Sort by
Refine Your Search
-
Listed
-
Employer
-
Field
-
The R&D Manufacturing Process Development team is looking for a Senior Biologics Development Manager. The ideal candidate has a passion for bringing innovative products to the market and understands
-
The Supervisor is accountable and responsible for leading assigned production staff to achieve targets and deliver and improve process or product consistency, quality/compliance, cost standards and customer
-
on deliverables throughout the process Provide input for the design of the Statistical Analysis Plan (SAP) and the clinical data output Responsible for review of patient level data across a study and for
-
Sciences group by way of process improvement. Develop expertise navigating Pfizer compliance systems, registries (e.g. GDMS, pTMF, Clinical Trial Registries, etc.) and other study systems related
-
taking action. What You Will Achieve You will work as part of a team to perform scientific, operational and process engineering tasks as they relate to technology transfer, scale-up operations, capital
-
Operating Unit. Provide support as needed to Quality Operations, Production and Engineering to assess product and process aseptic issues. Participate in internal and external quality assurance assessments and
-
chemical, biological, and manufacturing quality groups, in addition to manufacturing leadership and process personnel and proactively partners with site and global Supply Chain, Operations, and Quality
-
May manage the study start up process in countries assigned (where SUPM not assigned) and/or oversee pCRO responsible for these activities as applicable Through the Site Care Partner/Country Trial
-
for applicable countries Demonstrated knowledge of site intelligence at country/cluster level in support of site recommendation Demonstrated knowledge of clinical trial methodology and the drug development process
-
of the drug development process and regional regulatory requirements Experience in the preparation/submission of regulatory documentation to support regulatory submissions Excellent oral and written