Forge Biologics
Lead, GMP Manufacturing Support (Cleaning & Sanitization)
Forge Biologics, Grove City, Ohio, United States, 43123
Lead, GMP Manufacturing Support (Cleaning & Sanitization)
Grove City, Ohio Overview Forge Biologics is a GMP-focused gene therapy company operating in a state-of-the-art facility. This role leads and supports GMP cleanroom operations (ISO 5–8 / Grade A–D) and contamination control for viral vector production. The position oversees cleaning strategies, coordinates daily activities, and leads staff responsible for cleaning and GMP support. The ideal candidate has a strong understanding of aseptic practices, contamination control, and GMP regulations, along with leadership skills to promote compliance, safety, and operational excellence. What You’ll Do Lead the cleanroom cleaning team to perform routine and non-routine cleaning operations per SOPs and GMP requirements. Oversee cleaning of aseptic fill areas, upstream/downstream suites, airlocks, corridors, and equipment in accordance with validated procedures. Verify cleaning and sanitization activities and ensure accurate documentation; perform manufacturing review of logbooks and related documents; resolve out-of-trend situations promptly. Act as SME for cleanroom behaviors, gowning, and contamination control best practices. Support deviation investigations, root cause analysis, and CAPA development related to cleaning issues or contamination events. Plan and assign daily tasks for effective resource utilization, collaborate with planning, and maintain schedules. Train and coach staff on cleaning techniques, gowning, aseptic behavior, and cleanroom discipline. Collaborate with Manufacturing, Quality Assurance, Quality Control, Environmental Monitoring, and Facilities & Engineering to resolve issues and drive continuous improvement. Support cleaning validation and requalification activities for classified spaces and equipment. Manage cleanroom inventory to ensure availability of common-use items and uninterrupted operations. Oversee consumable expiration tracking and storage, implementing rotation protocols and guiding technicians to meet operational and regulatory standards. Support tubing sets preparation, process improvement initiatives, and collaborate with cross-functional teams to ensure efficient production of gene therapy products. May assist with regulatory inspections (FDA, EMA) as the subject matter expert for contamination control practices. What You’ll Bring Associate’s or Bachelor’s degree in a relevant scientific field (e.g., Biology, Chemistry, Engineering) or equivalent experience. Minimum 5 years of experience in a GMP manufacturing environment, preferably in biologics, gene therapy, or sterile manufacturing. Demonstrated leadership skills with experience overseeing or mentoring team members. Strong understanding of cleanroom classifications, contamination control principles, and GMP regulations. Experience working within a Quality Management System (QMS). Proven experience overseeing manufacturing support functions (e.g., cleaning and sanitization, tube set building and setup). Excellent communication, organization, and problem-solving skills. Strong computer skills, prior experience with manufacturing software (e.g., MRP or ERP), and ability to use data analytics to drive process improvements and results. Flexibility to work in shifts, including weekends and holidays as required by production schedules. Ability to work in classified cleanroom environments (ISO 5–8 / Grade A–D) while fully gowned in aseptic PPE. Able to lift up to 40 pounds and stand or walk for extended periods. Work Environment & Physical Requirements The work environment is fast-paced with a focus on compliance and safety. This role involves working in cleanroom environments with PPE and may require working in confined spaces. The job requires the ability to identify small details and distinguish colors as part of daily tasks. This job description is not a comprehensive listing of duties and responsibilities and may be updated as needed. Equal Opportunity Forge Biologics is an equal opportunity employer dedicated to building an inclusive and diverse workforce. Forge Biologics provides equal employment opportunities to all employees and applicants regardless of race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by law. Benefits Health, Dental, and Vision insurance that starts on day one with substantial premium coverage for employees and dependents Competitive PTO plus paid holidays Annual bonus for full-time employees 401(k) company match Fully stocked kitchen with free food and drinks Onsite gym 12 weeks of paid parental leave and additional support programs Employee Assistance Program Wellness benefits including financial planning and mental health support
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Grove City, Ohio Overview Forge Biologics is a GMP-focused gene therapy company operating in a state-of-the-art facility. This role leads and supports GMP cleanroom operations (ISO 5–8 / Grade A–D) and contamination control for viral vector production. The position oversees cleaning strategies, coordinates daily activities, and leads staff responsible for cleaning and GMP support. The ideal candidate has a strong understanding of aseptic practices, contamination control, and GMP regulations, along with leadership skills to promote compliance, safety, and operational excellence. What You’ll Do Lead the cleanroom cleaning team to perform routine and non-routine cleaning operations per SOPs and GMP requirements. Oversee cleaning of aseptic fill areas, upstream/downstream suites, airlocks, corridors, and equipment in accordance with validated procedures. Verify cleaning and sanitization activities and ensure accurate documentation; perform manufacturing review of logbooks and related documents; resolve out-of-trend situations promptly. Act as SME for cleanroom behaviors, gowning, and contamination control best practices. Support deviation investigations, root cause analysis, and CAPA development related to cleaning issues or contamination events. Plan and assign daily tasks for effective resource utilization, collaborate with planning, and maintain schedules. Train and coach staff on cleaning techniques, gowning, aseptic behavior, and cleanroom discipline. Collaborate with Manufacturing, Quality Assurance, Quality Control, Environmental Monitoring, and Facilities & Engineering to resolve issues and drive continuous improvement. Support cleaning validation and requalification activities for classified spaces and equipment. Manage cleanroom inventory to ensure availability of common-use items and uninterrupted operations. Oversee consumable expiration tracking and storage, implementing rotation protocols and guiding technicians to meet operational and regulatory standards. Support tubing sets preparation, process improvement initiatives, and collaborate with cross-functional teams to ensure efficient production of gene therapy products. May assist with regulatory inspections (FDA, EMA) as the subject matter expert for contamination control practices. What You’ll Bring Associate’s or Bachelor’s degree in a relevant scientific field (e.g., Biology, Chemistry, Engineering) or equivalent experience. Minimum 5 years of experience in a GMP manufacturing environment, preferably in biologics, gene therapy, or sterile manufacturing. Demonstrated leadership skills with experience overseeing or mentoring team members. Strong understanding of cleanroom classifications, contamination control principles, and GMP regulations. Experience working within a Quality Management System (QMS). Proven experience overseeing manufacturing support functions (e.g., cleaning and sanitization, tube set building and setup). Excellent communication, organization, and problem-solving skills. Strong computer skills, prior experience with manufacturing software (e.g., MRP or ERP), and ability to use data analytics to drive process improvements and results. Flexibility to work in shifts, including weekends and holidays as required by production schedules. Ability to work in classified cleanroom environments (ISO 5–8 / Grade A–D) while fully gowned in aseptic PPE. Able to lift up to 40 pounds and stand or walk for extended periods. Work Environment & Physical Requirements The work environment is fast-paced with a focus on compliance and safety. This role involves working in cleanroom environments with PPE and may require working in confined spaces. The job requires the ability to identify small details and distinguish colors as part of daily tasks. This job description is not a comprehensive listing of duties and responsibilities and may be updated as needed. Equal Opportunity Forge Biologics is an equal opportunity employer dedicated to building an inclusive and diverse workforce. Forge Biologics provides equal employment opportunities to all employees and applicants regardless of race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by law. Benefits Health, Dental, and Vision insurance that starts on day one with substantial premium coverage for employees and dependents Competitive PTO plus paid holidays Annual bonus for full-time employees 401(k) company match Fully stocked kitchen with free food and drinks Onsite gym 12 weeks of paid parental leave and additional support programs Employee Assistance Program Wellness benefits including financial planning and mental health support
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