- Exela Pharma Sciences, LLC (Lenoir, NC)
- …years' experience in the biotech/pharmaceutical industry in validation, quality management, process controls, and continuous improvement in an FDA -regulated ... Serve as a technical resource to improve product quality, reliability, and process capability. Support manufacturing to satisfy the quality and process … more
- Tris Pharma (Monmouth Junction, NJ)
- …in Monmouth Junction, New Jersey, Tris has an immediate opening for a Manager , Quality Management Systems (QMS). Summary:The Manager , Quality Management Systems ... current Good Manufacturing Practices (cGMPs), Food and Drug Administration ( FDA ) standards and batch record specifications.The incumbent uses systems thinking… more
- Lundbeck (Dallas, TX)
- …lead the way in creating positive customer experiences!As a BioPharmaceuticals Account Manager , you lead the promotion of our infusion product, driving demand ... and regulatory environment, including Lundbeck policies and procedures and FDA regulations regarding the promotion of pharmaceutical and medical products.… 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting data to support ... Affairs. Other relationships may include Convention Marketing and Sales Training. The Manager may represent Medical on PRB working group, brand teams/extended brand… more
- Lundbeck (College Station, TX)
- …transform lives. Join us on our journey of growth!As a Psychiatry Account Manager , you lead the promotion of our psychiatry portfolio, executing sales and marketing ... accountability and adherence to Lundbeck policies and procedures and FDA regulations regarding the promotion of pharmaceutical and medical products.REQUIRED… 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 ... management on trending and status as requested. Identify and implement process improvements related to investigations cycle time, closures, quality, and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Manager on SA deliverablesParticipates in departmental and cross-functional process improvement initiatives, as required.In-house office position that may require ... centered around rare diseases and immune disorders. Job Summary The Study Associate Manager , under the guidance of the Associate Director, will supervise a group… more
- Lundbeck (Oakland, CA)
- …transform lives. Join us on our journey of growth!As a Neuroscience Account Manager , you lead the promotion of our psychiatry portfolio to Psychiatrist and ... accountability and adherence to Lundbeck policies and procedures and FDA regulations regarding the promotion of pharmaceutical and medical products.REQUIRED… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Support the data collection for the Sales and Operations Planning (SOP) process .Execute the processes required to update information regarding purchase and ... process order status, by coordinating cross-functional activities with Finance,...materials management preferred1 or More Years of knowledge of FDA requirements preferredAbility to travel up to 20% Primary… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …performance and other areas. You will report to the Manager , Microbiology.Job ResponsibilitiesProvide general oversight, plan, organize, direct, and evaluate ... the implementation and interpretation of applicable quality and regulatory requirements (eg, FDA , GLP, QSR, cGMP, USP, and CDR rules, and guidelines), and ensure… more
- Merck & Co. (Durham, NC)
- …support this expansion. Project activities requiring support include the process and technology introduction, compliance improvements, and manufacturing readiness to ... approach to problem solving, and be self-motivated to identify and lead process improvement projects. - Position Responsibilities Could Include: Reporting to the… more
- Novo Nordisk Inc. (Durham, NC)
- …and scheduling experience for this area is a plus. Relationships Manager . Essential Functions Execute production plans by leading the operation, monitoring ... safety, quality, staffing or personnel issues & escalate to manager as may be necessary Monitor performance & completion...performing as an operator in the designated work cell process (es) Follow all safety and environmental requirements in the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …planning and execution of clinical studies, under the supervision of the Study Manager role the Study Associate Manager within Clinical Operations, in adherence ... appropriate Standard Operating Procedures (SOPs), Food and Drug Administration ( FDA ) regulations/EU Directive, and International Conference on Harmonization (ICH)… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and information from established internal contacts; consults with Supervisor/ Manager for decisions outside establishedprocesses.Provide guidance to other employees ... compliance, clinical quality, or cell therapy.Knowledge of cGMP regulations and FDA /EU guidance related to GMP manufacturing of biopharmaceutical. Experience in… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …will be commisserate with experience. Relationships Reports to: Automation Manager Essential Functions Responsible for assisting with the design, implementation, ... following is desired: Microsoft Windows Operating Systems and Networking systems (Ethernet) FDA and EMEA Regulatory requirements Experience at a medium to large… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …Releases product based on Quality Assurance record review and approval by QA Manager Performs regular internal audits of NNUSBPI facilities as a lead auditor Works ... a licensed drug or biologic facility regulated by the FDA , EMEA or a leading international regulatory agency preferred...of identifiable factors We commit to an inclusive recruitment process and equality of opportunity for all our job… more
- Mentor Technical Group (College Station, TX)
- …provides a comprehensive portfolio of technical support and solutions for the FDA -regulated industry. As a world leader in life science engineering and technical ... Functions: + Provide engineering, troubleshooting support and technical expertise for process equipment and site utilities as needed. + Proactively identify… more
- Vera Therapeutics (Brisbane, CA)
- Title: Senior Manager , Process Development, Downstream Location: Brisbane, CA About Us: Vera Therapeutics (Nasdaq: VERA), is a late clinical-stage biotechnology ... treatment for patients suffering from immunological diseases. Position Summary: The Senior Manager , Process Development, Downstream will be responsible for all… more
- Teva Pharmaceuticals (Parsippany, NJ)
- * Manager , Regulatory Affairs Date: Apr 2, 2025 Location: Parsippany, United States, New Jersey, 07054 Company: Teva Pharmaceuticals Job Id: 61105 **Who we are** ... people to make a difference with. **How you'll spend your day** The Manager , Regulatory Affairs will: + Prepare, review and approve regulatory submissions (ie ANDAs,… more
