therapy cGMP’s and associated CMC regulatory considerations Aseptic processing Experience successfully leading event... and commercial Drug Product disposition. This position reports to Manager GMP Quality - Cell & Gene. REQUIRED KNOWLEDGE, SKILLS...
specific knowledge and expertise to cross-functional project teams (including clinical, CMC and regulatory functions... interactions are expected with collaboration between pharmacology, toxicology, clinical and CMC. The successful candidate...
with cross-functional teams, including Manufacturing, Quality Assurance, Regulatory CMC, and Analytical Development, to ensure... process in accordance with regulatory standard. This role reports to the Director of Quality Control in Cell and Genetic...
departments May draft process descriptions for the CMC section of regulatory documents for early development projects A track... and technical leadership Familiar with early and late phase pharmaceutical development and regulatory expectations Work with Pharm...
to evaluate investment opportunities, and manage business and regulatory risks to ensure company’s investments align.... Collaborate with R&D Finance, CMC/Manufacturing Finance and Program Management teams to maintain accurate and up-to-date R...
for supporting global launches of new products and driving efficiencies throughout the product lifecycle Supports Regulatory on CMC... manufacturing, regulatory, device manufacturing, pharmaceutical sciences, clinical/commercial supply chain, logistics...
with proficient knowledge of the following in a pharmaceutical setting: Cell and gene therapy cGMP’s and associated CMC regulatory... Drug Product disposition. This position reports to Manager GMP Quality - Cell & Gene. Ideal candidate...
from discovery through development to address patient needs. Purpose Of The Position Within regulatory affairs and in cross... and, in partnership with Labeling Operation Manager, global labeling implementation plan Support US affiliate in USPI creation...
development. Scientific Contribution: Collaborate with other R&D functions to address analytical and broader CMC drug development... challenges. Compliance: Ensure adherence to cGMPs (current Good Manufacturing Practices) and Regulatory guidelines. Laboratory...
, and CMC regulatory considerations in a commercial setting. Familiarity with 2-tiered biologics reference standard... responsibilities include executing analytical strategy per regulatory guidelines, providing strategic oversight of drug substance...
to ensure project deliverables supporting regulatory milestones are met and clinical and commercial supply to our patients... direction for late-stage development activities, leading to process performance qualification, associated CMC requirements...
-functional matrix. The Analytical Development Senior Principal Research Scientist will collaborate closely with associate CMC... from exploratory development through various clinical stages to regulatory filing. Key Duties And Responsibilities Lead and serve...
include executing analytical strategy per regulatory guidelines, providing strategic oversight of drug substance and drug.... Additionally, the Associate Director will be accountable for authoring regulatory filings, defining strategies for follow-up...
’s and associated CMC regulatory considerations Aseptic processing Experience successfully leading event investigations, Root Cause... Drug Product disposition. This position reports to Manager GMP Quality - Cell & Gene. Ideal candidate...
process parameters, and contribute to CMC sections of regulatory filings Author, review, and refine technical reports...Job Description General Summary: Vertex is seeking a talented individual to join our CMC Process Development team...
to simultaneously driving regulatory approval as well as launch and global patient access Ability to partner with all functions... to the GPL on the sub-team objectives. Accountable with the responsible Global Program Manager for activities operating...
with proficient knowledge of the following in a pharmaceutical setting: Cell and gene therapy cGMP’s and associated CMC regulatory... Drug Product disposition. This position reports to Manager GMP Quality - Cell & Gene. Ideal candidate...
as a Senior Scientist/Manager. The Process Development Engineering Senior Scientist/Manager will be responsible for leading... Applies QbD principals to process characterization, establishes process parameters, and contributes to CMC sections...