- Alloy Therapeutics (Waltham, MA)
- …a team dedicated to advancing oligonucleotide-based therapeutics from discovery through GMP manufacturing. This leader will oversee process development and scale-up ... and single guide RNAs (sgRNAs) for both research-use-only (RUO) and GMP -compliant applications. The ideal candidate combines deep scientific expertise in… more
- Jabil (Hunt Valley, MD)
- …as well as all aspects of engineering with a special focus on GMP Manufacturing equipment uptime, including the routine reporting of equipment and system status, ... facilities such as solid, soft gel, Aseptic manufacturing, and GMP labels. + Ensure the Pii facilities meets the...identify where the gaps are in the Pii Facilities GMP compliance position and make recommendations to the leadership… more
- Otsuka America Pharmaceutical Inc. (Boise, ID)
- …and downstream biologics manufacturing processes, ensuring compliance with biologics-specific GMP requirements. This role has global responsibility for directing ... improvement. **Job Description** + Responsible for directing quality oversight of GMP contract manufacturers of Otsuka clinical and commercial products. + Develops… more
- Price Chopper (Schenectady, NY)
- …monitoring standards, and ensuring adherence to Good Manufacturing Practices ( GMP ), HACCP, and company policies. **ESSENTIAL DUTIES AND RESPONSIBILITIES** + ... all products are manufactured in compliance with food safety, GMP , HACCP, USDA, FDA, and corporate policies. + Maintain...and training of new teammates in commissary procedures and GMP compliance. + Foster a culture of safety, quality,… more
- Genentech (Oceanside, CA)
- …the support of Product Transfers and Make/Assess/Release in a 24x7 Good Manufacturing Practice ( GMP ) environment. As part of the Site Team and larger Global IT OT ... alerts and logs. + Support virtualization (VMware) and system redundancy for critical GMP applications. **Compliance & Validation** + Ensure systems meet GxP and FDA… more
- PCI Pharma Services (Bedford, NH)
- …heating, ventilation, and air conditioning HVAC, plumbing, etc.) for GMP facilities, utilities equipment, laboratories, warehouse and buildings. **ESSENTIAL DUTIES ... + Operate, maintain, and monitor all equipment utilities systems that supply GMP manufacturing. + Perform preventative, routine, and non-routine maintenance on … more
- Lilly (Durham, NC)
- …QA Floor Support Supervisor. Responsibilities include providing QA oversight to GMP operations in the Parenteral equipment preparation, formulation, filling, and ... presence in assigned parenteral areas to monitor aseptic behaviors, GMP programs and quality systems. + Reviews and approves... programs and quality systems. + Reviews and approves GMP documentation in support of daily operations such as:… more
- PCI Pharma Services (Madison, WI)
- …I - Operations** , where you'll be on the front lines of GMP production-supporting real-time quality oversight, solving problems as they arise, and ensuring that ... floor: observe critical operations, audit procedures, and monitor compliance during GMP manufacturing + Perform in-process reviews of executed batch records and… more
- Astellas Pharma (Westborough, MA)
- …and industry best practices. The Validation Manager will ensure that all critical GMP equipment and systems are validated and maintained in compliance with user ... Global Validation Strategy for the organization, ensuring all steps of the GMP organization remain compliant with Astellas procedures and domestic / international … more
- Lilly (Indianapolis, IN)
- …and implement the necessary systems and business processes required to support GMP operations, and build the site culture. This will require significant ... and resilience as the site grows to a full scale GMP manufacturing through start up. **Responsibilities** Key Objectives/Deliverables: + Technical Leadership… more