This position is heavily LMS-focused. You will take ownership of the day-to-day training administration within our LMS (currently an object-oriented database. Veeva/LMS experience is a strong bonus). Your work will ensure the system runs efficiently, training records remain accurate, and all training transactions are executed consistently and in compliance with GxP expectations. You will build curriculum, set up scheduled classes, manage training...
Quality Control Associate Microbiologist Summary. The Quality Control Associate Microbiologist will work closely with the full Quality Control team, Quality Assurance and Manufacturing to develop and execute the microbiological testing of a wide variety of materials critical to and inclusive of the parenteral drug product manufacturing process. Such testing includes, but is not limited to: Bioburden, Endotoxin, Sterility, Hold-Time Studies, Hypot...
The Training & Design Specialist will balance strategic program development with hands-on training facilitation, helping drive the next stage of INCOG’s GxP Training Program. This includes shaping the program strategy, delivering onboarding and ongoing training, and collaborating with business leaders to align learning initiatives with operational goals. Key Responsibilities. Develop and implement the strategy for INCOG’s GxP Training Program, in...
The Quality Control Technician will be a member of the Quality Control Department. As a member of the team, he/she/they will be involved in routine QC sampling and testing of utilities, raw materials, in-process/finished product/stability drug product and incoming components in accordance with GMP (Good Manufacturing Practices) and safety guidelines. Technician will also support lab organization/operation by performing activities such as supply o...
Continuous Improvement Manager Summary. We are seeking a Continuous Improvement Manager with a passion for driving operational excellence and fostering a culture of continuous improvement across all functions of our organization. The Manager will be skilled in Lean Manufacturing, Six Sigma methodologies, and change management principles, with the ability to lead cross-functional teams through transformational projects. The Continuous Improvement ...
Senior Process Engineer, Automated Visual Inspection Summary. INCOG BioPharma is seeking a highly motivated individual with extensive capabilities in process engineering, manufacturing of injectable drug combination products and leading capital projects installing and qualifying automated visual inspection equipment. The ideal candidate must have experience in technical roles within biopharmaceutical based GXP manufacturing operations, including ...
The Quality Control Technician will be a member of the Quality Control Department. As a member of the team, he/she/they will be involved in routine QC sampling and testing of utilities, raw materials, in-process/finished product/stability drug product and incoming components in accordance with GMP (Good Manufacturing Practices) and safety guidelines. Technician will also support lab organization/operation by performing activities such as supply o...
The IT Infrastructure Manager is responsible for the strategic leadership, operational management, and continuous improvement of the organization’s IT infrastructure. Reporting directly to the Director of Information Technology, this role oversees the IT Systems Administration and Helpdesk teams, manages the relationship and performance of the Managed Service Provider (MSP), and ensures the reliability, security, and scalability of all IT infrast...
The Quality Control Technician will be a member of the Quality Control Department. As a member of the team, he/she/they will be involved in routine QC sampling and testing of utilities, raw materials, in-process/finished product/stability drug product and incoming components in accordance with GMP (Good Manufacturing Practices) and safety guidelines. Technician will also support lab organization/operation by performing activities such as supply o...
Description. INCOG is seeking a Quality Control (QC) Chemist with a passion for working within a team, a desire to drive Quality processes in a regulated setting, and a commitment to upholding the integrity of data generated for clients. The QC Chemist will work closely with the QC Chemistry Manager and Quality Control Method Transfer Scientists, as well as Project Management and Supply Chain teams, to support development, readiness, and routine ...
We are seeking an Enterprise Systems Technical Writer who is agile, collaborative, and passionate about technology and systems development. This role blends technical writing expertise with core business systems analysis skills. The Enterprise Systems Technical Writer will work closely with IT, Quality, Validation, and project teams to quickly learn new processes and systems, then translate that knowledge into clear, accurate documentation—includ...
Position Overview. The Senior Facilities Engineer (HVAC) will support the plant and clean utilities at INCOG BioPharma’s Fishers, Indiana location. The candidate will be the subject matter expert and system owner of all facility utilities, with a strong emphasis on HVAC systems that support GMP cleanroom manufacturing environments (Grade A–D) as well as the full suite of plant and clean utilities. Essential Job Functions. Provide engineering tech...
