- Tris Pharma (Monmouth Junction, NJ)
- …quality operations , etc. Responsibilities:Assures compliance with all SOPs, cGMP, FDA , as well as all applicable company compliance guidelines, standards and ... in Monmouth Junction, New Jersey, Tris has an immediate opening for a Manager , Quality Management Systems (QMS). Summary:The Manager , Quality Management Systems… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- Legend Biotech is seeking a Commissioning and Qualification Project Manager as part of the Technical Operations team based in Raritan, NJ. Role OverviewThis ... systems within cell therapy manufacturing. The Commissioning and Qualification Project Manager will develop and manage all aspects of the qualification program… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- Legend Biotech is seeking an Investigations Manager as part of the Technical Operations team based in Raritan, NJ. Role OverviewThe Manager of CAR-T ... Investigations will be part of the Operations Investigations team and will be responsible for managing and leading different investigations work-cells, drive… more
- Novo Nordisk Inc. (Boulder, CO)
- …for patients. The Position Novo Nordisk is seeking a Quality Control Manager to support the successful start-up of the Quality Control laboratory supporting ... phase 1 and 2 oligonucleotide drug substance manufacturing. The QC Manager position will manage all activities related to the establishment & operation of the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …centered around rare diseases and immune disorders. Job Summary The Study Associate Manager , under the guidance of the Associate Director, will supervise a group ... appropriate Standard Operating Procedures (SOPs), Food and Drug Administration ( FDA ) regulations/EU Directive, and International Conference on Harmonization (ICH)… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for Global requests. Support the data collection for the Sales and Operations Planning (SOP) process.Execute the processes required to update information regarding ... planning and/or materials management preferred1 or More Years of knowledge of FDA requirements preferredAbility to travel up to 20% Primary travel to domestic… more
- Formation Bio (New York, NY)
- …and resource allocation. Ensure all clinical trials comply with ICH-GCP, FDA regulations, and other applicable regulatory standards. Champion proactive risk ... high standards of quality, cost control, and on-time deliverables. Serve as the Operations Lead for clinical assets, programs, and studies. Step in as the Clinical… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- The QC Microbiology Supervisor leads, and monitoring the daily operations , activities, and workflow for the laboratory personnel. Additionally, you will implement ... performance and other areas. You will report to the Manager , Microbiology.Job ResponsibilitiesProvide general oversight, plan, organize, direct, and evaluate… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …under the supervision of the Study Manager role the Study Associate Manager within Clinical Operations , in adherence to the protocol, Good Clinical Practices ... appropriate Standard Operating Procedures (SOPs), Food and Drug Administration ( FDA ) regulations/EU Directive, and International Conference on Harmonization (ICH)… more
- Merck & Co. (Durham, NC)
- …skills as a member of a multidisciplinary team supporting the operations of pharmaceutical, biologic, and/or vaccine manufacturing facilities. The successful ... objectives. Consults on an as-needed basis with next level manager on more complex decisions. Executes critical site review...two (2) years of experience in an GMP or FDA regulated industry. -Schedule: Monday - Friday, 6:00 AM… more
- Catalent Pharma Solutions (Harmans, MD)
- ** Manager , Manufacturing Technical Operations (MTO)** **Summary:** _Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) ... including AAV and other viral vector-based therapies and vaccines._ The ** Manager , Manufacturing Technical Operations (MTO)** is responsible for oversight… more
- Boehringer Ingelheim (Ridgefield, CT)
- …processes + Based on organizational need supervise assigned RA Product Labeling Operations staff members **Duties & Responsibilities** + Actively lead the execution ... role for ad hoc project assignments where DRA Product Labeling operations representation is needed. + Independently communicate via established procedures with… more
- Abbott (Alameda, CA)
- …levels with our new sensing technology. **The Opportunity** This **Regulatory Affairs Manager - International Compliance Operations ** will work on-site at our ... their glucose levels with our new sensing technology. This **Regulatory Affairs Manager - International Compliance Operations ** will provide support for the… more
- Cambrex High Point (Longmont, CO)
- …that all activities are in compliance with company SOPs, cGMP/cGLP standards and FDA /EU regulations. The Manager of Quality Assurance leads and mentors the ... where You Matter by applying today! Job Overview The Manager of Quality Assurance is responsible for the daily... of Quality Assurance is responsible for the daily operations of the Quality Assurance team in a CDMO… more
- Takeda Pharmaceuticals (Boston, MA)
- …company to inspire you and empower you to shine? Join us as a Manager , Global Import & Export Operations and Trade Compliance based in Cambridge, ... to our inspiring, bold mission. **_GOALS:_** + The Global Trade Compliance Manager will ensure that Research & Development imports and exports are conducted… more
- Cardinal Health (Indianapolis, IN)
- …treatment through disease diagnosis, staging, and monitoring. **_Job Summary_** The Manager , Plant Operations manages/coordinates teams and processes across ... multiple operational areas in an FDA regulated facility. This job plans and prepares strategic...each client project to fit within facility capability. The Manager , Plant Operations ensures safe and compliant… more
- Glenmark Pharmaceuticals Inc., USA (Monroe, NC)
- Aseptic Operations Manager Department: Operations Plant Head Location: Monroe, NC START YOUR APPLICATION ... for other production areas during leadership absences. OVERALL JOB RESPONSIBILITIES: Operations Excellence: - The Aseptic Manufacturing Manager is responsible… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …company to inspire you and empower you to shine? Join us as a Manager , Global Clinical Supply Chain Import/Export Operations based in Cambridge reporting to ... the Senior Manager , Global Clinical Supply Chain Import/Export Operations . At Takeda, we are transforming the pharmaceutical industry through our R&D-driven… more
- Colgate-Palmolive (Sanford, ME)
- …common goals. Together, let's build a brighter, healthier future for all. **The Operations Manager is responsible for overall management of the manufacturing ... coaching and feedback, effective resource utilization and visible team leadership. The Operations Manager will lead this integral function from a Supply… more
- IQVIA (Brooklyn, NY)
- …are seeking successful, qualified, experienced individuals to join our team of CAR-T Field Operations Managers. This team is part of an exciting new era in CAR-T ... Provide customers with the educational resources and requirements for end-to-end CAR-T operations needs + Provide training on appropriate handling, and scheduling +… more
