BioNJ, the membership trade association for life sciences in New Jersey, is proud to announce an entry level position which will allow the successful candidate to join a dynamic, high energy, highly productive Team to develop their communication and relationship building skills. The successful candidate will work to ensure Member satisfaction through positive interactions and excellence in communications and related activities. Some responsibilities will include supporting VP, Member Engagement & Strategic Partnerships; assisting with Member communications and activities, including on-boarding; fielding questions and information requests from Members; and working alongside the Operations Department. Additionally s/he will maintain and update Membership database, process Membership applications and renewals, collect data tracking Membership statistics and analyze data and prepare reports. More...

Magic Hat Consulting is investing in a select few Strategic Account Lead roles. These new roles are being created to elevate our partnerships with premier clients. The Account Lead role provides the right candidates an outstanding opportunity to work with Top 10 Global Pharmaceutical Companies. The ideal candidates will be well-respected life sciences leaders who have developed deep and trusted professional networks; are viewed as trusted partners who develop solutions and deliver results, both working and delivering independently or leading others; can effectively identify business opportunities and lead sales pursuits and secure new engagements while “rolling up your sleeves” and playing a key role in delivery; and be consummate team players who consistently deliver outstanding client experiences, always willing to go above and beyond to ensure client satisfaction is achieved. More...

The qualified candidate will be responsible for supporting the production activities for Manufacturing and Packaging, as well as identify, evaluate, implement and support IT/automation solutions and information systems to meet FUS business objectives. The role will provide technical expertise with a focus on Compliance and Performance. Some responsibilities will include serving as a representative for production information and automation systems with a focus on customer support; assisting in trouble-shooting challenging IT/automation issues to improve manufacturing for assigned systems; maintaining the IT/automation systems in compliance with cGMPs; providing support as a representative of a start-up or existing production team providing technical assistance in fulfilling the IT/automation requirements for the team; and developing and supporting corrective actions for investigations related to automation or IT systems. More...

Incumbent will ensure the efficient and safe operation of all physical infrastructure, systems and equipment within the facility. S/he will interact with QC, QA, Tech services, IT, Procurement, Materials Management, Laboratories, other departments, external vendors and government agencies as required. Some responsibilities will include facilitating mechanical and electromechanical piping system, such as water supply, compressed air, plant steam, waste treatment, Life Safety systems and Clean Utilities operations; overseeing the activities of hourly maintenance employees providing technical training, development and support feedback on annual performance reviews; providing support on equipment and systems including BMS/EMS, HVAC and electrical infrastructure; and interacting with other facility and maintenance team members and as the SME/S (Subject Matter Expert/Specialist) provides support in their effort to effect maintenance work and plan any other short term or long-term project. More...

Candidate will help accelerate the digital transformation of the organization. The position is very visible and will be responsible for overseeing technology solutions, technology architecture and technology delivery standards for multiple concurrent products as well as providing technical and execution excellence and direction. We are looking for a senior technology leader seeking to utilize their technical leadership skills and expertise to immediately make a difference in building futuristic digital solutions. Among other responsibilities, s/he will architect the development of digital products/solutions using on premise technology, cloud technologies, SaaS or PaaS products or combining some or all of them as per solutions needs in support of the Commercialization and Enabling functions at Genmab. More...

This position will focus on Commercial, Medical Affairs, Compliance, Finance, HR, Legal and Operations with responsibility for supporting the core data and analytics needs of the functions within these areas. S/he will have overall accountability for the strategy, development, expansion and support of data products to create a modern workplace experience for all Genmab employees within these areas. Some additional responsibilities will include acting as custodians of data assets, to bridge the gap between data engineering and customer use cases by not only anticipating and meeting the needs of customers but also considering the data requirements, enterprise platforms, and architecture necessary to support these needs and establishing and developing effective business relationships with key business to ensure IT&D Data and Analytics can deliver data products that align with business strategies. More...

The preferred candidate will be a key player in Genmab’s global Precision Medicine function, part of the Translational & Quantitative Sciences organization. S/he will be the driving force behind translational research, playing a pivotal role in advancing the development of groundbreaking antibody therapeutics for cancer treatment. The goal is simple: Bring the right treatment to the right patient, at the right time. The individual’s mission will be to lead internal projects and external collaborations to steer our clinical programs. Some responsibilities include implementing Translational Medicine and biomarker strategies for clinical-stage oncology compounds; driving focused analyses of clinical and translational data, using your findings to shape the strategy of clinical programs and boost the success of our clinical trials; and building and cultivating relationships with external partners, overseeing timelines and deliverables for research collaborations. More...

Incumbent will be responsible for troubleshooting, operating and qualifying the validated computer systems for the shopfloor and process automation systems. Candidate must have MAB production experience and automation troubleshooting experience in Rockwell or Delta V. This role ensures reliable operation and implementation of all automation systems for a 24x7 commercial manufacturing facility. S/he works with the Senior Automation Engineers, with supervision and direction from them, and will provide technical support, commissioning support and SME knowledge in MAB unit operations. Some responsibilities will include supporting the design, development and qualification of automated processes, equipment and systems and identify opportunities to improve existing processes, equipment, systems and infrastructure; reviewing technical documentation; supporting of various Control System hardware and software; and directly supporting operations with troubleshooting and providing issue resolution with respect to computer and automation systems. More...

Some of the responsibilities for the qualified candidate will include building the DS organization with 50% of time focused on Production Shopfloor and 50% on administration work during Phase 1; leading commercial production according to schedule for the Phase 1 project timeline; overseeing Equipment FAT/SAT/IOQ/ and commissioning maintaining established timelines; establishing and improving DS quality assurance management system; establishing and implementing production file system as well as organizing and supervising the operation of production quality system; and staffing, training, instructing and managing Phase 1 construction of DS and leading production teams in DS workshops, as well as coordinating effective communication and cooperation among units relating to production and to ensure the successful completion of production and release of BDS. More...

Candidate will be responsible for maintaining a stable, qualified and highly available computing infrastructure and implementation and validated computer systems for the shopfloor and process automation systems, in close collaboration with the Global Technology Solutions (GTS) team. S/he will ensure reliable operation and implementation of all automation systems for a 24x7 commercial manufacturing facility. Incumbent will work independently, with minimal supervision and direction and will provide technical direction, Project Management support, Commissioning and SME expertise in the areas of Facility, Utility and Metrology, instrumentation /control services. Projects may often require independent decision making and exercising judgment. This role will be based in Hopewell NJ and report to the Site Director Facilities and Engineering or Senior Automation Engineer. More...

Some responsibilities for this position will include executing PAT related manufacturing activities in accordance with cGMP documentation and in compliance with GMP and HSE guidelines and documents, and internal and external policies and procedures (COPs, HBR, SOPs and others); carrying out assigned tasks and duties in a safe manner, in accordance with instructions, and comply with environmental, health & safety rules/procedures, regulations and codes of practice; suggesting, developing and implementing process analytical tools to enable process monitoring and assessment of product quality; overseeing and qualifying the implementation of these tools in the manufacturing assets in compliance with legislation and regulatory standards of Quality, HSE and cGMP policies; and promoting scientific excellence and innovation in the area of Modelling and PAT and contributing with technical expertise to expand the Intellectual Property, product and technology portfolios. More...

Candidate will have responsibility over strategic projects defined within Hovione portfolio that are executed throughout the Hovione sites worldwide. The individual will ensure the proper processes are in place and the necessary governance is well maintained on the projects under his/her responsibility. Incumbent will work with the projects teams to define the engagement with external EPC/EPCm partners and ensure the proper process and communications to run such projects; and review large projects (> 1M) that have been identified as carrying risk and propose improvement recommendations and/or support (when required) to bring these projects back on track. S/he will participate in dedicated Steering Committees of the projects under his/her responsibility. More...

Candidate will be responsible for applying expertise in a scientific or highly technical area of specialty as an individual contributor or through contributing to/managing project teams in order to achieve results. Some responsibilities will include providing leadership to teams through subordinate managers or through complex matrix relationships; managing the performance and results of multiple (or complex regional) teams; developing departmental plans, defining priorities and allocating resources to meet objectives and annual plan; integrating work across units, looking for ways to continuously improve performance of the department; identifying and solving complex problems leveraging the appropriate resources within or outside the department; and actively engaging and providing professional support to project teams in the areas of Project Controls. More...

Incumbent will be a key contributor in the reporting, forecasting and budgeting cycles for the CARVYKTI manufacturing program (US & EU). S/he will be responsible for partnering with the business to build robust financial models and keep detailed assumptions pertaining to planning cycles and project analysis. Candidate will work closely with all functional areas within Technical Operations, Quality and Procurement. Some responsibilities will include participating in the Long-Range Financial Plan (LRFP) and owning the financial modeling for gross margin analyses and improvement over the short, medium and long term; contributing to the Global Competitiveness Program as an active member of the Finance group; and partnering with business to develop business cases related to investments and cost improvement initiatives. More...

This role will be responsible for performing training and process improvement projects for the Gown Training Program. S/he is responsible for quality and maintaining the highest standards in compliance within company policies, procedures and all applicable regulations. Some responsibilities will include supporting and leading the Gowning Training Program; gowning training and qualification of Manufacturing, Quality (QA) and Quality Control (QC) associates for the production of autologous CAR-T products for clinical and commercial operation in a controlled current Good Manufacturing Practice (cGMP) cleanroom environment; supporting Gowning Training Associates with the execution of Instructor Led Trainings (ILT), Qualifications and Requalification of Raritan CAR-T personnel; and executing manufacturing gowning activities to support cell culturing, purification, aseptic processing and cryopreservation using appropriate gowning techniques. More...

This is an exempt level position responsible for reviewing all data produced by the Quality Control Lab during In-Process and release Drug Product QC Testing, related to the manufacturing of cell therapy products for clinical trials and commercial operations in a controlled GMP environment. Some responsibilities will include performing peer review/approval of laboratory data, including but not limited to eLIMS Electronic Notebooks, laboratory formbooks, training formbooks, instrument logbooks and records; utilizing electronic systems (LIMS) for execution and documentation; creating, reviewing and approving relevant QC documents, SOP’s and WI’s; performing tasks in a manner consistent with the safety policies, quality systems and cGMP requirements; and immediately alerting supervisor/manager when data discrepancies are identified. Job duties performed may occasionally require exposure to and handling of biological materials and hazardous chemicals. More...