Flow Mentor TSMS Specialist

2 weeks ago

Marquand, Missouri, United States Eli Lilly Full time
Job Title: Flow Mentor TSMS

At Eli Lilly, we are committed to making life better for people around the world. As a global healthcare leader, we are dedicated to discovering and bringing life-changing medicines to those who need them. We are seeking a highly skilled and experienced Flow Mentor TSMS to join our team.

Job Summary:

The Flow Mentor TSMS will be responsible for developing and implementing a technical agenda with the primary objectives of reliable and compliant manufacturing of API products, improvement of process control strategy and validation strategy, and coaching and mentoring of frontline scientists. The successful candidate will have a strong background in engineering or a scientific discipline, with experience in API manufacturing, quality control, and quality assurance.

Key Responsibilities:
  • Develop and implement a technical agenda to improve process control strategy and validation strategy
  • Coach and mentor frontline scientists in aspects of fundamental TS/MS support, including process understanding, problem-solving, and project management
  • Provide technical support to non-routine investigations, including consultation on quality and stability issues
  • Prepare, review, and approve relevant technical documents, such as change controls, regulatory submissions, and expert opinions
  • Lead and/or coordinate significant investigations and technical projects to improve process control, yield, purity, and/or productivity
  • Develop and improve the operational control strategy and lead the development and implementation of new manufacturing technologies
  • Provide project management coordination/oversight to the Post Launch Optimization Team (PLOT) and other relevant TS/MS technical projects
  • Champion the application of statistical thinking and use of data to monitor process performance and make science-based decisions
  • Own a technical agenda for a molecule or aspects of a molecule, or validation process
  • Promote and peer review documentation of learning points, technical studies, and event investigations
  • Provide backup and shutdown support for frontline scientists
  • Perform and promote optimization of unit operation cycle time, loading, and yield performance
  • Lead prioritization and data monitoring meetings
Requirements:
  • Bachelor of Science degree (or equivalent experience) in engineering or a scientific discipline
  • 5 years' work experience in an engineering or technical support area
Preferred Qualifications:
  • Additional relevant industrial experience in API manufacturing, quality control, quality assurance, advanced project management, regulatory, development, or administration
  • High-quality skills, including scientific knowledge, data analysis, ability to prioritize, attention to details, written and oral communication, critical decision-making, interpersonal/people skills, computer applications, complex problem-solving, mentoring/leadership, self-motivation, and clear understanding of all cGMPs, policies, procedures, guidelines, and ensuring a fair/equitable/safe work environment
Additional Information:

No certifications are required. Tasks require entering manufacturing areas, which require wearing appropriate PPE. 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 for further assistance.

Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, 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 help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women's Network, Working and Living with Disabilities.

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