Principal Scientist, TSMS Cleaning Validation - ADN RAMP Team

Company: Initial Therapeutics, Inc.
Location: Indianapolis
Posted on: May 1, 2025

Job Description:

You will need to login before you can apply for a job.Principal Scientist, TSMS Cleaning Validation - ADN RAMP TeamAt 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 work worldwide to discover and deliver medicines that improve lives, understand and manage diseases, and support communities through philanthropy and volunteerism. We prioritize people and strive to make a difference.Organization OverviewAt Lilly, our purpose is extraordinary. We aim to make a difference globally by discovering, developing, and delivering medicines that help people live longer, healthier, and more active lives. We also develop innovative solutions to support communities through philanthropy and volunteerism.Position Brand Description:The Lilly API/Dry Product Network is expanding rapidly, with several new greenfield sites under construction to meet demand. These sites are staffed for full-scale, steady-state production, but additional surge capacity is needed for startup and ramp-up phases.The ADN RAMP (Rapid Access to Medicines for Patients) team is a cross-functional team bringing deep manufacturing expertise to support site startups through Operational Excellence, troubleshooting, problem-solving, and surge capacity. This role offers opportunities to work at new sites, expand the Lilly network, develop technical skills, and gain leadership experience through training and hands-on work. The team will also develop strategies to accelerate startup times at new Lilly sites, aligning with Lilly's mission to serve more patients.Success in this role involves supporting site startups through technical execution, coaching, collaboration, and developing local teams to operate independently.The team reports to their respective functional managers but is coordinated by the Ramp Team Sr. Director.Responsibilities include:

• Developing, implementing, and monitoring the Cleaning Program for new facilities, including creating a Cleaning Validation Master Plan based on benchmarking.
• Creating standardized procedures for Cleaning Assessments and training personnel.
• Standardizing cleaning procedures and instructions, ensuring critical information and parameters are included.
• Standardizing pre-start safety reviews involving EHS, Engineering, and Operations.
• Ensuring validation protocols and reports are standardized and technically sound.
• Developing cleaning metrics and supporting site reporting.
• Enhancing cleaning process efficiency and identifying improvement projects.
• Developing training programs for TSMS, Process Engineering, QA, and Operations teams on cleaning processes.
• Supporting cleaning activities during execution, attending and leading meetings as needed.
• Coordinating investigations related to cleaning, trending events, and driving improvements.
• Implementing industry benchmarking and trend analysis to improve the cleaning program.
• Ensuring compliance with GQS/Regulatory requirements related to Cleaning.Basic Requirements:
  • BSc in Chemistry, Biochemistry, or related science with 8-10 years of pharmaceutical manufacturing experience.
  • MSc in Chemistry, Biochemistry, or related science with at least 5 years of relevant industry experience.Additional Skills/Preferences:
    • Deep technical knowledge of Cleaning in Small Molecule, Peptide, or Biotech contexts.
    • Excellent communication skills, analytical and problem-solving abilities.
    • Collaborative and coaching skills, with the ability to influence without authority.
    • Ability to simplify complex issues and build trust with peers and leaders.
    • Willingness to work off-shift hours and travel as needed, including international relocations.Other Information:The ADN RAMP team supports multiple sites across the US and internationally. Travel and short-term assignments are expected. Lilly is committed to diversity and offers accommodations for applicants with disabilities. Equal opportunity employment is practiced.Employee resource groups (ERGs) are available for support and networking. Learn more about our groups.Compensation varies based on education, experience, skills, and location, with an anticipated range of $64,500 - $167,200. Additional benefits include bonuses, 401(k), health benefits, paid time off, and wellness programs. Lilly reserves the right to modify these programs.#WeAreLilly
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Keywords: Initial Therapeutics, Inc., Terre Haute , Principal Scientist, TSMS Cleaning Validation - ADN RAMP Team, Other , Indianapolis, Indiana