About the Role
Position Overview:
An advanced manufacturing facility is under construction in Lebanon, IN, focused on the production of API (Active Pharmaceutical Ingredient) molecules. This site represents a major investment in manufacturing capacity and will support both current and future pharmaceutical products, including new modalities.
This role offers a unique opportunity to contribute to the startup of a GMP manufacturing facility. The successful candidate will play a key role in developing the necessary processes, systems, and infrastructure to support technical operations and ensure long-term success.
Main Purpose and Objectives:
The TS/MS Flow Mentor is a critical member of the Technical Services/Manufacturing Science (TS/MS) team, providing expert leadership in developing and maintaining peptide and small molecule manufacturing strategies.
This position is integral to site startup, process implementation, and long-term operational excellence.
The Flow Mentor will lead technical initiatives to optimize process control, yield, purity, and productivity through experimental design, modeling, and data analysis. Responsibilities include the development of control strategies, process validation, and the implementation of advanced manufacturing technologies. The role also includes mentoring technical staff and building a culture of scientific rigor and continuous improvement.
During the startup phase, the role will require flexibility and adaptability, contributing to project execution, system design, organizational development, and culture building in a fast-evolving environment.
Key Responsibilities:
Serve as a technical mentor across disciplines, coaching frontline scientists in process understanding, problem solving, and project execution.
Lead and support investigations, providing technical expertise for quality, stability, and non-routine production issues.
Prepare, review, and approve technical documentation including Change Controls, Regulatory Submissions, Deviations, Validation protocols, Batch Production Records, SOPs, and process flows.
Manage and execute technical projects (experimental, modeling, data-driven) aimed at enhancing process performance and control.
Drive implementation of new manufacturing technologies and continuous improvement initiatives.
Develop and refine operational control strategies and validation protocols.
Provide oversight for the Post Launch Optimization Team (PLOT) and other cross-functional TS/MS initiatives.
Champion the use of statistical analysis and data-driven decision-making.
Own and manage the technical agenda for specific molecules or validation projects.
Collaborate across disciplines to ensure robust, compliant, and efficient manufacturing operations.
Requirements
Minimum Qualifications:
Bachelor’s degree in a STEM field (Chemistry preferred) with 5+ years of cGMP manufacturing experienceORMaster’s degree with 3+ years of relevant experience.
Direct experience supporting intermediate and/or drug substance manufacturing in a frontline technical capacity.
Preferred Qualifications:
Experience in related areas such as Quality Control, Quality Assurance, Procurement, Regulatory Affairs, or Project Management.
Expertise in small molecule, peptide, or oligonucleotide API manufacturing within a cGMP environment.
Demonstrated ability to lead cross-functional teams and technical projects.
Experience identifying and implementing process improvements.
Prior mentoring or leadership experience.
Adaptability to meet changing business demands.
About the Company
RepuCare, a certified Woman-Owned Business (WBE), is a leader in providing innovative workforce solutions. We have partnered with a global pharmaceutical client seeking a Technical Service/Manufacturing Science Flow Mentor to join their dynamic team. This is a hybrid role that combines in-office and remote work.