Sr. / Principal Chemist – QC – IAPI (eSystems)

Initial Therapeutics, Inc.; Indianapolis (IN); On-site; USD 63,000 - 162,800; Full time

Benefits offered by this job

401(k) plan

Pension

Vacation benefits

Medical benefits

Dental benefits

Vision benefits

Life insurance

Employee assistance program

Job summary

A leading company in the healthcare sector is seeking a Chemist for their QC team in Indianapolis. The role involves providing technical and compliance support for electronic systems in laboratory operations. Candidates should have a strong background in scientific fields and experience in GMP laboratories. This position requires onsite presence at least four days a week, with opportunities for professional growth and a comprehensive benefits package.

Qualifications

• 3+ years of relevant experience in a GMP laboratory.
• 3+ Years of QC experience with a focus on electronic lab notebooks.

Responsibilities

• Provide support for implementation and maintenance of electronic notebooks.
• Lead investigations affecting data integrity and recommend solutions.
• Train and mentor analysts through formal processes.

Skills

Communication

Investigation

Education

Bachelor’s Degree in a scientific field

Tools

TrackWise

SmartLab

Empower

NuGenesis

Job description

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.

Position Brand Description:

The Chemist – QC – IAPI (QC eSystems) provides electronic system technical and compliance support for Indianapolis API Operations QC. The Chemist – QC – IAPI is responsible for design and execution validated computer systems, analytical method management, electronic notebook templates/scripting, investigations, and QC infrastructure connections. The Chemist – QC – IAPI will provide support for other support activities (i.e.: support, new equipment installation, data integrity, agency and internal inspections, system upgrades, change management, observation/deviation management, reviews, and related global initiatives).

Key Objectives/Deliverables:

• Provide support for the implementation and maintenance of electronic notebooks (ie. Smartlab, MODA, NuGenesis, etc)
• Subject expert for laboratory computer system audit activities, validation and periodic reviews
• Interacts effectively with business partners to communicate and resolve issues and gain a clear and accurate understanding of each other’s requirements
• Understands direction of technology and its impact on laboratory business processes, quality systems and the QC organization
• Implements programs/processes which improve overall compliance and quality in the QC Laboratories
• Train and Mentor analysts through formal process/program
• Assess, review and author change controls and deviations for eSystems and QC instrumentation
• Utilize technical skills to lead or perform in-depth investigations affecting data integrity. Draws conclusions and performs root cause analysis investigations and recommends solution to prevent reoccurrence
• Support laboratory infrastructure and act as a liaison between QC and the IT organization (e.g., instrument interfacing, data archiving, technology infrastructure and data parsing)
• Evaluate new laboratory technologies for impact to other QC systems portfolio and provide direction in qualification of new equipment technologies
• Improve laboratory quality systems; develop content, review and approve SOPs and training as necessary
• Influences business areas’ understanding of their own business processes, identifies new opportunities, challenges the status quo, and helps develop recommendation for using QC eSystems to improve business process productivity

Basic Requirements:

• Bachelor’s Degree in a scientific field related to the lab (e.g., Chemistry, Microbiology or Biology)
• 3+ years of relevant experience in a GMP laboratory.

Additional Preferences:

• 3+ Years of QC experience with a focus on electronic lab notebooks and instrument infrastructure.
• Deep understanding of laboratory quality systems and their dependencies (e.g., TrackWise, SmartLab, Darwin, Empower, NuGenesis and instrument controlling laboratory systems)
• Proficiency with computer systems and operating systems
• Demonstrate strong oral, written communication and interpersonal interaction skills

Other Information:

• Occasional on-call support coverage
• This role requires the individual to be onsite in Indianapolis, IN at least 4 days per week and is not approved for remote work

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.

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