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Understand and apply knowledge of isolator technology to ensure appropriate validation and operational support. Understand sterility assurance concepts and contamination control strategy requirements, and assist in implementing associated regulations. Design and support media fill activities to simulate aseptic production conditions and verify the sterility of the filling process. Draft, review, and approve SOPs and other technical documents related to sterile filling operations. Collaborate with cross-functional teams to support technology transfer, process validation, and troubleshooting activities. Ensure compliance with all relevant GMP and safety standards. Bachelor's or Master's degree in Chemical Engineering, Biochemical Engineering, Biotechnology, or related field. A minimum of 3-5 years of experience in the biotech or pharmaceutical industry, with a focus on sterile filling operations. Experience with PFS and vial filling operations. Strong understanding of isolator technology. Experience with designing and supporting media fill activities. Strong understanding of GMP regulations and guidelines. Excellent problem-solving skills and the ability to work effectively in a team environment. Strong written and verbal communication skills.", "stars": 0.0, "medallionProgram": null, "location_flexibility": null, "work_location_option": null, "canonicalPositionUrl": "https://modernatx.eightfold.ai/careers/job/309256294448", "isPrivate": false}, {"id": 309256294462, "name": "Senior Research Associate, Manufacturing Science and Technology (MS&T) - Formulation", "location": "Melbourne - Australia", "locations": ["Melbourne - Australia"], "hot": 0, "department": "Manufacturing and Operations", "business_unit": "Jerh Collins", "t_update": 1701575291, "t_create": 1696982400, "ats_job_id": "R14510", "display_job_id": "R14510", "type": "ATS", "id_locale": "R14510-en", "job_description": "Provide technical expertise and support on quality issues related to the formulation, filling of sterile drugs, and the use of single-use mixers and materials. Serve as a subject matter expert (SME) and SOP writer for formulation processes. Lead investigations, manage deviations, and implement corrective and preventive actions (CAPA) as needed. Conduct troubleshooting and process monitoring to ensure optimal performance of formulation processes. Draft, review, and approve GMP documents related to formulation processes. Support internal and external audits as a technical expert in formulation. Facilitate and manage interfaces between Operations and Quality Organization. Bachelor's or Master's degree in Chemical Engineering, Biochemical Engineering, Biotechnology, or related field. A minimum of 3-5 years of experience in the biotech or pharmaceutical industry, with a focus on drug formulation and filling processes. Experience with single-use technologies in a pharmaceutical manufacturing environment. Strong understanding of GMP regulations and guidelines. Proven ability to troubleshoot issues related to single-use technologies. Strong written and verbal communication skills.", "stars": 0.0, "medallionProgram": null, "location_flexibility": null, "work_location_option": null, "canonicalPositionUrl": "https://modernatx.eightfold.ai/careers/job/309256294462", "isPrivate": false}, {"id": 309256619065, "name": "Senior Research Associate, Manufacturing Science and Technology (MS&T) - Validation", "location": "Melbourne - Australia", "locations": ["Melbourne - Australia"], "hot": 0, "department": "Manufacturing and Operations", "business_unit": "Jerh Collins", "t_update": 1701574720, "t_create": 1699315200, "ats_job_id": "R14651", "display_job_id": "R14651", "type": "ATS", "id_locale": "R14651-en", "job_description": "Conduct process risk assessments and develop strategies to mitigate risks and improve process robustness. Validation Method Consistency: Ensure consistent application of the validation method across the new drug product manufacturing lines. Document Creation and Support: Oversee the creation of procedure-type documents and training support. Analyze process data, perform statistical analysis, and generate reports to support process characterization and validation activities. Qualification and Validation Support: Assist in commissioning, qualification, and validation activities for the drug product premises. Knowledge Management: Develop and implement knowledge management programs. Technical Support: Provide expertise to manufacturing operations, troubleshoot process-related issues, and identify root causes. Quality Assurance: Collaborate with the QA team to ensure compliance with cGMP and regulatory requirements. Technology Transfer Support: Support activities from development to commercial manufacturing, ensuring successful process transfer and implementation. Training: Train manufacturing personnel on new processes, equipment, and technologies. Bachelor's or Master's degree in a scientific or engineering discipline (Chemical Engineering, Pharmaceutical Sciences, or related field). Experience in a pharmaceutical manufacturing environment, preferably in a role related to aseptic fill finish process, process optimization, or technical support. Experience with creating and delivering training programs. Familiarity with process validation principles and statistical analysis techniques. Proficient in data analysis software and statistical tools. Excellent problem-solving and troubleshooting skills. Strong communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams.", "stars": 0.0, "medallionProgram": null, "location_flexibility": null, "work_location_option": null, "canonicalPositionUrl": "https://modernatx.eightfold.ai/careers/job/309256619065", "isPrivate": false}, {"id": 309256698220, "name": "QA Operations Head", "location": "Melbourne - Australia", "locations": ["Melbourne - Australia"], "hot": 0, "department": "Quality", "business_unit": "Jerh Collins", "t_update": 1701574337, "t_create": 1699833600, "ats_job_id": "R14676", "display_job_id": "R14676", "type": "ATS", "id_locale": "R14676-en", "job_description": "Manage a team of QA professional responsible for: On-the-Floor manufacturing oversight, Deviation Management, Change Management, Batch Record Review and Product Disposition. Demonstrate dynamic range with the capability to also directly support these expectations. Enforce adherence to current good manufacturing practices, standard operating procedures, and manufacturing documentation. Monitor key quality system metrics and process indicators to ensure adherence to compliance and performance expectations. Engage in plant tiered governance that supports performance expectations that includes quality, delivery, and safety. Collaborate closely with cross-functional partners and as an active member of leadership. Support the training and development of the QA team including coordination of training, capability assessment and enhancement, and professional development. Author, review and/or approve documentation, including SOPs, to ensure compliance and adherence to regulations/cGMP operations. Be a champion for continuous improvement in all aspects of total quality management through a well-trained workforce, streamlined business processes, and appropriate structured quality operations. Utilize knowledge to improve operational efficiency. Ensure inspection readiness and provide guidance and support relative to Good Manufacturing Practices (GMPs). Bachelor's Degree in a science field (e.g., Biology, Microbiology, Chemistry, Pharmacy, etc.) or equivalent combination of education and experience 8 - 10+ years of pharmaceutical or related work experience with emphasis on current Good Manufacturing Practices Demonstrated ability making risk based decisions Sterile drug product manufacturing experience preferred", "stars": 0.0, "medallionProgram": null, "location_flexibility": null, "work_location_option": null, "canonicalPositionUrl": "https://modernatx.eightfold.ai/careers/job/309256698220", "isPrivate": false}, {"id": 309256454409, "name": "Production Team Lead", "location": "Melbourne - Australia", "locations": ["Melbourne - Australia"], "hot": 0, "department": "Manufacturing and Operations", "business_unit": "Jerh Collins", "t_update": 1701575180, "t_create": 1698192000, "ats_job_id": "R14602", "display_job_id": "R14602", "type": "ATS", "id_locale": "R14602-en", "job_description": "Health and Safety: Accountable of enforcing local laws HSE requirements. Adhere to and reinforce gowning procedures and maintain a clean general operating area. Opens and investigates incidents and HSE events in coordination with other functions. Develop batch records, SOPs and training materials as needed for various phases of commercial programs at the Facility. Closely partner with QA peers for closure of documentation required for timely disposition of commercial batches. Works autonomously within current good manufacturing practices, standard operating procedures, and manufacturing documentation. Establish and follow written procedures for the clear and accurate documentation of equipment operation and process instructions, and of process data. Opens and investigates deviations in coordination with other functions. Ensure plans and resources (people, facilities, supplies etc.) are efficiently utilized to manufacture mRNA medicines and deliver on time to the commercial market. Ensure performance monitoring of the team according to KPI in place and take actions to correct course if need be. Collaborate with Supply Chain, maintain inventory and review process orders. Oversee the training, development, retention, and performance of staff for the execution of manufacturing operations. Manage team's performance (recognition and rewards, succession planning as well as nonperformance) through regular periodical one on one's Develop comprehensive operating plans to ensure success of direct team and communication to other commercial platform teams. Recognized as a mentor and trainer to others and strives to make the team better. Effectively escalate information to Commercial Manufacturing management as required. Typically, 5-10+ years of experience in a GMP manufacturing environment. A Bachelor's Degree in Biology, Chemistry, Chemical engineering, Biomechanical engineering, Bioengineering, Biomedical engineering, Biochemistry or related field preferred. Proven track record of success in a fast-paced production environment at a biotech/pharmaceutical company preferably in GMP. Ability to collaborate fluidly with peers, supervisors and cross-functional support groups required. Exceptional written, oral communication, and organizational skills required. Experience with chromatography and tangential flow filtration would be an asset. Experience in audit / inspection preparation, understanding Health authority and regulatory guidelines.", "stars": 0.0, "medallionProgram": null, "location_flexibility": null, "work_location_option": null, "canonicalPositionUrl": "https://modernatx.eightfold.ai/careers/job/309256454409", "isPrivate": false}, {"id": 309256294403, "name": "Production Head DS (Lead Team)", "location": "Melbourne - Australia", "locations": ["Melbourne - Australia"], "hot": 0, "department": "Manufacturing and Operations", "business_unit": "Jerh Collins", "t_update": 1701574362, "t_create": 1696982400, "ats_job_id": "R14508", "display_job_id": "R14508", "type": "ATS", "id_locale": "R14508-en", "job_description": "The role is pivotal to the ongoing operations and growth of our Australia site, involving equipment procurement and qualification, SOP development/deployment, electronic batch record implementation, and training material improvements. The successful candidate will play a key role in preparing the site for GMP inspection and certification, including equipment installation support, QMS implementation, staff recruitment, training, and development. In addition, you will: Lead a team of Supervisors/Team Leads and Technical Specialists, including third party service providers to safely produce RNA-based medicines to support commercial manufacturing of vaccines (Covid, Flu, RSV). Optimize plans and resources (people, facilities, supplies etc.) for efficient manufacturing and timely delivery. Actively participate in recruitment, training, development, retention, and performance management of staff for effective manufacturing operations. Provide on-the-floor coaching of the manufacturing and support teams on process execution within a GMP environment. Ensure the development and maintenance of batch records, SOPs, and training materials for the DNA processes. Maintain the work center in a constant state of inspection readiness. Support onsite inspection activity as required. Collaborate closely with QA peers for rapid batch disposition, including ensuring timely batch record, protocol, and log reviews, deviation investigation support, etc. Be an efficient matrix contributor and collaborate effectively in a cross functional local and global settings with MST, Ops, SC, etc. Drive operational readiness for new product introductions and technology transfers. Develop comprehensive operating plans in collaboration with cross-functional peers and monitor the achievement of business and financial goals. Manage multiple projects alongside operations in a fast-paced environment. Foster a culture of continuous improvement leveraging Lean and Six Sigma principles. We are looking for someone with a strong background in Operational Excellence to establish a robust foundation of Tier systems, Lean, and Six Sigma principles throughout the facility startup and ramp up phase. In addition: A university degree in engineering or sciences and 12 or more years of experience in all manufacturing processes in a pharmaceutical or biotechnology environment. Proven senior plant management experience and a strong background in implementing Tier (Lean) principles. Strong quality mindset, with deep understanding of cGMP guidelines and regulations. Excellent communication and presentation skills. Proficiency in English required. Proficiency in conflict resolution and crucial conversations. Technical writing skills and proficiency in investigations and root cause analysis. Proven ability to assess risk, collaborate with support groups to develop suitable action plans, and minimize potential impact. A desire to be part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.", "stars": 0.0, "medallionProgram": null, "location_flexibility": null, "work_location_option": null, "canonicalPositionUrl": "https://modernatx.eightfold.ai/careers/job/309256294403", "isPrivate": false}, {"id": 309256251427, "name": "Drug Substance MS&T Lead", "location": "Melbourne - Australia", "locations": ["Melbourne - Australia"], "hot": 0, "department": "Manufacturing and Operations", "business_unit": "Jerh Collins", "t_update": 1701574876, "t_create": 1696550400, "ats_job_id": "R14466", "display_job_id": "R14466", "type": "ATS", "id_locale": "R14466-en", "job_description": "Manage and document process and project information with a robust documentation package. Be the point of contact for manufacturing issues requiring technical investigations. Identify root cause. Coordinate and resolve issues with effective CAPAs. Manage change as part of a Global Change Control forum. Maintain alignment with other global manufacturing sites through shared knowledge, shared manufacturing data, shared manufacturing issues, and common solutions. Lead a diverse group of scientists and engineers by establishing common practices, establishing a data-driven culture, using metrics for improvements, and being hands-on in risk assessment and defining solutions. Actively participate in health authorities' audits. M.S. or Ph.D. in a technical discipline related to Pharmaceutical Manufacturing (Chemistry, Biochemistry, Chemical Engineering, Pharmaceutical Engineering, etc.) A minimum of 10 years of related work experience. Prior managerial experience. Ability to mentor staff in technical areas outside your area of expertise. Direct experience providing technical support of cGMP manufacturing operations in biologics manufacturing or parenteral drug product manufacturing. Experience includes technology transfer, investigations, and change management. Experience using statistical process control and process analytics for monitoring and improving control of processes. Demonstrated capability of working cross-functionally in a technical area outside of core expertise. Experience supporting commercial cGMP manufacturing processes preferred.", "stars": 0.0, "medallionProgram": null, "location_flexibility": null, "work_location_option": null, "canonicalPositionUrl": "https://modernatx.eightfold.ai/careers/job/309256251427", "isPrivate": false}, {"id": 309257045613, "name": "MST DS Engineer III", "location": "Melbourne - Australia", "locations": ["Melbourne - Australia"], "hot": 0, "department": "Manufacturing and Operations", "business_unit": "Unknown", "t_update": 1701574455, "t_create": 1701302400, "ats_job_id": "R14791", "display_job_id": "R14791", "type": "ATS", "id_locale": "R14791-en", "job_description": "Act as a technical expert in cGMP manufacturing at Australia site including authoring of technology transfer documents, supporting change controls, closing manufacturing investigations, and helping validation actives. Analyze manufacturing performance through data review and analyses. Author manufacturing summary reports. Establish and maintain data repositories. Lead cross functional troubleshooting and operational improvements for manufacturing process and equipment. Author and execute protocols supporting process characterization and equipment scale up in cGMP Manufacturing. Maintain alignment with other global manufacturing sites through shared knowledge, shared manufacturing data, shared manufacturing issues, and common solutions. Biochemical engineer, Chemical engineer, or Biochemistry background. BS with more than 6 years of experience or MS with more than 3 years experience in a pharmaceutical or biotechnology company Process development or operational experience in one or more of the following bioprocessing unit operations: Enzymatic reaction, chromatography, tangential flow filtration, buffer formulation, drug product formulation, and aseptic filling. Experience in providing technical support to cGMP manufacturing organization Experience in working with single use consumables, SS tanks and skids Experience in supporting tech transfer, change control, investigation, and data analysis. Outstanding communication skills (verbal and written) Ability to manage projects in a fast-paced environment. Ability to effectively collaborate in a dynamic, cross-functional matrix environment. Ability to adapt to new and challenging technical opportunities.", "stars": 0.0, "medallionProgram": null, "location_flexibility": null, "work_location_option": null, "canonicalPositionUrl": "https://modernatx.eightfold.ai/careers/job/309257045613", "isPrivate": false}, {"id": 309257064879, "name": "Director, Drug Product Production Lead", "location": "Melbourne - Australia", "locations": ["Melbourne - Australia"], "hot": 0, "department": "Manufacturing and Operations", "business_unit": "Jerh Collins", "t_update": 1701576345, "t_create": 1701388800, "ats_job_id": "R14798", "display_job_id": "R14798", "type": "ATS", "id_locale": "R14798-en", "job_description": "The role is pivotal to the ongoing operations and growth of our Australia site, involving batch readiness and close out in partnership with the Manufacturing Leadership Team and drive cross-functional projects to completion. This person is a key contributor to technology transfer and all activities directly support manufacturing readiness. The Drug Product Production leader can effectively represent their functional area on site initiatives and capable interfacing with cross functional teams. In addition, you will: Lead a team of Supervisors/Team Leads and Technical Specialists, including third party service providers to safely produce RNA-based medicines to support commercial manufacturing of vaccines (Covid, Flu, RSV). Optimize plans and resources (people, facilities, supplies etc.) for efficient manufacturing and timely delivery of high quality product. Actively participate in recruitment, training, development, retention, and performance management of staff for effective manufacturing operations. Provide on-the-floor coaching of the manufacturing and support teams on process execution within a GMP environment. Ensure the development and maintenance of batch records, SOPs, and training materials for the manufacturing processes. Maintain the work center in a constant state of inspection readiness. Support onsite inspection activity as required. Collaborate closely with QA peers for rapid batch disposition, including ensuring timely batch record, protocol, and log reviews, deviation investigation support, etc. Be an efficient matrix contributor and collaborate effectively in a cross functional local and global settings with MST, Ops, SC, etc. Drive operational readiness for new product introductions and technology transfers. Develop comprehensive operating plans in collaboration with cross-functional peers and monitor the achievement of quality, business and financial goals. Manage multiple projects alongside operations in a fast-paced environment. Ensure manufactured products are produced and stored according to the appropriate documentation in order to obtain the required quality. Approve instructions relating to production operations and ensure their strict implementation by the site. In collaboration with Quality and MS&T, coordinate investigations and troubleshooting efforts at site. Review and approve the appropriate GMP documentations as required e.g: change request, deviations, master batch records, annual product quality reviews (APR/PQR), internal SOP\u00b4s. Drive for and implement agreed continuous improvements. Lead and track life cycle projects impacting manufacturing operations, in close collaboration Regulatory, MS&T, Supply Chain and Quality operations. Collaborate with internal cross-functional teams to understand needs/expectations for site performance. Drive capability and capacity to enable on-time and predictable delivery of the product. Lead periodic reviews and execution of the MPS (Master Production Schedule) Ensure seamless integration across all functions of the value chain with Operations, Supply Chain, Quality Control, Quality Assurance, MS&T, and Facilities & Engineering, digital, along with partnership with SG&A groups to meet business objectives assigned to the plant. Foster a strong culture which is inclusive, collaborative, engaged, compliant, safety minded and highly personally accountable. Coach team for positive inter-departmental collaboration. A university degree in engineering or sciences and 12 or more years of experience in all manufacturing processes in a pharmaceutical or biotechnology environment. 12 years' experience in Pharmaceutical/Biotechnology Industry Experience in mRNA vaccine manufacturing process or operational experience in drug product formulation, lipid nanoparticles formulation and aseptic filling are advantageous. Proven senior plant management experience and a strong background in implementing Tier (Lean) principles. Strong quality mindset, with deep understanding of cGMP guidelines and regulations. Excellent communication and presentation skills. Proficiency in English required. Proficiency in conflict resolution and crucial conversations. Technical writing skills and proficiency in investigations and root cause analysis. Proven ability to assess risk, collaborate with support groups to develop suitable action plans, and minimize potential impact. A desire to be part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.", "stars": 0.0, "medallionProgram": null, "location_flexibility": null, "work_location_option": null, "canonicalPositionUrl": "https://modernatx.eightfold.ai/careers/job/309257064879", "isPrivate": false}, {"id": 309256223398, "name": "MS&T Drug Product Site Lead", "location": "Melbourne - Australia", "locations": ["Melbourne - Australia"], "hot": 0, "department": "Manufacturing and Operations", "business_unit": "Jerh Collins", "t_update": 1701574589, "t_create": 1696377600, "ats_job_id": "R14429", "display_job_id": "R14429", "type": "ATS", "id_locale": "R14429-en", "job_description": "The role is pivotal to the ongoing operations and growth of our Melbourne, Australia site, involving equipment procurement and qualification, SOP development/deployment, electronic batch record implementation, and training material improvements. The successful candidate will play a key role in preparing the site for GMP inspection and certification, including equipment installation support, QMS implementation, staff recruitment, training, and development. In addition, you will: Provide technical leadership to the MS&T team in Australia, supporting the DP activities and collaborating closely with other site functions. Drive operational readiness for new product introductions and technology transfers. Develop comprehensive operating plans in collaboration with cross-functional peers. Support process training for the local MS&T team. Lead a team of Supervisors/Team Leads and Technical Specialists to transfer in produce RNA-based medicines to support commercial manufacturing of vaccines. Actively participate in recruitment, training, development, retention, and performance management of staff for effective manufacturing operations. Support onsite inspection activity as required. Lead troubleshooting and investigational activities to resolve deviations or improve DP operations. Be an efficient matrix contributor and collaborate effectively in a cross functional local and global settings with MST, Ops, SC, etc. Manage multiple projects alongside operations in a fast-paced environment. Foster a culture of continuous improvement leveraging Lean and Six Sigma principles. Utilize your expertise in DP processes, with a preference for mRNA, to analyze process information and identify opportunities for improvement, yield optimization, and enhanced process capabilities. Define and assist in Change Control management strategy in alignment with regulatory requirements. We are looking for someone with a strong background in Operational Excellence to establish a robust foundation of Tier systems, Lean, and Six Sigma principles throughout the facility startup and ramp up phase. In addition: A university degree in engineering or sciences and 10+ years of experience in the pharmaceutical or biotechnology industry, with a focus on DP processes. Be a subject matter expert in at least 2 of the following areas: Compounding & Filtration, Automated Visual Inspection, Packaging, Frozen CCI, PFS, FMEA/risk assessments, process monitoring & data analytics. Proven senior experience in tech transfers and project leadership. Extensive knowledge of quality systems, cGMP, and industry standards at all phases of drug development. Excellent communication and presentation skills. Proficiency in English required. Proficiency in conflict resolution and crucial conversations. Technical writing skills and proficiency in investigations and root cause analysis. Proven ability to assess risk, collaborate with support groups to develop suitable action plans, and minimize potential impact. 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