- Legend Biotech USA, Inc. (Raritan, NJ)
- …therapy process development, manufacturing science, analytical development, and familiarity with GMP / FDA /ICH .Key Responsibilities Subject matter expert of QC ... shift in throughput and capacity Maintain current awareness of GMP /GLP/GCP/GDP, ICH, USP, and FDA guidelines, industry...current awareness of GMP /GLP/GCP/GDP, ICH, USP, and FDA guidelines, industry standards, and trends that apply to… more
- Novo Nordisk Inc. (Boulder, CO)
- …management experience A deep understanding of and ability to apply of GMP /ICH/ FDA regulations to process development strategies for Oligonucleotide based drugs ... The base compensation range for this position is $150,000 to $185,000. Base compensation is determined based on a number of factors. This position is also eligible for a company bonus based on individual and company performance. Novo Nordisk offers long-term… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of the 8 years must include MSAT experience.Knowledge of cGMP regulations and FDA /EU guidance related to GMP manufacturing of biopharmaceuticals. Experience in ... plant to support both clinical and commercial requirements in a sterile GMP environment. This role will also provide oversight of technical operations activities… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …compliance, clinical quality, or cell therapy.Knowledge of cGMP regulations and FDA /EU guidance related to GMP manufacturing of biopharmaceutical. Experience ... in supporting cell-based products as well as knowledge of Good Tissue Practices is a plus.Strong interpersonal and written/oral communication skills.Ability to quickly process complex information and often make critical decisions with minimal… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …presented in a manner that facilitates Health Authority reviews.- Supports company`s GMP Change Management Program. Evaluates CMC changes for portfolio biologics and ... of CMC changes and assess regulatory implications.- Participates in meetings with FDA . Prepares internal functional teams for these interactions to build strong… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …Engineer is responsible for ensuring cGMP compliance of all relevant FDA regulations and internal procedures/specifications relating to oversight of engineering ... to document decisions and rationale. Data Integrity - assure GMP data captured and managed by engineering are handled,...Audits - represent the company during contact with the FDA and other regulatory agency audits. Data Management- perform… more
- Aequor (Thousand Oaks, CA)
- …safety, and 's Commissioning and Qualification Process (CQP) to ensure that new GMP equipment is installed and maintained in a validated state, equipment & ... experience in operations/manufacturing environment Direct experience with regulated environments ( FDA , OSHA, EPA, etc.) Working knowledge and experience with cGMP… more
- Insmed Incorporated (San Diego, CA)
- …for the QC stability and sample management operations in support of routine GMP operations at Insmed Gene Therapy. The ideal candidate will have commercial ... GMP experience in supporting stability and sample management programs.ResponsibilitiesRepresentative...development.Extensive knowledge of regulatory requirements and guidelines (ICH, CFR, FDA ) as they relate to drug substance and drug… more
- Merck & Co. (Durham, NC)
- …Technician include the execution of aseptic processing requirements, adherence to GMP (Good Manufacturing Practices), and working in a self-directed team environment ... - - Preferred Experience and Skills: - BioWorks Certificate (working in an FDA regulated industry). - - Our Manufacturing & Supply Division is committed to… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …absence.Assist management during internal and external regulatory audits (including FDA , EMEA)Establish key stakeholder relationships with internal and external ... facilities preferred.Experience with performing sampling/testing and execution of validation studies. GMP manufacturing and/or validation experience is preferred.Maintain processes at… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …documentation and records to certify compliance with in-house specifications/standards and GMP for all NNUSBPI products. This position has QA signature authority ... Work Experience: A minimum of five (5) years of GMP -related experience in a pharmaceutical or biotechnology company, with...a licensed drug or biologic facility regulated by the FDA , EMEA or a leading international regulatory agency preferred… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …to support both clinical and commercial requirements in a sterile GMP environment. This includes supporting and approving manufacturing investigations, ownership of ... compliance, clinical quality, or cell therapy Knowledge of cGMP regulations and FDA /EU guidance related to manufacturing of cell based products as well as… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …therapy products for clinical trials and commercial operations in a controlled GMP environment.Key Responsibilities Be responsible for the completion of QC testing ... is completed in compliance with all applicable procedures, standards and GMP regulationsWork with Process Development team, Quality and Operations organization to… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …cell therapy products for clinical trials and commercial operations in a controlled GMP environment. This position is primarily a M-F schedule, with potential nights ... is completed in compliance with all applicable procedures, standards and GMP regulations.Work with Process Development team, Quality and Operations organization to… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …QC, Facilities, MSAT, process engineering and other departments liable for GMP activities, to support investigation and resolution of deviations and other ... make recommendations based on data analysisMust be familiar with health authority ( FDA ) requirementsAbility to work in a fast-paced environment with the capability… more
- Merck & Co. (Rahway, NJ)
- …is expected, as well as advancing a culture of scientific excellence, GMP and compliance mindset and collaboration with various partners and stakeholders in ... options, technology selection and regulatory postureDemonstrated working knowledge of FDA , ICH, and other regulatory requirements for CMC.- Strong experience… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …products for clinical trials and commercial operations in a controlled GMP environment.Key Responsibilities Responsible for performing routine EM sampling, including ... room and biosafety cabinets is required.Knowledge of cGMP regulations and FDA /EU guidance related to manufacturing of cell-based products is required.Knowledge of… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …products for clinical trials and commercial operations in a controlled GMP environment.Key Responsibilities Perform peer review/approval of laboratory data including ... Control setting is preferred. Knowledge of cGMP and GDP regulations and FDA /EU guidance related to manufacturing of cell-based products is required. Detailed… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …support clinical trials and commercial operations in a controlled GMP environment.Major ResponsibilitiesResponsible for performing routine EM sampling, including ... room and biosafety cabinets is requiredKnowledge of cGMP regulations and FDA /EU guidance related to manufacturing of cell-based products is required.Knowledge of… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …products for clinical trials and commercial operations in a controlled GMP environment.Key Responsibilities Responsible for reviewing routine EM sampling, including ... room and biosafety cabinets is preferred.Knowledge of cGMP regulations and FDA /EU guidance related to manufacturing of cell-based products is required.Detailed… more
