- Fujifilm (College Station, TX)
- … Director QualityOperations - Shared Services isresponsible for QA oversight of CGMP manufacturing operations and areas at FDBT Shared Services (drug product, ... and on-time delivery. Ensure products are manufactured to meet all CGMP regulatory requirements for phase-appropriate clinical and commercial bulk drug substance… more
- Merck (Austin, TX)
- …and External Manufacturing Operations within a designated region in the Manufacturing Division. As Associate Director of Asset Management & Reliability CoE ... **Job Description** Reporting to the Director , Asset Management & Reliability, in this role...and improvement methods and tools. + Solid understanding of cGMP , Sterile Manufacturing , Formulation & Filling, and… more
- J&J Family of Companies (Austin, TX)
- …this Director of Radioligand Therapy will help establish a manufacturing process for radiopharmaceutical programs that will focus on automation, high throughput, ... Director of Radioligand Therapies, Global MSAT (Advanced Therapies)...Johnson Innovative Medicines is recruiting for the Advanced Therapies Manufacturing Science and Technology (MSAT) organization! We are working… more
- Fujifilm (Austin, TX)
- …in viral gene therapies (VGTs), infectious biological agents, and current good manufacturing practices ( cGMP ) + Experience in hazard/risk assessment within ... **Overview** As the Associate Director of Biosafety, you will serve as the...risk assessment across global sites, ensuring safe laboratory and manufacturing work practices as well as product quality and… more
- Fujifilm (Austin, TX)
- …Irvine Scientific, Inc. adheres to ISO and FDA regulations and operates dual cGMP manufacturing facilities in California, USA, and Tokyo, Japan. The company's ... Corporation, reporting to FUJIFILM Holdings Corporation. We are hiring an Associate Director , Corporate Accounts & Strategic Alliances. The Associate Director ,… more
- Fujifilm (College Station, TX)
- …required). + Work with Quality management to implement quality systems that will enable cGMP manufacturing of pre-clinical to commercial products. + Work as a ... gaps based on business priority and risks. **Reports to** Senior Director , QA Compliance **Work Location** College Station, TX **Primary Responsibilities:** +… more
- Fujifilm (College Station, TX)
- …with mentoring and support from the Head of Program Management and/or Associate Program Director or Program Director , will be responsible for the planning and ... and the Company's vision/mission (strategy and compliance). **Reports to** Program Director , Program Management **Work Location** College Station, TX **Travel** As… more
- Fujifilm (College Station, TX)
- …and revising microbiological Standard Operating Procedures (SOPs) and other current Good Manufacturing Practices ( cGMP ) documentation. + Review of EM and product ... III, Microbiology will be responsible for the QC microbiological aspects of cGMP compliance and testing at the FUJIFILM Diosynth Biotechnologies Texas (FDBT) Quality… more
- Fujifilm (College Station, TX)
- …policies and site SOPs to ensure regulatory compliance. **Reports to** Director , QA Compliance **Work Location** College Station, TX **Primary Responsibilities:** ... 4+ years of supervisory experience. + 4+ years of cGMP experience. + Single Use and Process Validation preferred....work weekends and off-shift hours, as needed to support manufacturing activities. + Must be willing to travel occasionally,… more
- Merck (Austin, TX)
- **Job Description** Reporting to the Director , Asset & Reliability Management CoE, the **Senior Specialist, Asset & Reliability Management CoE** , will be ... Management activities to support Vaccine, Sterile, Pharmaceutical, and External Manufacturing Operations within the Manufacturing Division. The individual… more
- Fujifilm (College Station, TX)
- …relevant databases and liaising with Program Directors. **Reports to** Director , Program Management **Work Location** College Station, TX **Primary ... of the program (contract sign, PD US/DS, AD, Tech Transfer, Clinical-Commercial Manufacturing , QA, QC, Release, Ship Deliverables, Transfer in and Transfer out). +… more
- Fujifilm (College Station, TX)
- …provide daily guidance, work prioritization and support to other departments, such as manufacturing or QC, in absence of or in conjunction with their manager. ... **Reports to** Director /Senior Manager/Supervisor, Quality Assurance **Work Location** College Station, TX...+ All candidates must have a working knowledge of cGMP regulations for the production of drug, biologics or… more