LIMS Specialist

Description

• The company is focused on improving survival of people with cancer by harnessing the power of targeted radioisotopes and is developing innovative drugs against targets of solid tumors.
• Led by a successful and experienced entrepreneurial team, aims to be the global leader in radiopharmaceuticals.
• Reporting to the Sr. Manager of Quality Control, LIMS Specialist will be responsible for ensuring the laboratories at Indianapolis implementation and operation of Veeva LIMS system into Indianapolis manufacturing plant.
• Develop LIMS procedures for the laboratories and manufacturing, as needed; develop and maintain documentation for LIMS processes, user guides, and system validation.
• Maintain, configure, and troubleshoot the LIMS to support laboratory workflows and data integrity.
• Serve as the primary point of contact for LIMS-related issues in the laboratories and production, coordinating with IT and laboratory staff for timely resolution.
• Implement system updates, enhancements, and change controls in accordance with regulatory requirements (including, but not limited to, GxP, 21 CFR Part 11).
• Set up studies and sample management protocols in LIMS per laboratory and quality requirements.
• Provide user training and support to laboratory personnel, ensuring effective and compliant use of the LIMS.
• Participate in audits and inspections, providing LIMS data and documentation as required.
• Collaborate with cross-functional teams to support new laboratory initiatives and system integrations.
• Ensure data security, user access management, and backup procedures are in place and effective.
• Support laboratory business continuity and disaster recovery planning as it relates to LIMS.
  
  

Qualifications

• BS in Chemistry, Science, or relevant field with three to five years of experience in pharmaceutical or other cGMP experience. An advanced degree with less experience will be considered provided the LIMS experience requirement can be met.
• One to three years of experience with LIMS system, experience with Veeva LIMS strongly preferred. Experience with other modern LIMS systems preferred (i.e. Labware).
• Experience with injectable pharmaceuticals or radiopharmaceuticals strongly preferred
• Experience with HPLC, TLC, GC, Gamma Spec, and ICP preferred. Experience with at least some laboratory instruments required
• Highly motivated and organized professional with the ability to work independently or in a team environment
• Multi-disciplined scientist with GMP experience
• Experience with root cause techniques such as 6 M's, 5 Why's, fishbone, or similar preferred
• Very personable with strong communication skills
• Excellent professional ethics, integrity, and ability to maintain confidential information
• Must be comfortable working in a controlled environment with ionizing radiation and able to lift 40 lbs.
  
  

Benefits

Healthcare Insurance: Synectics offers eligible employees and their dependents healthcare coverage through BlueCross BlueShield of Illinois. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics. Premiums are subsidized by Synectics.

Dental Insurance: Synectics offers eligible employees and their dependents a dental plan through MetLife. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.

Vision Insurance: Synectics offers eligible employees vision insurance through VSP. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.401(k) Plan: The Synectics Inc. Investment Savings Retirement Plan. Synectics offers all employees who are 21 years of age or older the opportunity to invest in the 401(k) Plan on the first enrollment date that is at least 30 days after employment begins. Enrollment dates are each January 1st, April 1st, July 1st, and October 1st.

Technical Certification Bonus: Synectics is pleased to award its employees a bonus of up to $500 for an approved professional certification. In determining the bonus amount, Synectics will consider the cost of the test(s) for any certification relating to your current position, achieved during your employment with us. Only one Certification Bonus per calendar year may be awarded per employee. Only current, active employees will be eligible to receive this bonus. It will be awarded 90 days after the Synectics office has received documentation confirming the successful completion of the certification.

Synectics is an equal opportunity employer.