, and influence of operational and support areas on quality control policy and practices.
• Fosters a culture of collaboration, partnership, teamwork, and a drive for change and continuous improvement
• Perform other duties as assigned

Basic Qualifications:

• Bachelor’s degree in chemistry or related field
• 3+ years of relevant industry experience in analytical laboratories is required (including experience in analytical instrumentation technologies, chromatography methods, USP compendial test methods, ICH guidelines, HPLC analytical testing, method development, and method validation)

Additional Preferences:

• MS or PhD is preferred
• An excellent understanding and knowledge of analytical instrumentation technologies, chromatography methods, USP compendial test methods, ICH guidelines, and cGMP.
• 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.
• Strong communication and organizational skills.
• Proficiency in Microsoft Office suite applications (Excel, Word, PowerPoint).
• Ability to handle multiple tasks simultaneously while meeting deadlines.
• Ability to investigate, collect data, and analyze trends investigations.
• Ability to work as needed for off-hours stability timepoints and potential early start times (4am)
• Excellent communication (written and verbal), interpersonal, organizational and negotiation skills.
• Project management skills, experience in process improvement, and the ability to be solution focused on the design and implementation of quality and process improvements

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is
$63,000 – $162,800

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

#WeAreLilly