Senior Associate, Regulatory CMC We are seeking a Senior Associate, Regulatory CMC with deep expertise in biological and cell therapy products and CMC regulatory requirements. This role will directly support strategy, compliance, and submissions for complex manufacturing processes and
Opportunity for Secondment to AskBio Were pleased to share an exciting secondment opportunity at AskBio. This role is available for a time period to be determined by leadership at both Bayer and AskBio. While most assignments
Senior Director, Drug Development Program Leadership Responsible for Drug Development Program Leadership services. Provides leadership and oversight for the successful delivery of complex pharmaceutical and biotechnology development programs across all stages of development. Leads integrated cross-functional teams and serves as
Associate Director / Director, CMC Regulatory Affairs The Associate Director / Director, CMC Regulatory Affairs will lead global CMC regulatory strategy and execution for the companys gene therapy programs from early research through clinical development and commercialization. This role is
California, US residents click here. The job details are as follows: Who We Are We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation. Our public benefit purpose
Director / Senior Director, Regulatory Affairs The company is seeking a Director or Senior Director of Regulatory Affairs with the final title set according to the selected candidates background to help shape and steer the execution
Program Integration Associate II The Program Integration Associate II independently coordinates planning, integration, and execution-readiness activities across process development and CMC programs. The position applies technical and operational knowledge to support facility fit assessments, BOM forecasting, regulatory readiness
Director, Program Management The Director, Program Management, will act as the key interface with stakeholders outside of Operations Transformation organization to ensure cross-functional alignment for all strategic projects resulting in seamless execution and delivery of projects.
Night Auditor CMC Hotels is a Raleigh, North Carolina based company specializing in the development, acquisition, repositioning and management of upscale limited service, extended stay and full service hotels. Our properties lead the market, consistently exceeding operational and
This job is with Biogen, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly. About This Role: The Biologics VTR (Validation,
Small Molecule Drug Substance Leader You will lead small molecule drug substance activities from lab development through clinical and commercial manufacturing readiness. You will work closely with teams in process development, quality, regulatory, manufacturing and supply. We value
Director/Associate Director Regulatory Affairs Contribute to the development and oversee the implementation of global regulatory strategies for assigned programs in alignment and compliance with local and regional requirements and company policies. Ensure effective communication with business partners
SUMMARY This is a drug delivery role inside the Formulation Sciences team. Youd own selection and advancement of the delivery system — prefilled syringe, autoinjector, or on-body — for a self-administered protein biologic. Device and combination
SUMMARY Clinical-stage biotech advancing antibody into Phase 2b Senior scientific leader for analytical strategy — control strategy, comparability, validation, characterization through BLA Direct ownership, no layers; drive the work with CDMOs and external labs About the
Company Description About AbbVie AbbVies mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on