- Legend Biotech USA, Inc. (Raritan, NJ)
- …therapy manufacturing plant to support both clinical and commercial requirements in a sterile GMP environment. This role will also provide oversight of ... in quality assurance, manufacturing compliance, clinical quality, or cell therapy.Knowledge of cGMP regulations and FDA/EU guidance related to GMP manufacturing… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …therapy manufacturing facility to support both clinical and commercial requirements in a sterile GMP environment. This role will serve as the business process ... quality systems processes.Ensure compliance with current Good Manufacturing Practices ( cGMP ).Manage multiple and complex cross-functional projects with many stakeholders.Support… more
- Thermo Fisher Scientific (Greenville, NC)
- …Schedule Other Environmental Conditions Adherence to all Good Manufacturing Practices ( GMP ) Safety Standards, Office, Some degree of PPE (Personal Protective ... of approximately 4400 colleagues across six sites who specialize in taking sterile injectable and oral solid dose drug products from development to… more
- Celularity Inc. (Florham Park, NJ)
- …support of clinical stage platforms and collaborations. Leveraging Celularity's state-of-the-art cGMP capable facility, this position will make use of existing ... and clean room suites. Ability to gown appropriately for clean room/ aseptic manufacturing is required. Work cohesively with cross-functional teams in support… more
- Fujifilm (Holly Springs, NC)
- … cGMP manufacturing environment OR *Equivalent Military training/experience *Prior cGMP experience from an aseptic pharmaceutical environment Preferred ... is responsible for Component/Parts Preparation, Thawing and Formulation of Drug Substance, Sterile Filling and Visually Inspecting of Drug Product (DP). This role… more
- Ceva Sant Animale (Verona, WI)
- …experience in cGMP laboratory experience preferred *Experience working in an aseptic production environment required *Experience in FDA- or EU- regulated GMP ... experience in cGMP laboratory experience preferred Experience working in an aseptic production environment required Experience in FDA- or EU- regulated GMP … more
- Thermo Fisher Scientific (Greenville, NC)
- …work experience may be considered. Knowledge, Skills, Abilities Knowledge of sterile operations including aseptic techniques, sterilization and compounding. ... lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices ( GMP ) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish,… more
- Kelly Services (West Chester, OH)
- …pharma/life sciences industry (healthcare or food manufacturing acceptable) + **Understanding of GMP / cGMP / sterile / aseptic production** - proven success ... drive success in this vital role. Looking for experience in pharmaceutical manufacturing with GMP experience. Temp to hire opportunity! Mon - Friday 1st shift - can… more
- Glenmark Pharmaceuticals Inc., USA (Monroe, NC)
- …aseptic cleaning, equipment preparation for sterilization, product pathway assembly, sterile filtration, aseptic filling and terminal sterilization. + ... Sterile Injectable Supervisor Department: Production Location: Monroe, NC...Degree preferred Experience: 5 - 7 Years- experience in CGMP / Aseptic Operations Background Knowledge & Skills: +… more
- Endo International (Rochester, MI)
- …all equipment in the department for the purpose of cleaning and disinfecting/sanitizing/fogging aseptic and non- aseptic GMP areas ▪ Maintains supplies and ... containers for sterile filling production waste. ▪ Documentation ▪ Documents GMP records, LUMAC logbooks and sanitation schedules, upon completion of daily work… more
- Endo International (Rochester, MI)
- …we serve live their best life. **Job Description Summary** The Supervisor, Sterile Filling is responsible for daily coordination and execution of working schedules ... of people and equipment in Sterile Filling. Responsible for supervising hourly union operators that...objectives. Responsible for direct supervision of one or more aseptic filling lines. Typically this will involve 3 to… more
- Merck (West Point, PA)
- …SPO Technician | Level 1 completes a wide variety of tasks and operations in GMP , aseptic and controlled environments that are required to support and execute ... maintenance and repairs as assigned for the equipment and facilities within Sterile and Packaging Operations + Conducts cleaning requirements as assigned in the… more
- Catalent Pharma Solutions (Harmans, MD)
- …and people development. + Highly experienced in Bio pharmaceutical manufacturing and/or aseptic processing working in a GMP environment. + Advanced experience ... Sterility Assurance,** will be responsible for quality assurance oversight of Aseptic Processing Program, Environmental Monitoring and Microbial Control Policies for… more
- Novo Nordisk (Bloomington, IN)
- …what matters. Primary - Drug Product Primary Manufacturing produces sterile pharmaceuticals. The department includes equipment preparation, product formulation, ... material staging, and aseptic filling. Product in this area is filled into...area is filled into vials, syringes, or cartridges inside sterile isolator barriers. The sterile barrier isolator… more
- ThermoFisher Scientific (Greenville, NC)
- …facility). + Experience in a pharmaceutical quality function, preferably in a sterile manufacturing site. + Detailed knowledge of aseptic processing, and ... (Days) **Environmental Conditions** Adherence to all Good Manufacturing Practices ( GMP ) Safety Standards, Office **Job Description** **GROUP/DIVISION SUMMARY** The… more
- Bristol Myers Squibb (Indianapolis, IN)
- …complaints, deviations, investigations, and CAPA management. + Experience working in aseptic / sterile environments and/or in quality control operations focused on ... The Operations Quality Assurance team is responsible for Quality collaboration and GMP /GDP oversight of operations at CDMOs and at Internal site operations,… more
- Novo Nordisk (Bloomington, IN)
- …what matters. Primary - Drug Product Primary Manufacturing produces sterile pharmaceuticals. The department includes equipment preparation, product formulation, ... material staging, and aseptic filling. Product in this area is filled into...area is filled into vials, syringes, or cartridges inside sterile isolator barriers. The sterile barrier isolator… more
- Unither Pharmaceuticals (Rochester, NY)
- …With 30 years of technological expertise, we position ourselves as a world leader in sterile single dose with 10 sites on 4 continents and more than 2000 employees. ... manufacturing and packaging operations using suitable instrumentation according to cGMP 's. Supports laboratory to ensure laboratory procedures, equipment, supplies,… more
- Catalent Pharma Solutions (Harmans, MD)
- …technology; + Familiarity with cGMPs, regulatory filings, and compliance issues for sterile injectable products manufactured by aseptic processing; + Knowledge ... **Principal Engineer, Equipment Aseptic Filling** **Position Summary:** Catalent, Inc. is a...of quality and service. Catalent provides process development and GMP manufacturing services for Phase I/II clinical trials to… more
- Curia (Albuquerque, NM)
- …conversational noise in the background. The pharmaceutical manufacturing environment is sterile . Therefore, aseptic gowning is required. Personal protective ... equipment, processes, utilities, systems, and components in alignment with cGMP regulations, internal procedures, and applicable regulatory expectations. This… more
