SOFIE
Production Manager
SOFIE, Totowa, New Jersey, us, 07512
Job Description: Production Manager, Radiopharmaceutical Contract Manufacturing, NJ5
Scroll down the page to see all associated job requirements, and any responsibilities successful candidates can expect.Title: Production ManagerLocation: NJ5-Totowa, New JerseyDepartment: Radiopharmaceutical Contract ManufacturingTraining Curriculum: ID TCU.XXX
Overview:
The Production Manager for Radiopharmaceutical Contract Manufacturing at NJ5 is responsible foroverseeing the Pharmaceutical Production Chemists and Aseptic Cleaning Technicians, ensuring timely manufacture anddelivery of all diagnostic and therapeutic radiopharmaceutical finished product to meet customer expectations. TheProduction Manager will be responsible for overseeing the site’s production related activities within aseptic and GMPareas such as cleaning, manufacturing campaigns for various products, and coordinating/scheduling both resources andmaterials for production. Following SOFIE's master records, SOPs, and QMS requirements, and following cGMPguidelines, the Production Manager will ensure that these radiopharmaceuticals are in full compliance with all regulatoryrequirements, including 21 CFR 211/212, EudraLex Volume 4, and all other applicable regulations for drug manufacturing.Essential Duties and Responsibilities▪ Lead and implement the transfer of established manufacturing processes, records, and procedures for newradiopharmaceuticals, either directly from customer or from SOFIE development group, or the SOFIE productionteam.▪ Schedule and supervise clinical and commercial manufacturing activities, focusing on full compliance with industryrequirements. Lead by example by fully understanding and participating in manufacturing activities as needed.▪ Manage implementation, validation, organization, and participation in the production of routine patient dosemanufacturing activities for various radiopharmaceutical drug products.▪ Manage and supervise the RCM production and cleaning team (including shift leads and supervisors) beginningwith the transition of radiopharmaceuticals in development to clinical manufacturing and through commercialmanufacturing.▪ Conduct performance review for the direct reports and or indirect reports as assigned. Track performance throughregular 1:1s and staff meetings.▪ Develops and maintains working relationships with employees at all levels. Manage current and newly hiredpersonnel training process and ensures training for direct reports meets expectations as defined in job specifictraining matrices.Ensure aseptic operations by the production team members comply with internal procedures (example: gowning,cleaning/sanitation, sterility, environmental monitoring), accepted industry practice and regulatory guidance.Assure completeness, accuracy, traceability, and compliance of the site utility and facility monitoring methods andrecords. Provide support to site Microbiologists and QA, as necessary.▪ Review and approve clinical dose manufacturing plans, final drug product labels, reagents, manufacturing batchrecords, and associated EM data. Properly organize and securely maintain cGMP production documents untilarchived by QA. Keep facility and manufacturing SOPs up to date and ensure no copies of obsoleted documentsare held by the production team members.▪ Work with SOFIE's QA, Regulatory, and EH&S teams to ensure SOFIE's standards are continuously reflected inall new radiopharmaceutical products and contribute in the generation of regulatory documentation required fornew radiopharmaceuticals, including Standard Operating Procedures (SOPs), development and validationProtocols, and Master Batch Records.▪ Oversee the participation of the production team in the installation, qualification, and maintenance of the facilityproduction equipment. Executes approved protocols to validate manufacturing processes in coordination withproject managers. Maintain individual qualification requirements and training for entering ISO classified areas.▪ Demonstrate proficiency in industry radiation safety procedures. Responsible for tracking radiation exposure ofproduction personnel and seeing that principles of ALARA are maintained. Maintain a clean and safe workingenvironment and perform radiation safety duties in compliance with safety and pharmaceutical regulations.▪ Provide oversight to the materials utilized in the manufacturing process and ensure that raw materials,components, containers, closures, packaging, and labeling are inspected, qualified, and meet acceptance criteriabefore use.▪ Lead exception document initiation and investigation for manufacturing processes [Deviation, OOS, Action/AlertLevel 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 Controlprocedure is followed as required.▪ Monitor site production performance and manage departmental metrics by collecting key performance indicators.Collaborate cross functionally to discuss operations, issues/concerns, innovative ideas, and continuous qualityimprovements. Keep departmental costs within the budget and determine ways to reduce production costs usingLean tools.▪ Ability to work various shifts and weekends required. Perform routine production synthesis as needed.▪ Write reports, presentations, and other documentation summarizing data. Coordinate the RadiopharmaceuticalContract Manufacturing team's activities to reach defined objectives.▪ Liaise with our contract partners (e.g., biotech and pharma). Effectively communicate with customers, vendors,and other internal sites.▪ Perform other duties as assigned.
Qualifications:
▪ Bachelor’s degree in a scientific field is required with 10+ years of experience in radiopharmaceutical /pharmaceutical drug product manufacturing and production equipment management (qualification,troubleshooting and maintenance) required. Master’s degree with 7+ years of experience is preferred.▪ Three to five years of people management experience required.▪ Familiarity with radiation protection and safe handling of radioactive materials is required. Experience in radiationsafety is highly preferred.▪ Ability to read and interpret documents such as safety rules, operating and maintenance instructions, andprocedure manuals required.▪ Experience in cGMP manufacturing environment is highly preferred. Knowledge of cGMP requirements, asepticprocess (cleanroom environment), and equipment qualification is required.▪ Efficient in the use of MS Office Suite required.▪ Excellent organizational skills required. Knowledge of Lean Six Sigma preferred.▪ Cross functional communication skills in addition to collaboration and troubleshooting
Scroll down the page to see all associated job requirements, and any responsibilities successful candidates can expect.Title: Production ManagerLocation: NJ5-Totowa, New JerseyDepartment: Radiopharmaceutical Contract ManufacturingTraining Curriculum: ID TCU.XXX
Overview:
The Production Manager for Radiopharmaceutical Contract Manufacturing at NJ5 is responsible foroverseeing the Pharmaceutical Production Chemists and Aseptic Cleaning Technicians, ensuring timely manufacture anddelivery of all diagnostic and therapeutic radiopharmaceutical finished product to meet customer expectations. TheProduction Manager will be responsible for overseeing the site’s production related activities within aseptic and GMPareas such as cleaning, manufacturing campaigns for various products, and coordinating/scheduling both resources andmaterials for production. Following SOFIE's master records, SOPs, and QMS requirements, and following cGMPguidelines, the Production Manager will ensure that these radiopharmaceuticals are in full compliance with all regulatoryrequirements, including 21 CFR 211/212, EudraLex Volume 4, and all other applicable regulations for drug manufacturing.Essential Duties and Responsibilities▪ Lead and implement the transfer of established manufacturing processes, records, and procedures for newradiopharmaceuticals, either directly from customer or from SOFIE development group, or the SOFIE productionteam.▪ Schedule and supervise clinical and commercial manufacturing activities, focusing on full compliance with industryrequirements. Lead by example by fully understanding and participating in manufacturing activities as needed.▪ Manage implementation, validation, organization, and participation in the production of routine patient dosemanufacturing activities for various radiopharmaceutical drug products.▪ Manage and supervise the RCM production and cleaning team (including shift leads and supervisors) beginningwith the transition of radiopharmaceuticals in development to clinical manufacturing and through commercialmanufacturing.▪ Conduct performance review for the direct reports and or indirect reports as assigned. Track performance throughregular 1:1s and staff meetings.▪ Develops and maintains working relationships with employees at all levels. Manage current and newly hiredpersonnel training process and ensures training for direct reports meets expectations as defined in job specifictraining matrices.Ensure aseptic operations by the production team members comply with internal procedures (example: gowning,cleaning/sanitation, sterility, environmental monitoring), accepted industry practice and regulatory guidance.Assure completeness, accuracy, traceability, and compliance of the site utility and facility monitoring methods andrecords. Provide support to site Microbiologists and QA, as necessary.▪ Review and approve clinical dose manufacturing plans, final drug product labels, reagents, manufacturing batchrecords, and associated EM data. Properly organize and securely maintain cGMP production documents untilarchived by QA. Keep facility and manufacturing SOPs up to date and ensure no copies of obsoleted documentsare held by the production team members.▪ Work with SOFIE's QA, Regulatory, and EH&S teams to ensure SOFIE's standards are continuously reflected inall new radiopharmaceutical products and contribute in the generation of regulatory documentation required fornew radiopharmaceuticals, including Standard Operating Procedures (SOPs), development and validationProtocols, and Master Batch Records.▪ Oversee the participation of the production team in the installation, qualification, and maintenance of the facilityproduction equipment. Executes approved protocols to validate manufacturing processes in coordination withproject managers. Maintain individual qualification requirements and training for entering ISO classified areas.▪ Demonstrate proficiency in industry radiation safety procedures. Responsible for tracking radiation exposure ofproduction personnel and seeing that principles of ALARA are maintained. Maintain a clean and safe workingenvironment and perform radiation safety duties in compliance with safety and pharmaceutical regulations.▪ Provide oversight to the materials utilized in the manufacturing process and ensure that raw materials,components, containers, closures, packaging, and labeling are inspected, qualified, and meet acceptance criteriabefore use.▪ Lead exception document initiation and investigation for manufacturing processes [Deviation, OOS, Action/AlertLevel 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 Controlprocedure is followed as required.▪ Monitor site production performance and manage departmental metrics by collecting key performance indicators.Collaborate cross functionally to discuss operations, issues/concerns, innovative ideas, and continuous qualityimprovements. Keep departmental costs within the budget and determine ways to reduce production costs usingLean tools.▪ Ability to work various shifts and weekends required. Perform routine production synthesis as needed.▪ Write reports, presentations, and other documentation summarizing data. Coordinate the RadiopharmaceuticalContract Manufacturing team's activities to reach defined objectives.▪ Liaise with our contract partners (e.g., biotech and pharma). Effectively communicate with customers, vendors,and other internal sites.▪ Perform other duties as assigned.
Qualifications:
▪ Bachelor’s degree in a scientific field is required with 10+ years of experience in radiopharmaceutical /pharmaceutical drug product manufacturing and production equipment management (qualification,troubleshooting and maintenance) required. Master’s degree with 7+ years of experience is preferred.▪ Three to five years of people management experience required.▪ Familiarity with radiation protection and safe handling of radioactive materials is required. Experience in radiationsafety is highly preferred.▪ Ability to read and interpret documents such as safety rules, operating and maintenance instructions, andprocedure manuals required.▪ Experience in cGMP manufacturing environment is highly preferred. Knowledge of cGMP requirements, asepticprocess (cleanroom environment), and equipment qualification is required.▪ Efficient in the use of MS Office Suite required.▪ Excellent organizational skills required. Knowledge of Lean Six Sigma preferred.▪ Cross functional communication skills in addition to collaboration and troubleshooting