Olema Oncology is dedicated to developing better medicines for breast cancer and beyond. Our lead program, palazestrant... and other presentations . About the Role Associate Director, Regulatory Affairs CMC As the Associate Director, Regulatory Affairs CMC...
and external functions. Build and lead fit-for-purpose cross-functional CMC matrix teams, aligning timelines, deliverables... interactions as the CMC lead contributor. Maintain currency with US, European, Japanese, Chinese, and ICH regulations and industry...
Responsibilities Lead all project initiation and planning efforts. Participate in the implementation and execution... of relevant pharmaceutical or biotech industry experience in discovery chemistry, CMC process development and/or GMP manufacturing...
product. What You’ll Do Lead the CMC Component Design EIS team in the shop, fostering a culture of collaboration, ownership... the LEAP fleet flying reliably ~ Driving continuous improvement in how we design and manufacture CMC components...
is to deliver projects in the pharmaceutical CMC development area for ZS clients. This includes serving as a subject matter expert..., Mechanical Engineering, Chemistry, Biotechnology or similar degree 6-8 years of experience working in a pharmaceutical CMC...
Job Description Summary The Sub-Section Manager for Commercial CMC Nozzle Design leads a high-performing team of design... requires a blend of technical depth in hot-section/CMC design, team leadership, and disciplined program execution aligned...
About This Role: As the Senior Director, Global Regulatory CMC - Drug-Device Combination Products, you will serve... Delivery Solutions team, you will have end-to-end accountability for defining and executing CMC regulatory strategy...
Director/Senior Director, Regulatory CMC to lead and execute regulatory CMC strategies for our cutting-edge gene therapy... submissions. Lead and manage the preparation, authoring, and review of high-quality CMC sections for all regulatory submissions...
Job Description Summary The CMC Raw Material Obeya Leader will support the Value Stream Integration Leader in driving... to work independently as well as collaboratively within a team. This role will focus on leading key initiatives in CMC Raw...
Olema Oncology is dedicated to developing better medicines for breast cancer and beyond. Our lead program, palazestrant... and other presentations . About the Role Associate Director, Regulatory Affairs CMC As the Associate Director, Regulatory Affairs CMC...
Job Description Summary The CMC Product Engineer will lead the strategic management of process improvements, stability..., and growth across Commercial and Military product lines to meet site goals. The CMC Product Engineer will develop and utilize...
(s) In alignment with GRDRA CMC functions, GRDRA region functions and Senior Director or Reg CMC Lead, agree on the regulatory strategy... Currently seeking a Regulatory Affairs (RA) Senior Manager with strong CMC pre and post approval experience to support Chiesi...
are determined to make life better for people around the world. Position Overview: The Manager, CMC Operations is responsible...). This role will lead projects from the start of the technology transfer process through approval of the applicable regulatory...
Senior CMC Data Scientist/Statistician This role can be located in the Denver metro area, or Seattle, WA Salary Range.... The ideal candidate has proven statistical expertise across Analytical Development and Quality, driving critical CMC...
Responsibilities: Lead the preparation, review, and submission of CMC sections of regulatory filings (e.g., INDs... changes. Interpret and communicate regulatory requirements, guidelines, and expectations related to CMC to internal...
Scientist with deep data expertise in the pharmaceutical domain to lead the development and delivery of enterprise-scale data... pharmaceutical sciences with modern data engineering to transform complex CMC, PAT, and analytical data into strategic assets...
of what is possible in order to bring life-changing therapies to patients worldwide. The Director Regulatory Site CMC ensures efficient... CMC requirements relevant to global drug development and post-market support. Who has a proven ability to understand...
to accelerate development in a dynamic environment. Lead creation and execution of comprehensive CMC development plans for new... scientific hypotheses. We believe the asset-centric model can lead to improved success rates for programs with greater speed...
. ESSENTIAL DUTIES/RESPONSIBILITIES: Lead development of high quality, phase appropriate CMC-related submissions to regulatory... with departmental and company growth. Lead internal preparation of CMC strategy in support of any required meetings with Regulatory...
molecule programs. Responsibilities include: Lead Quality Control (QC) activities for clinical and commercial products..., including management of in-process and release testing of GMP products Lead and manage QC staff including hiring, developing...