{"schemaVersion":"jobsearcher.job.v1","id":"6c2e716e3413712cbd555e75","url":"https://jobsearcher.com/jobs/6c2e716e3413712cbd555e75","canonicalUrl":"https://jobsearcher.com/jobs/6c2e716e3413712cbd555e75","title":"Production Manager","description":"Job Description: Production Manager\nTitle: Production Manager\nDepartment: Radiopharmaceutical Contract Manufacturing\nTraining Curriculum: ID TCU.XXX\n\nOverview:\nThe Production Manager for Radiopharmaceutical Contract Manufacturing is responsible for\noverseeing the Pharmaceutical Production Chemists and Aseptic Cleaning Technicians, ensuring timely manufacture and\ndelivery of all diagnostic and therapeutic radiopharmaceutical finished product to meet customer expectations. The\nProduction Manager will be responsible for overseeing the site’s production related activities within aseptic and GMP\nareas such as cleaning, manufacturing campaigns for various products, and coordinating/scheduling both resources and\nmaterials for production. Following SOFIE's master records, SOPs, and QMS requirements, and following cGMP\nguidelines, the Production Manager will ensure that these radiopharmaceuticals are in full compliance with all regulatory\nrequirements, including 21 CFR 211/212, EudraLex Volume 4, and all other applicable regulations for drug manufacturing.\nEssential Duties and Responsibilities\n\nLead and implement the transfer of established manufacturing processes, records, and procedures for new\nradiopharmaceuticals, either directly from customer or from SOFIE development group, or the SOFIE production\nteam.\n\nSchedule and supervise clinical and commercial manufacturing activities, focusing on full compliance with industry\nrequirements. Lead by example by fully understanding and participating in manufacturing activities as needed.\n\nManage implementation, validation, organization, and participation in the production of routine patient dose\nmanufacturing activities for various radiopharmaceutical drug products.\n\nManage and supervise the RCM production and cleaning team (including shift leads and supervisors) beginning\nwith the transition of radiopharmaceuticals in development to clinical manufacturing and through commercial\nmanufacturing.\n\nConduct performance review for the direct reports and or indirect reports as assigned. Track performance through\nregular 1:1s and staff meetings.\n\nDevelops and maintains working relationships with employees at all levels. Manage current and newly hired\npersonnel training process and ensures training for direct reports meets expectations as defined in job specific\ntraining matrices.Ensure aseptic operations by the production team members comply with internal procedures (example: gowning,\ncleaning/sanitation, sterility, environmental monitoring), accepted industry practice and regulatory guidance.\nAssure completeness, accuracy, traceability, and compliance of the site utility and facility monitoring methods and\nrecords. Provide support to site Microbiologists and QA, as necessary.\n\nReview and approve clinical dose manufacturing plans, final drug product labels, reagents, manufacturing batch\nrecords, and associated EM data. Properly organize and securely maintain cGMP production documents until\narchived by QA. Keep facility and manufacturing SOPs up to date and ensure no copies of obsoleted documents\nare held by the production team members.\n\nWork with SOFIE's QA, Regulatory, and EH&S teams to ensure SOFIE's standards are continuously reflected in\nall new radiopharmaceutical products and contribute in the generation of regulatory documentation required for\nnew radiopharmaceuticals, including Standard Operating Procedures (SOPs), development and validation\nProtocols, and Master Batch Records.\n\nOversee the participation of the production team in the installation, qualification, and maintenance of the facility\nproduction equipment. Executes approved protocols to validate manufacturing processes in coordination with\nproject managers. Maintain individual qualification requirements and training for entering ISO classified areas.\n\nDemonstrate proficiency in industry radiation safety procedures. Responsible for tracking radiation exposure of\nproduction personnel and seeing that principles of ALARA are maintained. Maintain a clean and safe working\nenvironment and perform radiation safety duties in compliance with safety and pharmaceutical regulations.\n\nProvide oversight to the materials utilized in the manufacturing process and ensure that raw materials,\ncomponents, containers, closures, packaging, and labeling are inspected, qualified, and meet acceptance criteria\nbefore use.\n\nLead exception document initiation and investigation for manufacturing processes [Deviation, OOS, Action/Alert\nLevel Notifications]. Ensure that scientifically sound root causes are identified. Initiate and Implement CAPA plans. Evaluate effectiveness of the CAPA plans through reporting and trending. Ensure SOFIE's Change Control\nprocedure is followed as required.\n\nMonitor site production performance and manage departmental metrics by collecting key performance indicators.\nCollaborate cross functionally to discuss operations, issues/concerns, innovative ideas, and continuous quality\nimprovements. Keep departmental costs within the budget and determine ways to reduce production costs using\nLean tools.\n\nAbility to work various shifts and weekends required. Perform routine production synthesis as needed.\nWrite reports, presentations, and other documentation summarizing data. Coordinate the Radiopharmaceutical\nContract Manufacturing team's activities to reach defined objectives.\n\nLiaise with our contract partners (e.g., biotech and pharma). Effectively communicate with customers, vendors,\nand other internal sites.\n\nPerform other duties as assigned.\nQualifications:\nBachelor’s degree in a scientific field is required with 10+ years of experience in radiopharmaceutical /\npharmaceutical drug product manufacturing and production equipment management (qualification,\ntroubleshooting and maintenance) required. Master’s degree with 7+ years of experience is preferred.\n\nThree to five years of people management experience required.\nFamiliarity with radiation protection and safe handling of radioactive materials is required. Experience in radiation\nsafety is highly preferred.\n\nAbility to read and interpret documents such as safety rules, operating and maintenance instructions, and\nprocedure manuals required.\n\nExperience in cGMP manufacturing environment is highly preferred. Knowledge of cGMP requirements, aseptic\nprocess (cleanroom environment), and equipment qualification is required.\n\nEfficient in the use of MS Office Suite required.\nExcellent organizational skills required. Knowledge of Lean Six Sigma preferred.\nCross functional communication skills in addition to collaboration and troubleshooting","company":"Sofie","rawCompany":"sofie","city":"Gilroy","state":"CA","isRemote":false,"isActive":false,"createdAt":"2026-05-06T05:55:04.958Z","occupations":[{"code":"11-3051.00","title":"Industrial Production Managers","slug":"industrial-production-managers"},{"code":"51-1011.00","title":"First-Line Supervisors of Production and Operating Workers","slug":"first-line-supervisors-of-production-and-operating-workers"},{"code":"11-3051.01","title":"Quality Control Systems Managers","slug":"quality-control-systems-managers"}],"industries":[{"code":"325412","title":"Pharmaceutical Preparation Manufacturing","slug":"pharmaceutical-preparation-manufacturing"},{"code":"325414","title":"Biological Product (except Diagnostic) Manufacturing","slug":"biological-product-except-diagnostic-manufacturing"},{"code":"325411","title":"Medicinal and Botanical Manufacturing","slug":"medicinal-and-botanical-manufacturing"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"Production Manager","description":"Job Description: Production Manager\nTitle: Production Manager\nDepartment: Radiopharmaceutical Contract Manufacturing\nTraining Curriculum: ID TCU.XXX\n\nOverview:\nThe Production Manager for Radiopharmaceutical Contract Manufacturing is responsible for\noverseeing the Pharmaceutical Production Chemists and Aseptic Cleaning Technicians, ensuring timely manufacture and\ndelivery of all diagnostic and therapeutic radiopharmaceutical finished product to meet customer expectations. The\nProduction Manager will be responsible for overseeing the site’s production related activities within aseptic and GMP\nareas such as cleaning, manufacturing campaigns for various products, and coordinating/scheduling both resources and\nmaterials for production. Following SOFIE's master records, SOPs, and QMS requirements, and following cGMP\nguidelines, the Production Manager will ensure that these radiopharmaceuticals are in full compliance with all regulatory\nrequirements, including 21 CFR 211/212, EudraLex Volume 4, and all other applicable regulations for drug manufacturing.\nEssential Duties and Responsibilities\n\nLead and implement the transfer of established manufacturing processes, records, and procedures for new\nradiopharmaceuticals, either directly from customer or from SOFIE development group, or the SOFIE production\nteam.\n\nSchedule and supervise clinical and commercial manufacturing activities, focusing on full compliance with industry\nrequirements. Lead by example by fully understanding and participating in manufacturing activities as needed.\n\nManage implementation, validation, organization, and participation in the production of routine patient dose\nmanufacturing activities for various radiopharmaceutical drug products.\n\nManage and supervise the RCM production and cleaning team (including shift leads and supervisors) beginning\nwith the transition of radiopharmaceuticals in development to clinical manufacturing and through commercial\nmanufacturing.\n\nConduct performance review for the direct reports and or indirect reports as assigned. Track performance through\nregular 1:1s and staff meetings.\n\nDevelops and maintains working relationships with employees at all levels. Manage current and newly hired\npersonnel training process and ensures training for direct reports meets expectations as defined in job specific\ntraining matrices.Ensure aseptic operations by the production team members comply with internal procedures (example: gowning,\ncleaning/sanitation, sterility, environmental monitoring), accepted industry practice and regulatory guidance.\nAssure completeness, accuracy, traceability, and compliance of the site utility and facility monitoring methods and\nrecords. Provide support to site Microbiologists and QA, as necessary.\n\nReview and approve clinical dose manufacturing plans, final drug product labels, reagents, manufacturing batch\nrecords, and associated EM data. Properly organize and securely maintain cGMP production documents until\narchived by QA. Keep facility and manufacturing SOPs up to date and ensure no copies of obsoleted documents\nare held by the production team members.\n\nWork with SOFIE's QA, Regulatory, and EH&S teams to ensure SOFIE's standards are continuously reflected in\nall new radiopharmaceutical products and contribute in the generation of regulatory documentation required for\nnew radiopharmaceuticals, including Standard Operating Procedures (SOPs), development and validation\nProtocols, and Master Batch Records.\n\nOversee the participation of the production team in the installation, qualification, and maintenance of the facility\nproduction equipment. Executes approved protocols to validate manufacturing processes in coordination with\nproject managers. Maintain individual qualification requirements and training for entering ISO classified areas.\n\nDemonstrate proficiency in industry radiation safety procedures. Responsible for tracking radiation exposure of\nproduction personnel and seeing that principles of ALARA are maintained. Maintain a clean and safe working\nenvironment and perform radiation safety duties in compliance with safety and pharmaceutical regulations.\n\nProvide oversight to the materials utilized in the manufacturing process and ensure that raw materials,\ncomponents, containers, closures, packaging, and labeling are inspected, qualified, and meet acceptance criteria\nbefore use.\n\nLead exception document initiation and investigation for manufacturing processes [Deviation, OOS, Action/Alert\nLevel Notifications]. Ensure that scientifically sound root causes are identified. Initiate and Implement CAPA plans. Evaluate effectiveness of the CAPA plans through reporting and trending. Ensure SOFIE's Change Control\nprocedure is followed as required.\n\nMonitor site production performance and manage departmental metrics by collecting key performance indicators.\nCollaborate cross functionally to discuss operations, issues/concerns, innovative ideas, and continuous quality\nimprovements. Keep departmental costs within the budget and determine ways to reduce production costs using\nLean tools.\n\nAbility to work various shifts and weekends required. Perform routine production synthesis as needed.\nWrite reports, presentations, and other documentation summarizing data. Coordinate the Radiopharmaceutical\nContract Manufacturing team's activities to reach defined objectives.\n\nLiaise with our contract partners (e.g., biotech and pharma). Effectively communicate with customers, vendors,\nand other internal sites.\n\nPerform other duties as assigned.\nQualifications:\nBachelor’s degree in a scientific field is required with 10+ years of experience in radiopharmaceutical /\npharmaceutical drug product manufacturing and production equipment management (qualification,\ntroubleshooting and maintenance) required. Master’s degree with 7+ years of experience is preferred.\n\nThree to five years of people management experience required.\nFamiliarity with radiation protection and safe handling of radioactive materials is required. Experience in radiation\nsafety is highly preferred.\n\nAbility to read and interpret documents such as safety rules, operating and maintenance instructions, and\nprocedure manuals required.\n\nExperience in cGMP manufacturing environment is highly preferred. Knowledge of cGMP requirements, aseptic\nprocess (cleanroom environment), and equipment qualification is required.\n\nEfficient in the use of MS Office Suite required.\nExcellent organizational skills required. Knowledge of Lean Six Sigma preferred.\nCross functional communication skills in addition to collaboration and troubleshooting","datePosted":"2026-05-06T05:55:04.958Z","dateModified":"2026-05-06T05:55:04.958Z","hiringOrganization":{"@type":"Organization","name":"Sofie","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Gilroy","addressRegion":"CA","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"6c2e716e3413712cbd555e75"},"url":"https://jobsearcher.com/jobs/6c2e716e3413712cbd555e75"}}