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SOFIE
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  • Distribution Technician I  

    - Gilroy
    Looking for a role that keeps you moving and making an impact? The Dis... Read More
    Looking for a role that keeps you moving and making an impact? The Distribution Technician I helps produce, package, and distribute critical drug products while coordinating deliveries and maintaining accurate data records. If you're organized, dependable, and ready to be part of a team that supports patient care, this is the opportunity for you. Compensation: Shift: Essential Duties and Responsibilities Process shipping returns:Perform wipe test and survey containers according to Department of Transportation and Radiation Compliance Program standard operating procedures (SOPs) and company and agency regulations. Clean packing cases and unit dose containers previously containing drug product to work instructions. Prepare shipping containers for dose shipment: Perform wipe test and survey containers according to Department of Transportation and Radiation Compliance Program standard operating procedures (SOPs) and company and agency regulations. Clean and organize classified and non-classified areas within the facility: Assist with hazardous material waste removal and shipment. Assist staff with logistic routing to customer sites and track shipments and returns. Maintain and complete required paperwork, logs, documents, and reports. Complete cGMP documents as required within SOFIE's Quality Management System. Maintain a clean and safe working environment and perform radiation safety duties according to SOFIE's Corporate Radiation Compliance Program and site licensing requirements. Assist staff with communication between third-party courier services and customers. Other assigned duties as required. Qualifications High school diploma required. Experience in shipping, receiving, and/or logistics preferred. Efficient in the use of MS Office Suite required. Ability to work various shifts and weekends required. Ability to be detail-oriented, accountable, patient, organized, and work in a team environment required. Ability to communicate professionally with colleagues and customers, have excellent attention to detail, and be dependable and responsible in a fast-paced, highly technical environment required. Ability to lift 50 lbs. repetitively required. Read Less
  • Cyclotron-Support Engineer II/III  

    - Somerset
    Cyclotron-Support Engineer III Title Cyclotron-Support Engineer III Lo... Read More
    Cyclotron-Support Engineer III Title Cyclotron-Support Engineer III Location TBD Department Technical Services Reports To Field Service Engineer Overview The Cyclotron-Support Engineer III is accountable for the safe and routine operation, maintenance, and repair of one or more particle accelerators in SOFIE's PET radiopharmacy, which manufactures PET diagnostics under 21 CFR 212 guidelines. Additionally, the Cyclotron-Support Engineer III is responsibility for first-line troubleshooting, maintenance, and repair of equipment associated with manufacturing, including manipulator arms, lead shielded hot cells, radiosynthesizers, etc. The individual should be capable of independent decision-making abilities for most cyclotron and facility situations and will be called upon to trouble shoot non-routine manufacturing concerns. Essential Duties and Responsibilities Operate the cyclotron(s) according to proper operating procedures when manufacturing schedule requires (will include night shifts; may include weekend shifts). Perform routine, non-routine, scheduled, and emergency maintenance on the cyclotron(s). Complete documentation related to cyclotron operations per work instructions, including preventative maintenance, repair, and audit logs. Plan and execute accelerator maintenance activities on a schedule determined by the Tech Services management team. Perform diagnosis and repair on the following: Electronic equipment, electro-pneumatic systems, high vacuum systems, deionized chilled water systems, high voltage, target, and high-power RF systems. Provide timely information to supervisors regarding equipment operation and status. As a first-line support, maintain and repair all PET manufacturing equipment at the facility, including lead-shielded hot cells, manipulator arms, radiosynthesizers, etc. With the Facility Manager, oversee the work of all third-party contractors on equipment related to manufacturing. Perform radiation safety duties to SOFIE Radiation Compliance/Environmental Health and Safety Program standards to ensure compliance with all regulations under the Corporate and site RSO. Design and build equipment to improve operational reliability for cyclotron and isotope manufacturing. Ensure compliance with all procedures and regulations within the site under the Quality Assurance program as applicable, including participating in exception document reporting (e.g. deviations, corrective and preventative action plans, out-of-specifications, etc.) Provide technical training and support to other employees, Develop standardized operating procedures or work instructions for Cyclotron-Support Engineers on cyclotron, radiosynthesizer, hot cell, and manipulator arm use and maintenance. Perform trend analysis and tracking of cyclotron performance data. Provide after-hours on-call support to the site as needed. Oversee the activities of the Junior Cyclotron-Support Engineer (if assigned). Provide training for career path development to the Junior Cyclotron-Support Engineer (if assigned). Submit all work tickets, time cards, and expense reports in a timely manner. All other duties as required. Qualifications 10+ years of cyclotron experience or an Associate Degree in a Technical Discipline required. Working knowledge of digital and analog circuitry required. Able to troubleshoot electronics down to the component level preferred Ability to troubleshoot and repair cyclotron RF system. Ability to understand detailed theory of operation for most accelerator systems preferred. Ability to read and interpret mechanical and electrical drawings required. Knowledge of radiation survey meters required. Cross trained on all cyclotron models within the Sofie network. Experience in diagnosis and repair of equipment failures required. Experience with high voltage training preferred. Knowledge of basic cGMP practices and procedures preferred. Ability to define problems, collect data, establish facts, and draw valid conclusions required. Experience working with radioactive materials required. Ability to climb ladder and stairs, work in protective clothing, operate in confined spaces (i.e. inside or underneath the cyclotron) and lift a minimum of 50 lbs. required. Occupational exposure to ionizing radiation required. Excellent communication skills, ability to be detail-oriented, and dependability required. Experienced in Microsoft Suite required. Travel: up to 20%. Read Less
  • Scheduler, Supply Chain Manager  

    - Totowa
    Drive the flow of operations that bring life-changing pharmaceuticals... Read More
    Drive the flow of operations that bring life-changing pharmaceuticals from raw materials to clinical distribution. As the Scheduler, Supply Chain Manager, you will oversee end-to-end production processes, ensuring alignment with GMP standards and global regulatory expectations while optimizing sourcing, logistics, and distribution. Title Scheduler, Supply Chain Manager Location NJ5-Totowa, New Jersey Department Radiopharmaceutical Contract Manufacturing Training Curriculum ID TCU.005 Pay80,000-95,000/YR ( Based on experience and education) ShiftTBDOverview: The Scheduler, Supply Chain Manager is responsible for oversight of the production process from the procurement of raw materials through distribution logistics associated with the manufacture of safe, pure, effective, and sterile pharmaceuticals distributed for clinical and eventual commercial use in accordance with GMP guidance and FDA, EMA regulatory agencies) . The Scheduler, Supply Chain Manager optimizes essential areas of the supply chain (sourcing/procurement, production/operations, logistics and distribution) by employing performance analytics and forecasting tools to ensure customer satisfaction and operational efficiency. The Scheduler, Supply Chain Manager coordinates activities across a variety of our operation sections including administrative personnel, warehousing, manufacturing, quality control testing laboratories, quality assurance, project managers, and third-party distribution entities who together execute essential tasks to provide drug products to clinical sites on behalf of our clients. Essential Duties and Responsibilities The Scheduler, Supply Chain Manager supports the supply planning process for our CDMO in Totowa NJ providing critical, lifesaving therapeutic drugs to clinical sites. Assists in the development of supply strategies, helping to create and execute supply plans, identifying and reporting any risks or constraints that may affect product availability. Supply planning and execution. Includes analysis of unit operations and utilization of resource leveling strategies and operation management analytics to optimize process workflows. Participates in process improvement projects and initiatives to optimize supply chain processes. Leads process improvement and kaizen projects. Develop and execute supply plans for materials related to all product portfolios, creating an efficient mechanism to ensure on-time delivery of critical therapeutic drugs to clinical sites in North America and ROW. Maintain database of licensure and compliance related documentation of clinical sites supplied with theraputic dose and incoming radioisotope suppliers. Maintain accurate inventory levels, ensuring purchase orders are up to date for Drug Substance, Drug Product, finished goods, packaging consumables and incoming radioisotopes to meet demand. Customer and Stakeholder Engagement. Builds and maintains relationships with supply chain teams and stakeholders collaborating to ensure continuity of supply, through product delivery, and identifies potential risks. Receives and processes therapeutic drug orders from customers and clinical sites Coordinates with client/customer based clinical supply teams, external suppliers, site manufacturing/operations and distribution logistics to ensure manufacturing and delivery of our drug products on time. Monitor changes in demand, communicate with stakeholders to adjust production plans, and incorporate changes into site production schedules. Risk Management and Problem Solving Identifies and resolves supply constraints, working closely with stakeholders. Provides input into budget processes, inventory projections, and root cause analysis for any supply issues. Supports new product introductions while maintaining clinical supply demand for existing products. Follows SOPs, fulfills orders, and maintains a high level of accuracy across data platforms utilized in clinical distribution reporting, quality metrics, and KPI / performance analytics. Digital acumen, analytics, and learning. Demonstrates interest and adaptability in learning digital tools and platforms (Power BI, Salesforce, forecasting systems) and integrates them into daily operations. 100% site essential role at our Totowa NJ manufacturing facility. Performs other tasks/duties as assigned. Qualifications Minimum B.S. Degree in supply chain management, business administration, industrial engineering, and/or other applicable engineering curriculum 2+ years of experience in supply chain management in a pharmaceutical environment required. Course work in operations management and planning analytics preferred. Experience with radioisotope supply and just-in-time radiopharmaceutical logistics preferred. Understanding of radiopharmaceutical global import/export requirements preferred. Experience in a pharmaceutical manufacturing environment with clinical or commercial distribution preferred. Knowledge of supply chain operations. Proficient with ERP systems, planning/operational software, physical and transactional workflows. Excellent interpersonal, communication, and negotiation skills. Base understanding of regulatory requirements, particularly in the pharmaceutical industry (cGMP, FDA, EMA) Strong problem solving, analytical and organizational skills. Ability to manage multiple tasks and priorities effectively and under tight deadlines. Ability to work overtime as needed. Able to perform tasks with minimal error rate. Ability to lift 50 pounds. Read Less
  • Support a critical transition in SOFIE's quality systems. The Temporar... Read More
    Support a critical transition in SOFIE's quality systems. The Temporary Quality Assurance Specialist (QAS), Document Administration plays a key role in organizing, editing, and migrating documents to support the successful deployment of the TrackWise Document Management System and QMS modules across the organization. Job Description Temporary Quality Assurance Specialist (QAS), Document Administration Title Temporary Quality Assurance Specialist (QAS), Document Administration (6 Month role) Department Quality & Compliance Reports To Director, Quality Management or Project Manager (Training based on assigned duties) Shift: 9am-5pm Pay: $36/HR Overview The Temporary Quality Assurance Specialist (QAS), Document Administration will be responsible for organization and editing of documents to facilitate migration and deployment of the TrackWise Document Management System (DMS) and TrackWise change and exception management modules (QMS). This additionally includes organization and migration, as needed, of legacy documents not migrated to DMS or QMS. This position is located at SOFIE's Center of Excellence in Totowa, NJ but will support document administration needs locally and for the wider SOFIE network. Essential Duties and Responsibilities • Under supervision of site QA or corporate document control, prepare migration spreadsheets and perform other word processing and document organization tasks for migration of documents from existing libraries (in SharePoint) to TrackWise. • Edit documents to be migrated to ensure clean appearance once migrated, and that documents remain clear and readable. • Edit references and cross references in documents when migrated to ensure those references remain clear and correct. • Assist in managing document attachments during migration; this may include separating imbedded documents from the body of SOPs, editing attachments, and file and folder organization. • Under supervision of site QA or corporate document control, organize legacy documents not migrated to TrackWise to ensure that documents remain searchable and readily retrievable. • To support document control functions generally, as assigned, review documents for completeness, errors, and omissions. • Perform other word processing duties as assigned. • Attend quality and operational meetings as necessary. Interface with Corporate QA on document control related issues. Provide work progress updates. • Other responsibilities as required. Qualifications • AS Degree in a related field with 2+ years of experience in Quality Assurance or Document Control function (or equivalent combination of education and experience). • Understanding of TrackWise products preferred. • Knowledge of cGMP regulations preferred. • Technical writing skills preferred. • Ability to effectively present information and respond to questions from groups of managers and staff. • Proficiency in MS Office application required. • Strong interpersonal communication skills. Read Less
  • Laboratory Technician  

    - Totowa
    Looking to build your lab experience in a fast-paced, impact-driven en... Read More
    Looking to build your lab experience in a fast-paced, impact-driven environment? As a Laboratory Technician, you'll support QC and Microbiology teams by ensuring reagents, supplies, and equipment are ready for use while also performing essential Environmental Monitoring that protects our facility and products. Title Laboratory Technician Location NJ5-Totowa, New Jersey Department Radiopharmaceutical Contract Manufacturing Training Curriculum ID TCU.004 Pay: $24-$28/HR Shift: 2:00am to 10:30am Overview: The Laboratory Technician supports the QC and Microbiology departments at the NJ5 site by (1) preparing and maintaining reagents and other supplies in the QC Laboratory, disposing of used supplies, and performing simple instrument calibration and maintenance, and (2) performing Environmental Monitoring (EM) and by preparing/maintaining EM supplies and disposing of used EM supplies. Essential Duties and Responsibilities Prepare standards, samples, and mobile phase solutions for analytical methods. Perform simple calibration and maintenance of QC and microbiology laboratory equipment on site. Dispose of QC and microbiology waste (common, biologic, hazardous, and radioactive) in accordance with instructions and regulatory requirements. Perform routine housekeeping and cleaning in the QC and microbiology laboratories. Operate lab glassware washer and manage glassware within the labs. Assist with EM sampling in accordance with schedules, and procedures, performing sampling of rooms and equipment. Assist with sampling, handling, and shipping of QC and microbiology samples for external testing, including raw material, finished product and environmental isolate samples. Assist with non-complex Quality Control analytical tests, under supervision of chemists, for regular production of radiopharmaceuticals for preclinical, clinical, or commercial use according to cGMP standards. Comply to all applicable standard operating procedures and regulations, including 21 CFR Part 211 and Eudralex Volume 4 requirements. Maintain all qualification and validation requirements for entering ISO classified areas. Maintain a clean and safe working environment and perform radiation safety duties in compliance with safety and pharmaceutical regulations. Other duties as assigned. Qualifications Minimum Associate Degree in a Life Science discipline (in chemistry, biology/ microbiology, or related field preferred) and 0-3 years in a cGMP laboratory/ production environment including supporting QC and/or microbiology services. Knowledge of and previous experience performing Environmental Monitoring is preferred. Knowledge of USP, FDA, and cGMP regulations preferred. Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals required. Ability to define and solve problems, collect data, establish facts, and draw valid conclusions required. Proficiency in MS Office applications required. Strong interpersonal communication skills for interacting with site personnel in both quality and manufacturing. Read Less
  • Warehouse Material Handler  

    - Totowa
    Join a team dedicated to producing safe, pure, and effective pharmaceu... Read More
    Join a team dedicated to producing safe, pure, and effective pharmaceuticals. The Warehouse Material Handler helps keep our NJ5 facility running smoothly by managing critical materials, supporting multiple departments, and maintaining strict compliance with SOPs and GMP requirements. Title Warehouse Material Handler Location NJ5-Totowa, New Jersey Department Radiopharmaceutical Contract Manufacturing Training Curriculum ID TCU.008 Pay$29-$34/HR ShiftTBDOverview: The Warehouse Material Handler is responsible for the movement of materials, including finished products, associated with the manufacture of safe, pure, effective, and sterile pharmaceuticals, in accordance with company SOPs, policies, and procedures and in accordance with GMP guidance. The Warehouse Material Handler provides support to the NJ5 facility and other departments as needed to maintain production schedules and meet company goals and is responsible for moving, storing, and tracking materials in a highly regulated pharmaceutical manufacturing environment. The Warehouse Material Handler provides support to the Warehouse Supervisor in receiving, sampling, disposition, labeling, dispensing, storage, shipping, destruction, and accurate completion of associated documentation as per applicable Standard Operating Procedures. Essential Duties and Responsibilities Control incoming raw materials, and move materials through process areas under QA oversight, including: Receiving, inspecting, and unpacking material delivered by common carriers. Staging/storing materials in accordance with their disposition and utilization. Transferring materials to the manufacturing line according to Standard Operating Procedures. Support the Warehouse Supervisor in: Performing inspection of materials Sampling materials for testing and retention. Accurately completing vendor submission forms and ship samples for testing Maintaining Material History Folders and Use Logs. Reconciling material use. Maintain controlled receiving, quarantine, and accepted material storage rooms, assuring the areas are organized, orderly, and clean and that materials are correctly segregated. Maintain rejected material storage areas and facilitating destruction by external vendors. Maintain retain sample storage areas. Maintain supplies required to sample, store, segregate, and ship raw materials. Support the Metrology sections in moving process materials when validating controlled temperature storage chambers, sampling booths, etc. Support Environmental Health and Safety sections in segregating waste material and transferring to vendors for waste removal. Assist in packaging and shipping of finished products as needed. Maintain material storage areas and documentation in preparation for regulatory inspections and client audits. Provide support to the Warehouse Supervisor and Inventory Control Specialist for regulatory inspections and client audits. Ensure all work is performed and documented in accordance with cGMP requirements and existing company policies and procedures. Perform other tasks/duties as assigned. Qualifications Minimum AS Degree in a related field with 1+ years of experience in a Warehousing or Material Handling function in an FDA-regulated environment required (or equivalent combination of education and experience). Experience in a pharmaceutical manufacturing environment preferred. Ability to do work independently, recognizing what needs to be done and accomplishing it with minimal supervision required. Intermediate skills in Microsoft Word and Excel required, experience with inventory management software a plus. Excellent organizational, interpersonal, and communication skills (written and oral) required. Ability to take feedback constructively and function in a team-oriented work environment required. Ability to work overtime as needed required. Able to perform tasks with minimal error rate required. Ability to lift up to 50 pounds; experience with pallet jacks and/or fork trucks a plus. Read Less
  • Environmental Monitoring Technician  

    - Totowa
    As a Microbiology - Environmental Monitoring Technician, you'll help e... Read More
    As a Microbiology - Environmental Monitoring Technician, you'll help ensure product quality and safety while contributing to a life-changing industry. Title Environmental Monitoring Technician Location Totowa, New Jersey Department Radiopharmaceutical Contract Manufacturing Compensation $24-$28/HR ( Based on experience and education) Overview: The Microbiology - Environmental Monitoring Technician supports microbiology and manufacturing activities at the NJ5 site by (1) performing Environmental Monitoring (EM) as per sampling schedules (2) detecting, quantifying, identifying, and aiding in investigations for possible contaminants that may impact the quality of product during different stages of the manufacturing process. Essential Duties and Responsibilities Provide Environmental Monitoring (EM) support to GMP manufacturing areas. Perform EM testing for Active and Passive (settle plate) monitoring of Viable Particulates (Viable Air and Viable Surface - RODAC), and Non-Viable Total Particulates. Follow EM sampling schedules in accordance with procedures, performing sampling of rooms and equipment. Perform EM sample management from incubation through isolate ID and completion of EM documentation. Work independently and with cross-functional groups to implement the environmental monitoring program to ensure the compliance of facility. Aid in EM investigations to determine root cause and provide expert guidance on required corrective actions for EM excursions. Assist in Growth Promotion conduction as necessary for EM related media. Support Microbiology team in the conduction of trending EM and relevant Out of Specification (OOS) data against acceptance specifications. Notify Microbiology/ EM Supervisor, Quality Control Manager, and Facility Manager of any identification of all microbial contamination. Support finished product release by checking results for sterility, endotoxin, and particulate matter testing (as required). Maintain aseptic environment for Microbiology and Stability laboratories, including regular maintenance of all equipment pertaining to EM. Disposal of hazardous waste and non-hazardous waste from Microbiology / Stability laboratories. Interact with management to suggest approaches to increase efficiency that will allow for better operations in the laboratory. Follow compliance to all applicable standard operating procedures and regulations, including 21 CFR Part 211 and 212 requirements. Other responsibilities required. Qualifications Bachelor's Degree in a Life Science discipline (B.Sc. in biology/ microbiology or related field preferred) and 0-3 years in a cGMP laboratory/ production environment including performing environmental monitoring. Knowledge of and previous experience performing Environmental Monitoring is preferred. Knowledge of USP, FDA, and cGMP regulations preferred. Knowledge of how and ability to write, review, and revise SOPs required. Ability to read, analyze, and interpret governmental regulations, professional journals, or technical procedures required. Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals required. Ability to define and solve problems, collect data, establish facts, and draw valid conclusions required. Proficiency in MS Office applications required. Strong interpersonal communication skills for interacting with site personnel in both quality and manufacturing. Read Less

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Astrid-Lindgren-Weg 12 38229 Salzgitter Germany