- BeOne Medicines (Pennington, NJ)
- …facility and then shift focus to hands-on execution and support of cGMP manufacturing operations. **Facility Start-Up** : Focused on related activities required to ... execution + Acceptance testing and equipment/automation debugging + Technical training **Hands-On cGMP Operations** : Focused on execution of cGMP manufacturing… more
- Cardinal Health (East Rutherford, NJ)
- …day. Work hours may be subject to change. **Accountabilities** + Handles CGMP documentation review related to product release, facilities and equipment, material ... the site manufactures products to meet the requirements of 21 CFR 212 ( CGMP ) + Handles and ensures quality of documentation (control, retention, and archival) to… more
- Bristol Myers Squibb (Summit, NJ)
- …product Value Stream outputs according to Current Good Manufacturing Practices ( cGMP 's) following the current, approved Standard Operating Procedures (SOPs) and Work ... and local laws. + Drive compliance with current Good Manufacturing Procedures ( cGMP ), USP, EU and other global regulatory requirements. + Drive completion, adherence… more
- Merck (Rahway, NJ)
- …Center in Rahway, New Jersey, features a cutting-edge sterile drug product cGMP clinical supply manufacturing facility, known as FLEx Sterile. The FLEx Sterile ... model, define core processes, and set performance standards that meet cGMP , aseptic processing, and safety requirements. In parallel, the Associate Director,… more
- Hovione (East Windsor, NJ)
- …with the necessary automation technologies, capacity, reliability and in compliance with cGMP and project specifications. - In the early designing phases, guarantee ... that cGMP and HSE requirements and adequate Engineering solutions are...review phase of the Engineering projects to ensure that cGMP and adequate technical solutions are dully incorporated -… more
- Bristol Myers Squibb (Summit, NJ)
- …completely understand, follow, interpret, and apply Global Regulatory and cGMP requirements. + Experience supporting health authority inspections. Sr. ... accurately and completely understand, follow, interpret, apply Global Regulatory and cGMP requirements. + Ability to support health authority inspections. +… more
- Teva Pharmaceuticals (Edison, NJ)
- …coordinate setups and changeovers, and maintain smooth operations while adhering to cGMP , Safety and company procedures. + Shift Time: Sunday - Thursday : ... perform room, line, and equipment cleaning. * Comply with company policies, SOPs, cGMP , DEA, and OSHA requirements. * Assist in identifying health, safety, and… more
- Kelly Services (Princeton, NJ)
- …drug product (DP), and stability samples. Maintain compliance with FDA, EU and cGMP requirements. + Oversee the development and implementation of SOPs, test methods, ... Pharmaceutical + Minimum 5-7 years of relevant industry experience in a cGMP -regulated pharmaceutical or biotechnology environment. + At least 2 years of leadership… more
- J&J Family of Companies (Raritan, NJ)
- …developing and retaining talent in the organization + Comprehensive regulatory cGMP and technical knowledge to develop sterility assurance strategies necessary to ... programs to regulatory reviewers + Experience with implementing and overseeing cGMP operations in a commercial manufacturing facility + Demonstrated experience… more
- Bristol Myers Squibb (Summit, NJ)
- …(DP) Packout to patients) within CAR T clinical and commercial operations in a cGMP multi-cleanroom suite. This position plays a critical role in the CAR T ... product Value Stream outputs according to Current Good Manufacturing Practices ( cGMP 's) following the current, approved Standard Operating Procedures (SOPs) and Work… more
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