QC Scientist - Analytical Equipment Support

Initial Therapeutics, Inc.; Lebanon (IN); On-site; USD 63,000 - 163,000; Full time

Job summary

A leading healthcare company is seeking an Analytical Equipment Support Group Scientist to provide technical leadership in maintaining advanced analytical equipment for a new manufacturing facility in Lebanon, IN. The role involves collaboration with cross-functional teams, troubleshooting, and ensuring compliance with regulations. Ideal candidates will have a strong engineering focus and experience in a GMP regulated environment.

Benefits

401(k) plan

Pension

Vacation benefits

Medical benefits

Dental benefits

Vision benefits

Life insurance

Employee assistance program

Qualifications

• 1+ year of experience in a GMP regulated environment or 10+ years in similar role.
• Experience in troubleshooting and resolving equipment issues.

Responsibilities

• Manage and maintain advanced analytical equipment.
• Collaborate with cross-functional teams to integrate analytical findings.
• Troubleshoot and resolve equipment issues.

Skills

Teamwork

Decision making

Problem solving

Communication

Education

Bachelor’s degree in chemistry or engineering

Tools

Spectroscopy

Chromatography

Mass spectrometry

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.

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 35,000 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.

Lilly is currently constructing an advanced manufacturing facility for production of API molecules located in Lebanon, IN. This facility is Lilly’s largest investment in manufacturing capacity and is intended to provide APIs for current and future products. This is a unique opportunity to be a part of the leadership team for the startup of a greenfield manufacturing site, and the successful candidate will help to build the organization, the facility and the culture to enable a successful startup into GMP manufacturing operations.

Position Description:

The Analytical Equipment Support Group (AESG) Scientist provides technical leadership and expertise for analytical instrumentation. We are seeking a skilled scientist with a strong engineering focus to join our team. The ideal candidate will be responsible for maintaining advanced analytical equipment and helping to ensure the accuracy and reliability of data gathered from these instruments. This role involves collaborating with cross-functional teams, troubleshooting equipment issues, and contributing to the development of engineering solutions to a variety of advanced QC analytical equipment. The scientist will also complete technical review of protocols and reports. They will also share technical information and best practice within the group.

Key Objectives/Deliverables:

• Manage and maintain advanced analytical equipment, ensuring optimal performance and reliability.

• Collaborate with cross-functional teams to integrate analytical findings into practical applications.

• Troubleshoot and resolve equipment issues, performing routine maintenance, calibration and qualification activities.

• Design and implement engineering improvements to enhance equipment performance and efficiency.

• Stay updated with the latest advancements in analytical equipment, methodologies, and engineering practices.

• Ensure compliance with all relevant regulations and standards.

• Manage comprehensive equipment life cycle.

• Represent LP1on Global Lab Equipment Network.

• Adhere to global quality standards related to computer systems.

• Identify systemic issues affecting analytical testing in QC.

• Research and recommend new technologies.

• Serve as a technical mentor for Scientists and Technicians within and outside QC.

• Work with both internal and external organizations in instrument selection, usage, and troubleshooting.

• Coordinate with lab SMEs for procurement, set-up, and validation of lab equipment

• Create maintenance work instructions and establish engineering controls.

• Manage the drafting and review of cGMP documents.

• Manage/Develop maintenance strategies andauthor qualification protocols.

• Participate in self-assessments and regulatory inspections/audits.

• Provide technical review and Second Person Verification (SPV).

• Maintain and improve quality systems.

• Provide technical support to non-routine (e.g., observations) investigations including the preparation as required of relevant technical documents, such as: Change Controls, Analytical Investigations, Validation Protocols, Procedures and Quality System Management Review, etc.

Basic Requirements:

• Bachelor’s degree (chemistry or engineering is preferred) and 1+ year of experience in a GMP regulated environment OR

• 10+ years of experience managing maintenance, analytical equipment, or similar role in a GMP regulated environment

Additional Preferences:

• Experience in an engineering, maintenance, or technical support area.

• Recognized by others as having technical expertise of analytical equipment functionality.

• Demonstrate scientific and technical expertise.

• Teamwork and interpersonal skills.

• Decision making.

• Multi-tasking.

• Ability to prioritize.

• Complex instrumentation problem solving.

• Experience in a GMP/GLP environment

• Experience in troubleshooting and resolving equipment issues.

• Familiarity with various analytical techniques such as spectroscopy, chromatography, and mass spectrometry.

• Publications in peer-reviewed scientific journals.

• Experience in project management and leadership.

• Knowledge of engineering principles and practices related to analytical equipment.

• Strong knowledge of analytical principles, methodologies, and engineering practices.

• Excellent analytical and problem-solving skills.

• Ability to work independently and as part of a team.

• Strong communication and presentation skills.

• Proficiency in relevant scientific and engineering software and tools

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.

#WeAreLilly