development and manufacturing of biologics drug products for our growing pipeline. The Vertex Process Development team...-filled syringes and other novel primary packaging. Oversee drug product technology transfer, process development and GMP...
and quality oversight for contract testing laboratories (CTLs) supporting Vertex’s biologics and combination product portfolio... product programs. Collaborate with CMC, Analytical Development, QC, MS&T, Device Engineering, QA Device, and Regulatory...
therapeutic programs and with expertise in small molecule and/or biologics drug development 10 years of direct line management.... The Director Inflammatory Drug Discovery Will be responsible for developing industry-leading therapeutics for patients...
erythematosus or rheumatoid arthritis. Understanding of the entire drug development process, including clinical and non-clinical.... Early Clinical Development in R&I is where science meets clinical drug development with a focus upon delivering innovative...
, optimizing supply chain efficiency,, cost, and long term success across clinical development, commercial launch, and product... A comprehensive understanding of product development, manufacturing and supply management within a matrixed environment...
Director/Senior Director, Regulatory CMC to lead and execute regulatory CMC strategies for our cutting-edge gene therapy... portfolio. This role will be critical in shaping the regulatory path for novel gene therapies from early development through...
Practices (cGMP), drug and biologics development regulations and guidelines including FDA and EMA guidelines for gene therapy... of regulatory strategies with manufacturing and development activities by partnering with Technical Operations, Process Development...
and its activities, the development of regulatory strategy, and contributing the regulatory approval process (including US FDA... as well as biopharma partner projects. Develop and implement regulatory strategy for non-clinical product development...
with potentially first-in-class and best-in-class therapies, including antibody-drug conjugates (ADCs), complex biologics and small... and access environments to strengthen product development plan(s) and adopt regulatory strategies in a timely manner...
experience. Solid working knowledge of drug development process and regulatory requirements. Knowledge of FDA...By clicking the “Apply” button, I understand that my employment application process with Takeda will commence...
pharmaceutical industry, inclusive of regulatory and/or related experience. Solid working knowledge of drug development process... that impact both the regulatory and access environments to strengthen product development plan(s) and adopt regulatory strategies...
-functional PO&T Asset Team, which includes representatives from process and analytical development, manufacturing, quality... You Are You are an experienced leader with a deep background in CMC drug development, supply chain, or manufacturing. As a member of ADPM...