. You’ll work side-by-side with internal partners across development, clinical, commercial, and general and administrative...-world data (EMR, claims), manufacturing or supply chain data, or life sciences-related research data Knowledge of the...
and deliver robust commercial API crystallization processes. Process development may be directed to either batch or continuous... will also be required. Work starts at candidate selection and continues to commercial launch. We strongly believe that innovation in process...
benefit, manufacturing, regulatory strategy, clinical development path, intellectual property and commercial potential o Co...
, and sediments with moderate to complex technical/regulatory issues with manufacturing, power, chemical, oil & gas, and technology... and remediation efforts in both commercial/industrial spaces and residential locations. Review and interpret environmental data...
Responsibilities Execute quality oversight of external manufacturing of both clinical and commercial drug product through... support to all GMP aspects of drug product (DP) manufacturing, CMC and alliance management. This role will work cooperatively...
responsibilities as a Manager Quality Assurance Operations (Contractor): Execute quality oversight of external manufacturing... of both clinical and commercial drug product through lot disposition Provide QA review and approval of internal and external...
, ensuring alignment with organisational goals Partner with R&D, Commercial, Manufacturing, and Operations teams to drive...
with other functional areas in Biogen (Distribution & Logistics, Manufacturing sites, Quality, R&D, etc.) to ensure that international... shipments of non-commercial products are done in a compliant and efficient way. You will collaborate closely with Biogen's SC...
and approval of commercial process validation related documentation including validation plans, manufacturing stage specific... Operations to support the development and optimization of Akebia’s clinical and commercial programs. The incumbent...
and turf, and mission critical solutions. ABM serves a wide range of industries - from commercial office buildings... to universities, airports, hospitals, data centers, manufacturing plants and distribution centers, entertainment venues...
Job titleBusiness Development Specialist Reports toSVP Sales, Commercial Staffing US Job purposeThis... Commercial Staffing (CS) division of Staffing 360 Solutions. It may be combined with other job descriptions as needed based...
within Commercial Manufacturing & Supply Chain (CMSC) department. S/He/They will provide expertise in assay development and validation... and E2E analytical supports to the commercial manufacturing and critical component release for the Cell and Gene therapy (CGT...
best practices, and that sufficient technical and commercial due diligence (whether internal or external) exists to support... to decommissioning). Provide input on appropriate bid levels / commercial strategies and commercial agreements relative to projects...
or cross-selling additional services such as formulation development, analytical testing, and commercial manufacturing... development, manufacturing processes, and regulatory requirements in the pharmaceutical sector. Proven track record of managing...
, Laboratories, Advanced Manufacturing Facilities, Healthcare, Utility Plant and Campus Distribution and Corporate/Commercial. The... university; PE License is a MUST 10+ years of engineering experience in the commercial building design and construction...
and approval of commercial process validation related documentation including validation plans, manufacturing stage specific... Operations to support the development and optimization of Akebia’s clinical and commercial programs. The incumbent...
and finished product across the product lifecycle for both clinical and commercial products. Maintain shipment tracking... stakeholders of status, issues, problems, and propose solutions. Generate purchase orders for manufacturing related activities...
with a broad range of business clients, including commercial, medical, clinical, R&D, technical operations and manufacturing..., clinical trials, manufacturing or commercial and medical matters, as determined in consultation with other members of the Legal...
and tracking of clinical and commercial Quality/CMC submissions including authoring support, adjudicating and addressing the review... and regulations (eg, FDA, EMA and ICH), and Good Manufacturing Practices (GMP). Possess excellent problem-solving abilities...
and finished product across the product lifecycle for both clinical and commercial products. Maintain shipment tracking... stakeholders of status, issues, problems, and propose solutions. Generate purchase orders for manufacturing related activities...