- Aequor (Pearl River, LA)
- …(Clarification and Purification) and buffer preparation areas of the cGMP commercial manufacturing facility. Requires good documentation skills and attention ... in execution and reviews of production records. Responsible for all required cGMP training including additional training assigned by their manager. Participates in… more
- Merck & Co. (Durham, NC)
- …Experience and Skills: Experience in vaccine or biologics manufacturing within a cGMP environment Experience authoring technical documentation within a cGMP ... in bulk upstream and/or downstream vaccine processes within a cGMP environment Experience in manufacturing support processes including media development/manufacture… more
- Merck & Co. (Durham, NC)
- …value to the achievement of team goalsUnderstand and apply cGMP /GLP, Compendial, and other applicable regulatory requirements toward analytical testingCapability ... Specialist, Quality Control will be responsible for activities that support cGMP and regulatory compliance during method qualification/validation and routine product… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …clinical and commercial requirements in either a Grade C or sterile cGMP environment.Key Responsibilities Oversee cell therapy production 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… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …will be responsible for maintenance support and mechanical system operations for cGMP Clinical and Commercial Cell Therapy Manufacturing on a modified second shift ... therapy production through safe and compliant manufacturing operations according to cGMP requirements. This individual will support the organization in its build… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …personalized cell therapy to support both clinical and commercial requirements in a sterile cGMP environment. Job duties will be performed within a team based on an ... a manner consistent with safety policies, quality systems, and cGMP requirements.Build strong partnerships with Manufacturing, Warehouse, Engineering, and Quality,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and follow standard operating procedures and work instructions and comply with cGMP regulations and safety guidelines.Key Responsibilities Serve as a subject matter ... standard operating procedures and work instructions and comply with cGMP regulations and safety guidelines.Establish key stakeholder relationships with internal… more
- Merck & Co. (Durham, NC)
- …vaccines work environmentCommunication, leadership and teamwork skillsPreferred Experience and Skills: cGMP experience in a sterile bulk, biologics or pharmaceutical ... ApplicableShift:1st - DayValid Driving License:NoHazardous Material(s):N/ARequired Skills:Adaptability, Biopharmaceutical Industry, cGMP Compliance, Communication, Computer Literacy, Data Analysis, Environmental Health… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …NJ. Role OverviewThis position will be responsible for metrology support for cGMP Clinical and Commercial Cell Therapy Manufacturing. This individual will partner ... therapy production through safe and compliant manufacturing operations according to cGMP requirements. This individual will support organization build and ramp-up of… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …for performing training activities for Operations team members who support cGMP Clinical and Commercial Cell Therapy Manufacturing. This individual will partner ... cell therapy production through safe and compliant operations according to cGMP requirements. This individual will support organization build and ramp-up of… more
- Aequor (Swiftwater, MN)
- …timely manner, while strictly adhering to company policies and procedures and cGMP . JOB RESPONSIBILITIES: Perform QC testing while strictly adhering to company ... policies and safety procedures, SOP/SWI, Pharmacopeia, Federal Regulations, cGMP , and required training curricula. Perform all scheduled activities defined by… more
- Eisai, Inc (Exton, PA)
- …and efficiency of upstream and downstream production suites in a cGMP biopharmaceutical pilot plant, including scheduling of staff, preparation and close-out ... providing data for regulatory documents as required.7. Ensure adherence of operations to cGMP , ICH, EMEA, and JP Guidelines as well as industry safety standards and… more
- AUROBINDO (Durham, NC)
- …relating to the ware house department as requested.Follow company policies, cGMP 's, safety and Standard Operating Procedures. Qualifications - Skills & ... written instructions precisely and perform basic math calculation.Understanding/knowledge of cGMP , safety criteria or the ability to learn.Basic computer… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …manner consistent with the safety policies, quality systems, and cGMP requirements.Drive continuous improvementOther duties may be assigned, as ... quality assurance, manufacturing compliance, clinical quality, or cell therapy.Knowledge of cGMP regulations and FDA/EU guidance related to GMP manufacturing of… more
- Insmed Incorporated (San Diego, CA)
- …validation according to regulatory guidelines such as ICH, FDA, and cGMP , evaluating method characteristics like specificity, sensitivity, accuracy, and precision. ... techniques and instrumentation is necessary, as is knowledge of regulatory guidelines like cGMP and ICH, and data integrity principles such as ALCOA. Strong data… more
- Aequor (Hicksville, OH)
- …Participates in training of new employees. Adheres to all applicable procedures, cGMP 's, company policies, and all other quality or regulatory requirements (OSHA, ... to maintain a high level of activity, as well as the use of a pallet jack. Knowledge of cGMP and SOP procedures for filling and packaging of pharmaceutical products more
- Aequor (Hicksville, OH)
- …pallet jacks in a timely manner, observing all safety regulations and ensuring all cGMP and quality standards are met and to maintain the efficient flow of product ... and perform inventory adjustments. Major Accountability: Possesses required knowledge of SOP's, cGMP 's, procedures, SAP entries and has the ability to explain the… more
- Aequor (Houston, TX)
- …determine the most likely cause of the deviation investigation o Familiarity with cGMP quality systems, and demonstrates ability to read and comprehend GMP documents ... the most likely cause of the deviation investigation Knowledge Familiarity with cGMP quality systems, and demonstrates ability to read and comprehend GMP documents… more
- Insmed Incorporated (San Diego, CA)
- …process development, optimization, technology transfer, and process characterization of cGMP processes for viral vectors.Take responsibility for the design and ... vector purification process development.Demonstrated understanding of process development and cGMP production operations.Experienced in early stage clinical to commercial… more
- Merck & Co. (Rahway, NJ)
- …global medical device and healthcare regulations, including FDA combination products cGMP , Quality System Regulation, FDA Human Factors guidance, ISO 14971, 11608 ... and 11040, EN 62366, Council Directive 93/42/EEC, etc.-Additionally possess extensive knowledge in traditional worldwide pharmaceutical regulations including but not limited to 21CFR210, 211, 600-680, ICH Q8/9/10, Directive 2001/83/EC and comparable worldwide… more
