- 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. (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)
- …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
- 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
- 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
- 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
- Lilly (Pleasant Prairie, WI)
- …driving solutions that impact the site and align with corporate objectives. The Associate Director , Quality Assurance, will also provide computer system ... production. This role will leverage a deep understanding of GMP data flows (electronic and paper), the application of...impact the site and align with corporate objectives. The Associate Director , Quality Assurance, will… more
- Lilly (Indianapolis, IN)
- …at multiple scales as well as high potency antibody drug conjugates. Associate Director for Small Molecule Process Quality will lead the team responsible for ... capital project deliveries is highly desirable. + Strong knowledge of the current GMP expectations and application of quality management systems in execution.… more
- Lilly (Lebanon, IN)
- …clinical trial medicines, while also reducing costs and environmental impact. The Associate Director , Plant Engineering provides leadership and direction to the ... the site FUME (Facilities, Utilities, Maintenance & Engineering) organization. The Associate Director , Plant Engineering ensures that area engineering,… more
- Lilly (Branchburg, NJ)
- …to make life better for people around the world. Eli Lilly and Company seeks a Quality Assurance Associate Director (M2) to provide quality direction for ... complex day not to-day quality activities and technical challenges ensuring GMP compliance. Partner with the business to resolve critical and complex compliance… more
- Merck (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
- Lilly (Durham, NC)
- …who are determined to make life better for people around the world. The Associate Director - Quality Engineering is responsible for demonstrating leadership, ... teamwork, and quality and regulatory knowledge to lead the ...utilities, and equipment. The position is essential for ensuring GMP compliance in the design, delivery, verification, qualification, start… more
- Lilly (Lebanon, IN)
- …to start-up, and to steady-state operations. The Laboratory Management and Operations Associate Director position seeks a collaborative, inclusive, and energetic ... and team activities are aligned with all relevant development quality , regulatory, HSE, GLP and GMP requirements....relevant development quality , regulatory, HSE, GLP and GMP requirements. **Basic Requirements:** + BS or MS in… more
- Lilly (Lebanon, IN)
- …to enable a successful startup into GMP manufacturing operations._ **Responsibilities** The Associate Director - Head of TS/MS Lab will lead a technically ... development. In this role you will work collaboratively with peers in the quality control laboratory, engineering, development and quality assurance. + Assisting… more
- Fujifilm (Holly Springs, NC)
- **Position Overview** The Associate Director , QA for Materials, Supply Chain and QC will be responsible for the supervision of the Quality teams supporting ... of materials, Supply Chain functions including warehouse as well as providing Quality oversight for the QC function via supervision ensure that materials released… more
- Catalent Pharma Solutions (Harmans, MD)
- ** Associate Director , Validation & Engineering** Catalent Pharma Solutions is looking to hire a ** Associate Director , Validation & Engineering** to lead ... and will house 8 CGMP manufacturing suites and cold storage warehousing. The ** Associate Director , Validation & Engineering** is responsible for the strategic… more
- Lilly (Indianapolis, IN)
- …audits and privacy related inspections, working in collaboration with Computer Systems Quality Assurance on GMP related systems. Also responsible for privacy ... + 10+ years experience working in a regulated industry (ie GMP ) and strong understanding of quality processes in IT applying to manufacturing and distribution. +… more
- Takeda Pharmaceuticals (Round Lake Beach, IL)
- …role:** At Takeda's Round Lake aseptic fill/finish and Packaging facility, the Associate Director , Process Engineering will lead a cross-functional team ... closely with Manufacturing, Maintenance, Automation, Reliability, Validation, Manufacturing Science, Quality , Business Excellence and Supply Chain to ensure operational… more
