DS/DP release within planned timelines. The mRNA CMC Project Lead will be responsible for: Leading quality and process... related activities to ensure the successful launch of mRNA projects. Representing Centivax as Lead on mRNA CMC Project teams...
, and Project Management) to ensure CMC regulatory strategy aligns with overall program objectives and timelines. Regulatory... Compliance & Guidance: Serve as the regulatory lead for CMC-related issues, ensuring compliance with applicable global...
Management. Primary Responsibilities: Lead and chair the LTG-001 Program Team, partnering with the Project Manager and cross...Title: Director/ Sr. Director, Program Lead, LTG-001 Location: Thousand Oaks, CA or San Francisco, CA Company...
solution covers CMC of plasmid and virus for IND filing as well as clinical manufacturing and commercial manufacturing...: recruit, train, mentor and lead impactful team of BDs by cultivating a collaborative and motivated environment. Remove...
but not limited to potential assignments in research, development, clinical, medical affairs or CMC project or business management... development project management (e.g. research, clinical, CMC, commercial, medical affairs), including clinical project management...
from other functions on all aspects of CMC project deliverables. The scope of supported projects includes those in both early- and late... Culture and Bioprocess Operations (CCBO) group. Job Responsibilities: Lead a team of cell culture engineers / scientists...
individual will lead a multidisciplinary team of analytical, biological, and quality control scientists in support of the CMC... of CMC project deliverables. Key collaborators and interfaces include Quality, Genentech Research, Regulatory...
of processes in preparation for transfer to manufacturing Lead and support various elements of early-stage CMC development.... We are seeking a Senior Scientist I to lead our downstream process development and technology transfer efforts for our diverse...
Director, GMP QA, reporting to the Director of GMP Quality Assurance. The role will work closely with the CMC Team to ensure... will be responsible to provide the quality operational support for the CMC teams and support the quality organization in building the...
providers in accordance with health authority and ICH requirements. In addition to being a key member of our project teams, she... Affairs representative on assigned project teams and assure the progress of projects by providing direction, solutions...
- our goal is to fundamentally change the outcomes for these patients. Alumis is hiring a VP, Quality to lead the GMPQA... Operations and GLP functions within Alumis. This role will work closely with the CMC and Preclinical leadership and support the...
representative for project(s). Executes strategy, lead teams and various data analyses and interpretation by providing necessary... to clinical, CMC and regulatory teams. Authors scientific publications and present at national and international conferences...
or global study lead (e.g., Medical Monitor, Regulatory Affairs, Safety, CMC, Supply Chain, CQA, CRO, vendors and Investigators.... May lead cross functional study management team or oversee clinical trial execution in one or more regions within a global...
As local regulatory lead, represent Regulatory Affairs (RA) in assigned project meetings and provide regulatory guidance... in international markets, with a focus on the US, EU, Australia, and China. This role will be the local regulatory lead and internal...