Chemist - Pharmaceutical Investigations Team bei Lilly

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.

Organization/Position Overview:

The Global Quality Analytical Sciences and Quality Control Operations (AQCO) organization resides within Central Quality. AQCO provides quality, scientific, and process leadership, supporting global functions, internal and external business partners, and regulatory authorities. AQCO aids in problem-solving, developing sustainable control strategies, influencing operational excellence, and defining and/or replicating quality best practices.

The Chemist – QC, is a member of AQCO’s Pharmaceutical Investigations Team, an established Center of Excellence. This position will provide technical support utilizing a variety of analytical techniques, instrumentation, and other IT Tools and resources to evaluate suspect drug substances, drug products, packaging/devices, and other non-typical samples/materials. Investigations may include physical and/or chemical analyses of samples (obtained globally from product complaints, proactive surveillance, or law enforcement/government agencies) suspected to involve counterfeiting, tampering, diversion and/or samples related to other GQL-supported projects. Any applicant currently in the R1 - R4 range will be considered for this role.

Responsibilities / Key Objectives / Deliverables:

The Chemist – QC will be expected to:

• Perform non-routine sample analyses of suspect samples utilizing HPLC, NIR, FTIR, LC-MS, etc. (T)

• Produce quality documentation for internal and external use and ensure data documentation meets ALCOA plus expectations. (T)

• Perform non-laboratory investigative tasks involved in the processing of suspect samples (e.g., data entry, photographs, packaging variable data verification, packaging evaluations, author technical reports etc.). (T)

• Learn and utilize basic development, manufacturing, and regulatory processes, and develop an awareness of analytical and pharmaceutical industry trends related to product authentication. (T)

• Identify areas of continuous improvement either in technical execution or in business operations and propose solutions. (T)

• Identify areas of self-improvement and gain alignment with supervisor to identify development opportunities. (T)

• Develop the ability to testify in a court of law, if necessary. (T)

• Utilize quality systems and understand regulatory requirements. (INF)

• Identify a mentor and establish learning opportunities. (KSM)

• Work safely and in compliance with applicable quality, environmental, and safety expectations.

• Ensure laboratory work is conducted with an inspection readiness mindset. (PB)

• Escalate both technical and compliance issues, when appropriate. (PB)

• Work collaboratively with people in GQL and with cross-functional business partners (PB)

• Adjust priorities and maintain flexibility to meet customer needs / expectations. (PB)

Technical (T); Impact (IMP); Influence (INF); Knowledge Sharing & Mentoring (KSM); Performance Behaviors (PB)

Basic Qualifications

• Education: Bachelor’s degree in chemistry, biology(or related field), or equivalent work experience

• 1-3 years of pharmaceutical experience.

• Ability to handle Controlled Substances / Special Security Substances

Additional Skills / Preferences:

• 2-3 years prior experience in GMP laboratory environment.

• Current experience with IR, NIR, Raman, HPLC, or LC-MS

• Current experience with basic analytical techniques (e.g., balances, pH meter, etc.).

• Current experience in using various IT Tools such as: Veeva (QDocs), SmartLab, BLUE, NuGenesis, Empower, Tableau, CIMS, Trackwise, SAP, Fiori, etc.

• Experience with authoring technical documents/reports.

• Basic knowledge of printed packaging materials / processes.

• Knowledge of Lilly product delivery systems / devices.

• Strong technical problem-solving ability, learning agility, and be able to work productively with cross functional teams.

• Ability to balance multiple activities, prioritize and handle ambiguity.

• Ability to execute well-defined protocols/procedures with minimal oversight.

• Ability to develop/author basic protocols.

• Able to effectively communicate basic information with cross-functional business partners (written and oral).

• Experience with evaluating new technologies and/or improvements to existing technologies.

• Experience with Deviation & Change Control Processes.

• Experience with handling confidential/privileged information.

• Experience with MS Office tools.

Additional Information:

• Location: Indianapolis, IN

• Shift: 1st

• Travel: Minimal (<5%)

• Potential exposure to chemicals, allergens, and loud noises.

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

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.

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