Scientist - QC

Initial Therapeutics, Inc.; Lebanon (IN); On-site; USD 50,000 - 85,000; Full time

Job summary

An established industry player seeks a dedicated Scientist-QC to join its new manufacturing facility in Lebanon, IN. This exciting role involves providing technical leadership in Quality Control, ensuring compliance with GMP standards, and performing critical lab analyses. As part of a pioneering startup team, you'll contribute to the development and implementation of quality systems while driving continuous improvement initiatives. If you thrive in a dynamic lab environment and are passionate about making a difference in healthcare, this opportunity is perfect for you!

Benefits

Short-term assignment potential at Indianapolis facilities

Overtime opportunities

Safety gear provided

Qualifications

• 1+ years of experience in a cGMP laboratory environment.
• Bachelor's degree in Chemistry, Biology, or Microbiology.

Responsibilities

• Perform accurate testing of lab samples following GMP guidelines.
• Participate in root cause investigations and quality system improvements.

Skills

Analytical Skills

Problem Solving

Strong Communication Skills

Documentation Skills

Education

Bachelor's degree in a science field

Tools

LIMS

CDS

Microsoft Office Suite

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.

Organization Overview:

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

Position Description:

The Scientist-QC is part of the Lilly Lebanon API Quality Control team and provides technical leadership and expertise in the development, implementation, and maintenance of Quality Control laboratory systems to the Lilly Lebanon API site throughout the start-up, implementation, and day to day operations.

The Scientist-QC performs accurate and timely testing of routine and some non-routine lab samples in accordance with appropriate GMP and safety guidelines. The Scientist completes second person verification of other’s results. The Scientist also participates in laboratory root cause investigations, equipment evaluations and qualifications, and some quality system improvement initiatives by executing well-defined protocols and procedures. The Scientist shares technical information and best practice within plant sites or group.

In addition, the Scientist-QC will provide technical support to QC operations as part of the organization’s off-hours support strategy.

Key Objectives/Deliverables:

Sample Analysis and Reporting

• Verify (SPV) analytical data of other analysts within the lab as requested
• Accurately and safely perform analytical test methods or related support activities as per procedures or protocols. Uses technical knowledge in the review and interpretation of data for conformances to procedures, standards and protocols and/or real-time recognition of aberrant data and results
• Perform data entry and reviews own work for accuracy in accordance with laboratory procedures, standards and GMP requirements

Problem Solving

• Recognizes when a deviation from protocols, procedures, etc. has occurred and initiates and participates in a Root Cause Investigation
• Performs investigations for deviations
• Troubleshoot equipment and methods as required

Continuous Improvement Initiatives

• Assist in improvement of quality systems by creating or revising workflows and other lab data collection systems
• Follow Lilly standards for CCI/Lean and support/lead departmental or site continuous improvement initiatives
• Participate and/or lead laboratory projects in adherence to Lean OpEx standards
• Contributes to development of PQEs
• Reviews SOPs for executable as written
• Shares technical information and best practice within plant sites or group

Lab Operations

• Write protocols for non-routine testing or validation with appropriate guidance
• Develop equipment qualification protocols with appropriate guidance
• Perform routine equipment calibrations or maintenance
• Comply with and implement safety standards
• Execute notification to management when required by procedures or standards
• Initiate change controls and deviations
• Train and mentor others.
• Develop training materials

Basic Requirements:

• Bachelor’s degree (4-yr College) in a science field related to the lab (e.g., Chemistry, Biology, Microbiology, etc.)
• 1+ years of experience within a cGMP laboratory environment.

Additional Preferences

• Ability to work in a lab environment, including wearing appropriate PPE and other safety required equipment and considerations
• Demonstrate strong math and documentation skills
• Demonstrate strong oral and written communication and interpersonal interaction skills
• Proficiency with computer systems LIMS, CDS, Microsoft Office Suite, etc.
• Previous experience with cGMP deviation and change control process

Other Information:

• Strong potential for a short-term assignment at one of our Indianapolis-based manufacturing facilities.
• Tasks may require repetitive motion and standing for long periods of time
• Must be able to lift at least 5 liters of liquid
• Role may be in support of 24-hour operations, requiring shifts that cover days, nights, and weekends
• Overtime or weekend work required, as necessary