- Olema Oncology (San Francisco, CA)
- …patients feel better, longer. For more information, visit us at www.olema.com. About the Role Associate Director , GMP Quality Assurance As the ... Associate Director , GMP Quality Assurance, reporting to the Head of Quality Assurance, you will support the assurance of product quality … more
- Merck & Co. (Durham, NC)
- …any new projects.- This includes SME support during routine internal and external GMP and Financial audits, QSAT actions, to ensure compliance.- This is a fast-paced ... a wide range of business activities.- Reporting directly to the Director , Supply Chain Management, the successful candidate's primary responsibilities will include… more
- Merck & Co. (Rahway, NJ)
- …facility in Rahway, New Jersey.The Sterile Process Engineer role at the Associate Director level will leverage the individual's leadership, technical, and ... formulation and process development through process tech transfer, scale-up activities, quality investigations, change management, and authoring GMP standard… more
- Merck & Co. (Rahway, NJ)
- …data analytics/visualization software . - Familiarity with Good Manufacturing Practices ( GMP ) requirements, quality procedures, and Standard Operating Procedure ... a lead GCS Planning program representative ) such as clinical development, regulatory, quality and other supply chain areas to negotiate timelines ,- strategies and… more
- Eisai, Inc (Exton, PA)
- …production processes and technologies into the production suites.The Associate Director writes, reviews, and/or approves GMP documents, including validation ... your profile, we want to hear from you. The Associate Director of Biologics Operations Upstream and...Quality Control, Regulatory, and CMC Program Management departments.The Associate Director of Biologics Operations maintains knowledge… more
- Merck & Co. (Rahway, NJ)
- …portfolio. Within Biologics and Biopharmaceutics, the large molecule product development Director will influence the strategy, lead activities, and develop a team ... / our Research & Development Division ) such as Quality , Regulatory CMC, and technical functions, to ensure timebound...as well as advancing a culture of scientific excellence, GMP and compliance mindset and collaboration with various partners… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …to execute daily production schedules.Will have 3-6 direct reports ranging from Associate Director , Senior Manager, and Manager.Oversee the hiring, development, ... of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Director of Operations as part of the Technical Operations team based in Raritan,… more
- Merck & Co. (Durham, NC)
- …Manufacturing Operations, Drug Delivery Systems and Devices within our Manufacturing Division ( Associate Director ).-This role serves as a Virtual Plant Manager - ... contact for all dealings between our Company and the External Partner, the Associate Director External Manufacturing Operations is accountable for establishing a… more
- Merck & Co. (Rahway, NJ)
- …regulatory submissions.-Under the general scientific and administrative direction of the Director in Biologics Cell Culture Sciences group and working in conjunction ... a cross-functional team.-Ensures project results meet requirements regarding technical quality , reliability, schedule, and cost.Monitors performance and recommends schedule… more
- Merck & Co. (Durham, NC)
- …policies, procedures and business plan; receives guidance and oversight from Operations Associate Director and Director ;Interprets client and/or customer ... Regulatory Agency, and State and Local code requirements for quality , good manufacturing practices ( GMP ), equal employment...and any action plans to address gaps to the Associate Director and/or Director .- Identify,… more
- Bristol-Myers Squibb Company (Devens, MA)
- …our Cell Therapy team. Bristol Myers Squibb is seeking a driven and experienced Associate Director , Manufacturing and Process Support Innovation Lead to lead the ... implement transformational changes to improve overall patient throughput, product quality , and operational efficiency. Identify, adopt, and integrate advanced… more
- BioSpace (Thousand Oaks, CA)
- …the safe, compliant, and uninterrupted delivery of utilities to our 24/7 commercial GMP biologics manufacturing operations. Success is achieved by leading a team of ... and technicians in the operation, maintenance, repair, and improvement of GMP utility systems, including facility systems (eg, HVAC, electrical), high-purity water… more
- Bristol-Myers Squibb Company (Indianapolis, IN)
- …team, RayzeBio aims to be the global leader in radiopharmaceuticals. Summary The Associate Director of Chemistry, Manufacturing & Controls (CMC) - Quality ... other tasks as assigned (eg, final Quality reviewer/approver of Quality events and/or GMP documentation, actively contributes to ongoing investigations… more
- Eli Lilly and Company (Lebanon, IN)
- …When required (and per delegation procedure), in the absence of the Associate Director -Manufacturing provide continuity to the Process Team activities and ... to build the processes and facility to enable a successful startup into GMP manufacturing operations. The Manufacturing Operations Associate (OA) for the Lilly… more
- BayOne (Raleigh, NC)
- …Friday, from 8:00 to 5:00, 3 days a week in the Raleigh office The Associate Director , Quality Assurance, is responsible for the global strategic management ... Management and Oversight Responsible for the global strategic oversight of R&D Quality GMP activities as related to Medical Devices (non-EBD and EBD) in support… more
- Sotera Health Services, LLC (Grand Prairie, TX)
- …Manager. Additionally, they will be a technical representative for the Sterigenics' Director of Validations. In that role, they will be responsible for helping ... effectively interface with Sales, Operations, Corporate EO Technology, Laboratory, EHS, Quality , Engineering and other Sterigenics' facilities, as well as customers… more
- Coyote Technical Executive Sourcing, LLC (Norco, CA)
- … GMP , Allergens, SOPs, Pre-Op, prerequisite programs) Qualifications: *Experienced Quality Control Manager to ensure the production lines generate a consistently ... and written English required Certification programs in Six Sigma, Quality Improvement associate , ISO, quality ...references to: COYOTE TECHNICAL & EXECUTIVE SOURCING Phil Montoya Director of Sourcing Quality Control Manager (Food… more
- Jeeter (Desert Hot Springs, CA)
- …is very passionate about producing world-class marketing, high quality , innovative products, delivering unprecedented customer experiences, having cutting-edge ... for supervising and coordinating production activities to ensure consistent output, quality , and compliance with industry regulations. In this role, you will… more
- Shearer's Foods (Brewster, OH)
- …facilities in Massillon, Ohio. The Company is known for producing the highest quality snacks in assorted flavors and sizes, including kettle cooked potato chips, ... within the plant. This position reports to the Plant Director . What you bring to the party: Direct the...procedures, and regulations including OSHA, FDA, SQF, AIB, EPA, GMP , NFPA, NEC and other code and regulatory agencies.… more
- Regeneron Pharmaceuticals (Rensselaer, NY)
- We are currently looking to fill an Associate Director of GMP Compliance & Inspections position. This position will work with cross-functional teams to drive ... activities that will ensure a state of continuous GMP compliance in Regeneron and to build inspection readiness...and ensure we are performing with in compliance. The Director will also provide support during regulatory inspections and… more
