Manufacturing & Technical Operations Manager Catachem, Inc. — Oxford, CT Full-time |

On-site Salary:

$90,000-$110,000 per year, based on experience Reports to:

General Manager Benefits:

Information upon request. About the Role Catachem, Inc. is seeking a Manufacturing & Technical Operations Manager to lead day-to-day manufacturing and technical operations at our Oxford, Connecticut facility. This is a hands-on leadership role combining manufacturing, applied chemistry, technical problem-solving and people management. The Manager will oversee production of diagnostic reagents and related products, supervise manufacturing and technical personnel, troubleshoot production and product-performance issues, and support technology transfer and new-product introduction. Reporting directly to the General Manager, this individual will be expected to understand what is happening across laboratory and manufacturing operations, identify potential issues early, make routine operational decisions independently, and escalate significant issues with clear recommendations. This position is ideal for an experienced scientist, manufacturing professional or technical lead who is ready to take on broader manufacturing and leadership responsibility while remaining technically involved. What You'll Do Manufacturing & Technical Operations Plan, prioritize and supervise daily manufacturing of diagnostic reagents, calibrators, controls, buffers, diluents, biological matrices and related products. Oversee solution preparation, weighing, compounding, mixing, pH adjustment, filtration, filling, lyophilization, packaging, labeling and kitting. Participate directly in laboratory and manufacturing activities when needed for production, training, troubleshooting or process development. Verify formulas, concentrations, dilutions, scale-up calculations, raw-material quantities, yields and fill volumes. Ensure manufacturing activities and batch records are accurate, complete and performed according to approved procedures. Coordinate personnel, equipment, materials and supplies to meet production schedules and quality requirements. Review manufacturing and laboratory data and troubleshoot formulation, filtration, filling, lyophilization, stability, contamination and product-performance issues. Support equipment maintenance, calibration and qualification, cleanroom operations, inventory planning and evaluation of alternate materials and suppliers. Technology Transfer & Product Development Support the transfer of new and existing products and processes into routine manufacturing. Review formulas, specifications and process requirements to identify manufacturing requirements and potential scale-up risks. Convert approved processes into controlled formulas, batch records, work instructions and manufacturing workflows. Plan and execute feasibility, pilot, engineering and validation batches. Support process scale-up, optimization and validation. Prepare technical reports, transfer documentation and batch summaries. Support assigned new-product development and introduction activities. Quality & Compliance Ensure manufacturing activities are performed in accordance with approved procedures and Catachem's

ISO 13485

quality management system. Maintain appropriate documentation, traceability and data integrity. Support deviations, nonconformances, investigations, CAPAs, change controls, risk assessments, validation and audit activities. Work closely with Quality to investigate and resolve manufacturing and technical issues. Provide technical information and documentation to support regulatory activities as needed. Leadership & Operations Supervise, train and provide technical guidance to manufacturing and technical personnel. Assign and prioritize work and monitor employee competency and performance. Identify personnel, equipment, material, technical and scheduling issues that may affect operations. Identify opportunities to improve workflow, documentation, yield, capacity and process consistency. Provide the General Manager with production updates, technical assessments, resource needs and recommendations. Independently address routine operational issues within established procedures and delegated authority. Provide technical support to customers and internal teams as needed. Assist in evaluating new technical opportunities and manufacturing feasibility. Required Qualifications Bachelor's degree or higher in Chemistry, Biochemistry, Biotechnology, Pharmaceutical Sciences, Chemical Engineering, Biological Sciences or a related scientific discipline. 5+ years of relevant industry experience in diagnostics, medical devices, pharmaceuticals, biotechnology or another regulated manufacturing environment. Hands-on laboratory or manufacturing experience involving solution preparation, formulation, mixing, pH adjustment, filtration, filling or similar processes. Working knowledge of manufacturing calculations, including concentrations, dilutions, yields and scale-up calculations. Experience working within

ISO 13485, FDA

GMP or another regulated quality system . Experience leading personnel, production activities or significant technical projects. Strong technical troubleshooting and problem-solving skills. Ability to manage multiple projects and priorities. Strong written and verbal communication skills. Willingness to remain hands-on in laboratory and manufacturing activities when needed. Preferred Experience — Not Required on Day One You do not need experience in every area below to be considered. Catachem will provide training on company-specific products, processes, equipment and procedures. Experience in one or more of the following is preferred: Diagnostic or IVD reagent manufacturing Clinical chemistry, calibrators or controls Proteins, enzymes or biological matrices Lyophilization Technology transfer or process scale-up Process or equipment validation CAPA, deviations or change control Cleanroom manufacturing Product development Clinical chemistry analyzers Customer technical support M.S. or Ph.D. in a related scientific discipline is preferred but not required.

Pay:

$90,000.00 - $110,000.00 per year

Benefits:

Dental insurance Flexible schedule Health insurance Paid time off

Work Location:

In person