DIRECT BIOLOGICS jobs in PENNSYLVANIA, United Kingdom

Job Description The Biologics Technical product leader role is responsible for technical leadership and oversight... for all biologics molecules end to end. This includes both pipeline and in line products. For pipeline, this includes development...

of CMC regulatory requirements for biologics and direct experience with compiling CMC sections for IND and BLA. Previous...The Director/Sr Director, Biologics Process Development will provide strong scientific direction, technical...

Johnson & Johnson Innovative Medicine is currently seeking a Senior Scientist, In Silico Biologics Optimization... will specifically interact with several functional groups across the Biologics Discovery organization to support the discovery...

registration. This position comes with 4 direct reports (Dir, Sr Manager, Manager & Associate III). The Sr Director, Regulatory... of pharmaceutical industry experience. ⦁ Minimum 6 years of Regulatory Affairs experience with biologics and devices ⦁ Managerial...

& Responsibilities Serves as the business owner with direct responsibility for growing the revenues of CGT and Biologics bioanalysis... molecules, large molecules, biologics, medical device, and cell and gene therapy products. The company's US Lab Services and CGT...

is required. Direct experience leading Notified Body/FDA audits is required. Strong knowledge of FDA and EU regulatory compliance... experience is preferred. Experience in pharmaceuticals or Biologics is preferred. Knowledge, Skills and Abilities...

the pharmaceutical/biologics industry. Communicate significant changes in FDA perspective to relevant stakeholders..., compliant promotional regulatory review Required Experience and Skills: Minimum of five years of pharmaceutical/biologics...

about. Job Summary Under direct supervision, responsible for performing basic daily laboratory and clean room tasks as they relate.... About Biologics Testing Solutions With more than 50 years of experience and proven regulatory expertise, the Charles River Biologics...

for biologics and direct experience with compiling CMC sections for IND and BLA. Previous active participation in writing... timely development, transfer and implementation of analytical methods as well as management of all biologics release testing...

is required. Direct experience leading Notified Body/FDA audits is required. Strong knowledge of FDA and EU regulatory compliance... experience is preferred. Experience in pharmaceuticals or Biologics is preferred. Knowledge, Skills and Abilities...

. You will also serve as a representative and subject matter expert on project teams for Teva Biologics programs liaising with internal... study timelines Preferred Experiences: Previous successful experience with managing direct reports is highly desired...

to characterize clinical pharmacokinetics and pharmacodynamics of new chemical entities and biologics, inform dose selection and go/no... a comprehensive understanding of global regulatory expectations for small molecules and biologics, authoring regulatory documents...

and oncology. We actively explore new options for patients including novel compounds, small molecules and biologics, and through... collaborations, alliances, or other relationships through influencing without direct authority, creating effective relationships...

about. Job Summary Under direct supervision, responsible for performing daily laboratory tasks as they relate to Analytical testing..., and location. About Biologics Testing Solutions With more than 50 years of experience and proven regulatory expertise, the...

about. Job Summary Under direct supervision, responsible for performing basic daily laboratory tasks as they relate to the operations... tests. Perform indirect and direct immunofluorescent slide staining. Prepare stock blood solutions...

· Understanding of pFMEA analysis and process characterization is required, with direct experience in late-stage process development... advantageous. · Deep understanding of biologics analytical approaches, strategies and best practices as applied to the...

methods is required. Direct experience with validation requirements supporting sterility assurance of Bio/Pharma/ATMP... products. Strong knowledge of EU and US cGMPs and applicability to manufacturing operations in a biologics environment...