Associate Consultant - Biologist- Quality Control

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 Overview: At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.

Position Brand Description: The Associate Consultant Biologist for QC commercialization support commercialization activities for laboratories within Indianapolis Parenteral Manufacturing.  Responsibilities include method transfers, validations, or verifications of new molecules, collaboration with global analytical stewards, local change controls, and following Laboratory Quality Systems (LQS) and Global Quality Systems (GQS) for Parenteral QC.  Serve as a local data steward / laboratory key site contact for global site impacts.

Responsibilities:

• Responsible for maintaining a safe work environment, working safely, and accountable for supporting all HSE Corporate and Site Goals.

• Champion for Site Impact Assessment for Compendial and GQS updates.

• Act as local data steward / laboratory key site contact for new molecule implementation in the laboratory.

• Lead / Supervise method transfers, validations, or verifications for new molecules in the laboratory.

• Author technical documents to support commercialization, method transfers, validations or verifications, as applicable. Author change controls to support commercialization, new methods, new reference standards, etc.

• Participate in APLOT and commercialization meetings.

• Complete steps for global changes, as applicable.

• Support global analytical stewards by gathering information on new methods.

• Work closely with GQL and PR&D to help guide and provide expectation was it relates to new methods.

• Support audit activities.

• Local technical SME for all micro methods

• Method management for respective IPM Laboratories.

• Technical review, interpretation and release of data including CoT issuance, stability results and reference standard characterization.

• Perform technical training.

• Coach lab analysts in real time.

• Mentor analysts through formal process / program.

• Review and approve change controls and deviations.

• Review and interpret data and document results of analyses and conclusions accurately and thoroughly in summary reports in accordance with GMP and local guidelines.

• Develop investigational testing protocols and perform testing as required.

• Method validation / remediation.

• Research and recommend new technologies.

Basic Requirements:

• BSc or MSc in scientific or technical degree: chemistry, biology, engineering, or equivalent scientific / technical degree

• 3 Years + experience in a GMP QC laboratory and/or pharmaceutical industry

• Demonstrated ability to lead projects

• Experience supporting regulatory inspections

• Strong influencing skills and interpersonal and teamwork skills

• Both strong technical writing and communication skills

• Strong self-management and organizational skills

• Responsible for maintaining a safe work environment, working safely, and accountable for supporting all HSE Corporate and Site Goals

Additional Skills/Preferences

• Demonstrated proficiency in complex laboratory analysis including, but not limited to chromatographic, spectroscopic and / or microbiological assays

• Ability to work in a lab environment including wearing appropriate PPE and other safety related equipment or considerations

• Deep understanding of compliance requirements and regulatory expectations.

Additional Information:

• Ability to work 8 hour days – Monday through Friday

• Ability to cover weekends, holidays, and company shutdowns as needed.

• Minimal travel required.

• Applicant will work in various areas within the Parenteral Plant.  Some allergens are present in the parenteral plant. Mobility requirements and exposure to allergens should be considered when applying for this position.

• Tasks may require repetitive motion (e.g., keyboarding).

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

$65,250 - $169,400

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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