- Bristol Myers Squibb (New Brunswick, NJ)
- …**Key Responsibilities** Activities you will be involved in during your placement as EXM Quality Bio - Sterile Intern include: + Support the Bristol Myers ... the BioPharma industry. The position will provide support to External Quality representatives managing relationships with Contract...Performance metrics of the various business units of EXM Bio - Sterile Quality for Quality… more
- Merck (Rahway, NJ)
- …+ Working knowledge of current Good Manufacturing Practices (cGMPs) for manufacturing of sterile dosage forms and current ICH Quality norms, as applied in ... & Supply Division is committed to be the most trusted supplier of bio -pharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers,… more
- Merck (Rahway, NJ)
- …to pilot and/or manufacturing scales. + Working knowledge of cGMPs for manufacturing of sterile dosage forms and current ICH Quality norms as applied in ... + Working knowledge of regulatory requirements for commercialization and registration of sterile drug products, including application of Quality by Design… more
- Actalent (Parsippany Troy Hills, NJ)
- …closely with the R&D, Technical Operations, and clinical development teams, along with external consultants. The Head of Regulatory Affairs will be a key member of ... and inspire top talent within the Regulatory Affairs organization. + Form an external advisory board of regulatory counsels as required and build relationships with… more
- Kedrion Biopharma (Fort Lee, NJ)
- …Product Returns process. The position also involves providing support for quality tasks related to KBI's contract manufacturing organizations (CMOs) and contributing ... to KBI's Quality Management system initiatives. **Product Distribution and Product Returns**...activities and tasks, as assigned + Manage and support internal/ external audits, and inspections as assigned. + Manage internal… more
- Lilly (Branchburg, NJ)
- …Finally, this role provides ad-hoc technical support to Lilly PR&D, external contract manufacturing, and non- sterile drug substance (API) manufacturing. ... technical support to Lilly organizations outside of the PPN including PR&D, external contract manufacturing, and non- sterile drug substance (API) manufacturing.… more
- Merck (Rahway, NJ)
- …models to support the development and commercialization of biologics, vaccines, sterile liquids, and other large-molecules modalities. In this role, you will ... outcomes: reduced costs, fewer experiments and batches, faster timelines, improved quality and process robustness. + Demonstrate creativity in solving complex,… more
- J&J Family of Companies (Raritan, NJ)
- …Perform tasks on time in a manner consistent with the safety policies, quality systems and cGMP requirements. * Execute production activities common to cell culture ... and/or microfiltration/ultrafiltration systems, purification, automated filler (ie FP50) and sterile filling using appropriate techniques. * Perform tasks related to… more