Chemist-Commercialization

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work-but it's work worth doing. If you're driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

Patients are at the center of everything we do at Lilly. We are currently hiring a Chemist-Commercialization.

This role supports critical work that helps bring medicines and solutions to patients responsibly and efficiently. #WeAreLilly

Job Overview:

The Sr. Chemist Commercialization will provide technical support to Quality Control Laboratory (QCL) operations and lead method transfer, verification, and validation activities for new and existing products. Reporting to the Associate Director-Quality Control Laboratory, she/he will evaluate and recommend new analytical techniques and equipment, develop and improve analytical methods to reduce variability and cycle time, and serve as the technical liaison between the PR01 Laboratory, Global Lab Resources (including SMDD and AQCO), and applicable Lilly sites. She/he will participate as Lead Investigator in laboratory incidents and deviations as needed, ensuring that suspect results and out-of-specification situations are thoroughly investigated and resolved. The Sr. Chemist Commercialization will help meet analysis cycle time requirements by quickly resolving technical issues during process validation and normal operations for new products. She/he will assess the technical skills of QCL personnel, recommend development plans, and design training or process schools to facilitate analyst growth. Additional responsibilities include preparation and review of laboratory documents (method transfer, verification, and validation protocols and procedures), assuring safety and data integrity in all method-related activities, supporting GMP inspection readiness and participation (FDA, EMA, Japan, and others), and ensuring compliance with Global Quality Standards for analytical testing, equipment, and deviation management.

Basic Requirements:

• MS or PhD in Chemistry, Biochemistry, Analytical Chemistry, or a related scientific discipline. PhD is preferred.
• Five (5) years of experience in a laboratory environment. For PhD applicants, relevant analytical or quality laboratory experience is required.
• Chemist license preferred.
• Knowledge of current Good Manufacturing Practices (cGMPs) and Good Laboratory Practices (GLPs).
• Experience with analytical and biochemical techniques, including method development, validation, and transfer.
• Strong technical writing and presentation skills.
• Strong data analysis capabilities with attention to detail.
• Excellent interpersonal skills that promote engagement and teamwork within
• Fully bilingual (English/Spanish) with written, verbal, and oral communication skills.
• Teamwork oriented.
• Demonstrated leadership and mentoring skills.
• Excellent communication skills, both oral and written.
• Ability to work with multiple assignments simultaneously and within an environment with distractions.
• Complex problem-solving and critical decision-making ability.
• Proficiency with computer applications relevant to laboratory operations.
• Self-motivated with ability to work under minimal supervision.

Responsabilities:

• Evaluate and recommend new technology aligned with efforts to improve productivity and reduce variability.
• Develop, improve, and validate analytical methods for Laboratories, including new products; coordinate proposed changes with Indianapolis laboratories and/or applicable Sites.
• Provide technical support to the laboratory during process validation and normal operations for new products, resolving technical issues in a timely manner.
• Participate as Lead Investigator in laboratory incidents/deviations as needed.
• Assess technical skills of QCL personnel, recommend development plans, and design training or process schools.
• Serve as the liaison between Global Lab Resources (SMDD, GQL) and the PR01 Laboratory to facilitate transfer of information among Sites.
• Prepare and/or review laboratory documents including method transfer, verification, and validation protocols and procedures.
• Assure safety and data integrity aspects are considered during method transfer and validation for new products.
• Participate in regulatory external and internal inspections (FDA, EMA, Japan, among others) and GMP inspection readiness.

Important Notice: In order to maintain the excellent reputation of our company, the quality of our products, and the safety of our working environment, the company will take all reasonable measures to ensure that drug abuse by employees or other persons does not jeopardize the safety of our operations or the quality of our products or adversely affect in any way the company or its employees. The company recognizes that drug use both on and off the job can be detrimental to the company and its efforts to provide a drug-free workplace. Even if prescribed under a state medical marijuana law, marijuana remains illegal under federal law. Marijuana is considered unauthorized by Lilly.

"Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1."

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 () 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 (AMECA), Black Employees at Lilly (Ver el correo electrónico en pharmadiversityjobboard.com), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women's Initiative for Leading at Lilly (WILL).

Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$52,500 - $154,000

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