- Legend Biotech USA, Inc. (Raritan, NJ)
- …of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking a Quality Systems Lead as part of the Quality team based in Raritan, NJ. Role ... OverviewThe Quality Systems Lead role is an exempt level...exempt level position with responsibilities for supporting the quality systems processes within a cell therapy manufacturing… more
- Merck & Co. (Rahway, NJ)
- …requirements for sterile drug products, as well as combination product assembly processes .Extensive knowledge of US and global medical device and healthcare ... and knowledge of product and process development in the (bio)pharmaceutical and medical device industries to set tactical and strategic direction on programs to… more
- BioAgilytix (Durham, NC)
- …go-to person for everything related to data. You'll build the rules, processes , and cloud pipelines that keep lab and business information accurate, secure, ... access control, and compliance protocols.Define standards, build quality assurance processes , and monitor data integrity to meet regulatory requirements, including… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …systems across the organization. This position ensures that all global systems , electronic records, validation processes , and regulated applications meet ... pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and… more
- Eisai, Inc (Nutley, NJ)
- …scientific exchange materials in partnership with Medical Information Managers and Medical Directors for CRC and MRC processes for assigned products and/or ... At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides...within the department and cross-functionally. May serve as project lead to develop and update AMCP Formulary Dossiers for… more
- Eisai, Inc (Cincinnati, OH)
- …Investigators involved in company sponsored post-marketing studies. Professional Organization Support Lead field medical efforts in support of Eisai's ... At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides...congresses in accordance with MSL plan. Be prepared to lead congress coverage efforts, including coordination of all MSL… more
- Aequor (Devers, TX)
- …. Ensure all timelines and milestones for the project are met. Consistency in Processes : Lead consistent site and global ways of working. Change Management: ... High Possibilities of ExtensionDescriptionThe Cell Therapy SAP Sourcing Migration Lead is located in Devens, Massachusetts. This role will... medical device industry Min 4 yrs exp with Procurement UAT, Training others on ERP systems , and… more
- Novo Nordisk Inc. (Durham, NC)
- …Department For more than 100 years, Novo Nordisk has been tackling the unmet medical needs of people living with serious chronic diseases, such as diabetes & ... 14 weeks paid parental & 6 weeks paid family medical leave Free access to Novo Nordisk-marketed pharmaceutical products...us make what matters. The Position Serve as a Lead & Subject Matter Expert (SME) to provide technical… more
- Merck & Co. (Durham, NC)
- …and versatile leader for External Manufacturing Operations, Drug Delivery Systems and Devices within our Manufacturing Division (Associate Director).-This role ... and test complex injection molded Device Components, Device Constituents, and Medical Devices used to deliver Pharmaceutical, Biologic, and Vaccine Products. Our… more
- Merck & Co. (Rahway, NJ)
- …Engineering Standards, Environmental Health and Safety (EHS) Management, HVAC Systems , Identifying Risks, Maintenance Processes , Management Process, Programmable ... through statistical techniquesDeveloping and implementing data analyses, data collection systems and other strategies that-optimize-statistical efficiency and quality.Develop and-maintain-Site… more
- Merck & Co. (Rahway, NJ)
- …to enhance the efficiency, accuracy, and effectiveness of clinical supply planning processes and systems . - Stay updated on industry trends, regulations, ... and external to GCS and serve s as the lead GCS spokesperson at clinical and development related meetings...relationship management. - Technical Proficiency: familiarity with supply chain systems and software ( eg SAP or Oracle) and… more
- Repligen (Rancho Dominguez, CA)
- …Act as a Subject Matter Expert for TFF and other bioprocessing manufacturing systems . Lead projects in equipment design, tech transfer, process validation, and ... are seeking a highly motivated and experienced Senior Engineer to lead multi-product project execution, manufacturing support, and technology transfer efforts at… more
- Merck & Co. (Rahway, NJ)
- …The role is on-site and reports to the Sterile Pharm Ops Engineering Lead of the FLEx GMP facility within Pharmaceutical Operations and Clinical Supply (PSCS)The ... and Validation plans around equipment, critical utilities, and computer systems .- Prepare and approve qualification protocols and summary reports.- Execute… more
- Lundbeck (Fort Wayne, IN)
- …transform lives. It's a very exciting time to join our team as we lead the way in creating positive customer experiences! As a BioPharmaceuticals Account Manager, ... you lead the promotion of our infusion product, driving demand...Payer Access -Ability to grasp sophisticated reimbursement and distribution processes in a complex coverage landscape. Anticipates and communicates… more
- Insmed Incorporated (San Diego, CA)
- …inspections is required.Experience developing SOPs, reviewing internal clinical, regulatory and medical processes to ensure they are accurately represented in ... and regulatory compliance related to GCPs, acts as quality lead on the gene therapy clinical development team, and...provides support and promotes collaboration internally to ensure all systems , processes and their outcomes comply with… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and ensure safe and compliant manufacturing operations according to cGMP requirements. Lead a ~250+ organization responsible for either the non-sterile or sterile ... manufacturing processes in a 24/7 operation and be responsible to...and maintain permanent inspection readiness and actively support regulatory inspections. Lead facility operating review meetings and sponsor various department… more
- Merck & Co. (Rahway, NJ)
- …Downstream Purification-department is seeking a passionate and skilled individual to lead the charge in transforming our late-stage pipeline and commercial products ... reality.What You'll Do:As a key player in our BDSC team, you will: Lead and Collaborate: Participate in and/or spearhead cross-divisional technical teams focused on… more
- Merck & Co. (Rahway, NJ)
- …its' Performance Qualification and Process Simulation execution, the selected candidate will lead and contribute to the launch and regulatory certification of the ... of the clinical supplies, the scientific rigor of the processes , and ultimately to enable the flexibility and speed...New Jersey and reports to the Sterile Process Engineering Lead of the FLEx GMP facility within Pharmaceutical Operations… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …of IT security strategy and serving as a security advisor to ensure IT systems are implemented and maintained to the highest security standards. Individuals in this ... Assists in leading a project in the development and implementation of processes and programs Leverages knowledge of topics such as networking, operating … more
- Merck & Co. (Upper Gwynedd, PA)
- …packages and responses to health authority questions per established business processes and systems .-Identify, communicate and escalate potential regulatory ... include, but are not limited to:Regulatory Responsibilities: Serve as a CMC Product Lead for assigned products and be accountable for the delivery of all regulatory… more
