- Kelly Services (St. Louis, MO)
- …chemical technology transfer to a contract manufacturing site. More about the Role: Lead API Scale-Up in a Cutting-Edge GMP Facility! 3-7 years' experience ... with engineering to ensure fit-for-purpose systems. Validation & Compliance: Lead /author process validation docs, batch records, change controls; investigate… more
- SBM Management (Tustin, CA)
- …will be responsible for coordinating and managing project tasks in the GMP Program to ensure project delivery within allotted budget and timelines. Responsibilities: ... each essential duty satisfactorily. Other duties may be assigned. + Assist GMP managers and supervisors in day-to-day coordination, scheduling and management of… more
- Amgen (Thousand Oaks, CA)
- …Analytical project leadership experience + Strong leadership skills and ability independently lead + Solid understanding of GMP requirements and familiarity with ... in partnership with their manager. **Key Responsibilities Include:** + Lead analytical method lifecycle management activities including method remediation,… more
- ADM (Kennesaw, GA)
- …requirements to personnel working in the lab and ensure that they are completed per GMP , GLP and ISO 17025 standards + Lead and facilitate initial and periodic ... feedback on standard operating procedures, forms, and documents. **Management** + Lead chemistry department with effective mentoring, directing and coordination of… more
- Amgen (New Albany, OH)
- …this role, you will support the commissioning, qualification, and validation (CQV) of GMP equipment and processes that enable Final Drug Product (FDP) operations at ... device assembly and packaging equipment. + Support trouble shooting and lead investigations for technical issues impacting equipment performance or reliability. +… more
- Lilly (Lebanon, IN)
- …review and approval of all documentation issued to support the validation/qualification of non- GMP and GMP systems, as appropriate. + Provide input and execute ... working in collaboration with Computer Systems Quality Assurance on GMP related systems. Also responsible for privacy initiatives to...+ Ability to take initiative, to be assertive, to lead by example and to build high-quality relationships. +… more
- Fujifilm (Holly Springs, NC)
- …strong operational excellence skills, we have an exceptional opportunity for you to lead and grow in a world-class Quality organization as the Director, QA Drug ... and tested in strict compliance with Good Manufacturing Practices ( GMP ) regulations. You will maintain quality systems that align...and process together with monitoring of Quality metrics for GMP Operations + Works with internal teams and clients… more
- Astellas Pharma (Sanford, NC)
- …ongoing commissioning and validation activities as the site works towards GMP production readiness and will provide overall manufacturing operations support that ... the role will be responsible for executing a combination of engineering and GMP clinical batches with supporting staff. This role, as part of the Manufacturing… more
- Lilly (Lebanon, IN)
- …facility, and the culture to enable a successful startup into GMP manufacturing operations. **Position Description:** The **Associate Director Process Engineering - ... organization, develop and implement the necessary business processes required to support GMP operations, and build the site culture. This will require significant… more
- Amgen (Holly Springs, NC)
- …Manager for the Single Use Systems and Cleaning Validation Team in our GMP Drug Substance Manufacturing facility. This position is within Amgen North Carolina (ANC) ... environment and an important supply facility for Amgen's pipeline products. The GMP FlexBatch plant manufactures drug substance for clinical trials and commercial… more