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.

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

Organization Overview:
Analytical Sciences and Quality Control Operations (AQCO) is a center of excellence for analytical stewardship, method lifecycle management (development/validation/transfer and troubleshooting), technology transfer, and analytical troubleshooting.  Our responsibilities include analytical/technical support for Lilly manufacturing sites, external partners, as well as the development, and clinical areas.

Position Overview:

The Advisor - Analytical Stewardship, AQCO will include a combination of laboratory activities and method transfer activities. Laboratory work may include method optimization, reagent qualifications, or other experimental determinations. Method transfer may include hands on analyst training, and authoring/reviewing documentation to move the molecule from the Development phase to the Commercial phase. The qualified individual will be expected to collaborate with third parties, development laboratories, and international testing laboratories. The qualified individual will also be expected to communicate results and processes effectively in presentation and written reports, and to participate in cross-functional teams actively and cooperatively.

Responsibilities:

Transfer analytical methods for marketed products to Third Party manufacturers or other QC laboratories.

Ensure that method validation packages are consistent with current regulatory expectations. This includes evaluating existing method validation data and taking actions to facilitate updating packages or providing additional data to support method changes/laboratory practice changes, as needed.

Execute method development work and implementation of method improvements for marketed products (including laboratory work, training/transfer of new methods to labs, implementation of new technologies/improve existing technologies change controls, and regulatory submissions).

Develop method assessments for marketed product control strategies and addresses deficiencies and areas for improvement identified in the assessments.

Understand basic development, manufacturing, and regulatory processes, and maintain awareness of analytical and pharmaceutical industry trends.

Balance needs/workload for multiple projects simultaneously.

Establish relationships with Development or Third parties to enable development, optimization, or validation of analytical methods.

Interact with development laboratories for training and utilization of new technologies.

Provide updates to supervision regarding progress and issues.

Conduct reference standard evaluations including consultation on the protocol, review of profile and associated documentation.

Ensure compliance with applicable quality, environmental, and safety expectations.

Basic Requirements:

PhD Degree in Chemistry, Biochemistry, or related field and a minimum of 3 years’ experience in pharma/biotech industry, OR

BS/MS in Chemistry, Biochemistry, or related field and a minimum of 5 years’ experience in pharma/biotech industry.

Demonstrated experience and proficiency with pharmaceutical manufacturing and working knowledge of regulatory expectations.

Additional Skills/Preferences:

Extensive hands-on experience with analytical techniques, analyses, and instrumentation, related to large and small molecules.

Bilingual (English/Spanish).

Proven oral and written communication skills.

Understanding of GMP quality systems.

Knowledge about FDA/EMA regulations on method validation.

Ability to influence diverse groups and effectively manage relationships.

Demonstrated ability to teach, train, and supervise other scientists.

Strong compliance mindset and sound judgement.

Additional Information:

Primary location Puerto Rico supporting internal and external manufacturing sites.

This position is banded across multiple levels, and the job title received upon hire might not be the posting title. Business titles are dependent upon employee level.

Some travel may be required (Approximately 5-10 percent).

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.

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 an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, 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 help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women’s Network, Working and Living with Disabilities. Learn more about all of our groups.

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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