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Position Brand Description:

The TS/MS Flow Mentor is a frontline technical leadership position that develops and implements a technical agenda with the following primary objectives:

Reliable and compliant manufacturing of the API product(s).Improvement of the process control strategy and validation strategy, continuous optimization of the process chemistry, & implementation of new manufacturing technologies.Coaching and mentoring of frontline Scientists.Developing and sustaining scientific process knowledge.Driving process monitoring and prioritization of tasks

Key Objectives/Deliverables:

Serve as a technical mentor for Scientists, and other disciplines.Provide technical support to non-routine (e.g., deviation, process removal) investigations, including consultation on quality and stability issues. Prepare, review, and approve (as required) relevant technical documents, such as: Change Controls, Regulatory Submissions, Expert Opinions, Deviations, Validations, Batch Production Records, Procedures, PFDs, etc. Coordinate technical projects (experimental, modeling and/or production data analysis) to improve process control, yield, purity and/or productivity. Prepare Annual Product Reviews/Ongoing Process Verification ReportsLead and/or coordinate significant investigations.Lead development and implementation of new manufacturing technologies for the improvement of existing commercial manufacturing processes.Lead development and improvement of the operational control strategy.Provide project management coordination/oversight to the Post Launch Optimization Team (PLOT) and other relevant TS/MS technical projects.Coach and mentor frontline Scientists in aspects of fundamental TS/MS support including process understanding (both theoretical and practical), problem solving, and project management.Champion the application of statistical thinking and use of data to (a) monitor process performance and make science-based decisions, and (b) understand process variability and capability and drive improvements.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 back up and shutdown support for frontline Scientists.Perform and promote optimization of unit operation cycle time, loading, and yield performance.Lead prioritization and data monitoring meetingsOther duties as assigned

Basic Requirements:

Bachelor of Science degree (or equivalent experience) in engineering or the scientific discipline of Biochemistry, Protein Chemistry, Chemistry, Microbiology, or Pharmacy.5 years' work experience in an engineering or technical support area
 

Additional Preferences:

Additional relevant industrial experience in any of the following associated disciplines such as: API Manufacturing, Quality Control, Quality Assurance, advanced project management, regulatory, development, or administration is desirable.High-quality skills to include:Scientific knowledgeData analysisAbility to prioritizeAttention to detailsWritten and oral communicationCritical decision makingInterpersonal/people skillsComputer applicationsComplex problem solvingMentoring/leadershipSelf-motivationClear understanding of all cGMPs, policies, procedures, guidelines, and ensuring a fair/equitable/safe work environment.

Other Information:

No certifications required.Tasks require entering manufacturing areas which require wearing appropriate PPE.

The job specification is intended to provide a general overview of the job requirements at the time it was prepared.  The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job specification.  As always, you should consult with your supervision regarding your actual job responsibilities and any related duties that may be required for the position.

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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. Learn more about all of our groups.

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