Organization located in US Large Molecule Drug Substance Site located in Wilson, North Carolina. This role will support a new site... stays with vendors, sister companies, partners). While this role will ultimately support the site operations located...
biologics drug substance manufacturing, site Product Development, and laboratory operations. Member of the Devens Site... and will be accountable for the Manufacturing Digital Operations and support operations of the site – to include Commercial and Clinical...
. Participates in the development of global Product Quality Assurance strategy to support pharmaceuticals biologics device... delivery of product while assuring compliance to local divisional and corporate policies and external agency regulations...
, and external manufacturing partners to drive project execution, ensure alignment with key milestones, and support... responsible for executing manufacturing and supply chain strategies for late-stage development and commercialization of biologics...
and individuals. Strong quality assurance/control, manufacturing, laboratory, technical support, regulatory, and/or validation.... Develops Global Product Quality Assurance strategy and implements agreed strategy to support the development of NPI projects...
for critical technical scientific evaluation of CMC drug substance, drug product, and device development information during due... or licensing opportunities, across various drug/combination product asset types and therapeutic areas. Partner with Clinical...
integration and support of device regulations, drug regulations and as appropriate, biologics regulations. Responsible... and individuals. Key Stakeholders External Manufacturing Business Relationships, Operations, Third Party Manufacturers Business...
constraints. Provides technical support and leads team of external validation engineers through commissioning, qualification... for leading and executing CQV activities for a large-scale biologics manufacturing facility in compliance with regulatory...
constraints. Provides technical support and leads team of external validation engineers through commissioning, qualification... for leading and executing CQV activities for a large-scale biologics manufacturing facility in compliance with regulatory...
: Provide scientific expertise and technical guidance on parenteral drug product manufacturing processes, including formulation... and improve people’s lives. This Director, Manufacturing Science & Technology (MS&T) – Drug Product (Parenteral) opening...
to clinical and commercial biomanufacturing and drug product fill/finish and packaging. The Bloomington campus is a recognized... Supervises the daily activities of business, technical support or production team Typically manages 5-30+ employees Sets...
Nordisk and help us make what matters. Primary - Drug Product Primary Manufacturing produces sterile pharmaceuticals. The... barrier between the manufacturing equipment and the personnel controlling the machine. The Drug Product Primary Manufacturing...
machine. The Drug Product Primary Manufacturing area is a cleanroom environment. Personnel working in this area... - The Drug Substance - Operations department is responsible for the execution of clinical and commercial manufacturing...
, and manufacturing System Processes. This new global support function will contribute to the modernization and transformation of the... collaboration with M&S functions (incl. GBUs, Strategy, Launches & OpEx Team, Supply Chain, Manufacturing, Finance, External...
team provides support for cGMP Manufacturing operations, ensuring compliance with all applicable internal SOPs as well... and formulation to clinical and commercial biomanufacturing and drug product fill/finish and packaging. The Bloomington campus...
of processes throughout a product lifecycle. The Manufacturing Process Compliance team provides support for cGMP Manufacturing... Project Delivery: The supervisor will ensure batch manufacturing readiness, support operations for rapid response and Person...
involves close cooperation and cross-functional interaction with Technical Development Teams, Regulatory, MSAT, Operations, CMO... and/or packaging solutions based on patient, product, regulatory, business or technical requirements. Ensure compliance...
Nordisk and help us make what matters. Primary - Drug Product Primary Manufacturing produces sterile pharmaceuticals. The... barrier between the manufacturing equipment and the personnel controlling the machine. The Drug Product Primary Manufacturing...
machine. The Drug Product Primary Manufacturing area is a cleanroom environment. Personnel working in this area... - The Drug Substance - Operations department is responsible for the execution of clinical and commercial manufacturing...
from technical development, through manufacturing operations and culminating in the successful preparation of regulatory submissions... results to the larger Insmed research and technical operations groups, and external scientific community, as needed. Present...