. Cross-Functional Collaboration: Work closely with various functions within Foundry and across PRD/CMC to achieve project... goals and ensure product quality. Investigations and CAPA Support: Lead or assist in process-related investigations, assess...
to find a Senior Director of Regulatory Affairs to lead global regulatory strategy across their clinical development pipeline... strategy, and global regulatory interactions. What you'll own: Lead regulatory strategy for oncology clinical programs...
, and aligned with program CMC strategies. It is highly cross‑functional, partnering with Upstream, Analytical, Formulation, Quality... systems. Technology Transfer & Scale‑Up Lead tech transfer of downstream processes from development to pilot/GMP sites...
technology. Job Description You will: Lead and conduct fundamental and applied research to advance processes... and technologies for ceramic matrix composites (CMCs) relevant to GE Aerospace and external funding agencies. Develop innovative CMC...
. Verify documentation meets CMC/Investor/Agency Standards prior to submission to our operations partners. Adhere to CBI Code... loans in a pre-funded status Manage and deliver best in class client care to an active lead pipeline of up to 150 clients...
it's what's inside that counts There's more to CMC than our products and the buildings, structures, and roads... they go into. At CMC, it's the people inside our recycling centers, fabrication plants, manufacturing facilities, steel mills...
will lead and advance end-to-end drug substance development from early programs through commercial manufacturing. This role owns... manufacturing partners. The Senior Director will define long-term drug substance strategy, support CMC development and commercial...
and respectful fashion with both patients and teammates with every encounter. Representing CMC with the highest level of customer... and teammates as needed. Intentional rounding on patients every hour to ensure their needs are met. Perform 12 lead EKG...
up. Are you ready to go beyond? What You Will Do Pratt & Whitney is seeking a highly motivated individual to lead... is on site at the Ceramic Matrix Composites (CMC) Center of Excellence. CMCs are an enabling material that increases the...
. Serve as a key member of the CMC/Technical Operations team, contributing to organizational process and quality culture. Lead... and regulatory submissions. You'll also: Build and lead multidisciplinary Analytical Development and QC teams. Oversee analytical...
and unleash innovation. This model allows science and small teams of experts to lead the way. We build bridges to groundbreaking..., recruitment needs, geographic considerations, and manufacturing schedules. Act as CMC/Supply Chain SME for any potential audits...
administration on a Q12W+ schedule. This lead candidate offers an accelerated clinical path toward establishing a new disease...-modifying standard of care in IgA Nephropathy (IgAN). Beyond our lead asset, our pipeline includes two additional programs...
). In this role, they will design and lead process characterization and optimization studies resulting in the development of new... programs, focused on CMC development. You will be responsible for: Leverage own experience in cell therapy process...
. Your skills could be critical in helping our teams accelerate progress. The Commercial Process Development team, part of the CMC..., pilot plant experts and project managers within the CMC Synthetics organization Communicate scientific results in a clear...
candidate will lead in the development of conjugation chemistry as well as downstream unit operations culminating in drug... substance and may have supervisory responsibilities. The candidate will serve as the chemistry representative on the CMC team...
-year-old plus a legacy of sophisticated expertise in dosage forms, CMC, large scale manufacturing, and drug discovery... studies in support of vendor qualifications. Lead drafting of product specifications and analytical procedures. Lead...
with the backing of a 90-year-old plus a legacy of sophisticated expertise in dosage forms, CMC, large scale manufacturing... Conduct routine and non-routine analyses of raw materials, in-process materials, stability and finished drug products Lead...
it's what's inside that counts There's more to CMC than our products and the buildings, structures, and roads... they go into. At CMC, it's the people inside our recycling centers, fabrication plants, manufacturing facilities, steel mills...
aligned with discovery and development goals. Serve as the DMPK program lead, overseeing study design, execution, data..., pharmacology, CMC, and clinical groups, to support data-driven decision-making. Manage bioanalytical and DMPK studies conducted...
to transform treatment paradigms and provide unprecedented benefits to patients. The Company's lead product candidate 4D-150..., which substantially reduces the treatment burden associated with current bolus injections. The Company's lead indication for 4D-150 is wet...