Cardinal Health, headquartered in Dublin, Ohio, seeks a Scientist I - CMC to support regulatory activities for pre- and post-approval changes and lifecycle management. You will coordinate with cross-functional teams to deliver high-quality regulatory submission content while
Pulmovant is a Roivant-backed clinical-stage biotechnology company developing innovative therapies for patients suffering from pulmonary diseases. Pulmovant’s first program, mosliciguat is designed to provide an effective, once-daily, inhaled treatment option for patients with pulmonary hypertension (PH).
Sabin Vaccine Institute, Inc. in the United States is seeking a Senior Manager, CMC Technical Operations to drive end-to-end CMC activities from development through regulatory readiness. You will partner with the CMC Product Champion and external partners to align
BridgeBio Inc. is seeking an Associate Director/Director of Pharmaceutical Development to lead CMC strategies for regenerative medicines, working remotely in the U.S. with travel expectations. This role focuses on formulation development, clinical supply, and regulatory documentation to
Location: This position may be performed remotely but requires flexibility and a willingness to travel as needed. Position Summary The Associate Director, Regulatory CMC willbe responsible forthe planning, preparation, and execution of Chemistry, Manufacturing, and Controls (CMC) regulatory
Praxis Precision Medicines, Inc. is seeking an Associate Director, Regulatory CMC to lead planning, preparation, and execution of regulatory activities for small molecule and ASO programs. You will coordinate with cross-functional teams and external vendors to support
Cardinal Health is seeking a Scientist III CMC to lead regulatory strategy and execution for pre- and post-approval changes and lifecycle management across client Rx and non-Rx programs. You will work as a senior consultant, authoring and
Position Summary: Linguists are key players at TransPerfect. Your particular language skill and subject matter expertise will allow you to create and finalize the end product before it goes to the client. Under the guidance of
Position Summary: Linguists are key players at TransPerfect. Your particular language skill and subject matter expertise will allow you to create and finalize the end product before it goes to the client. Under the guidance of
Enliven Therapeutics, a clinical-stage biopharmaceutical company, seeks a Vice President, Supply Chain to own global supply strategy across clinical and late-stage programs. You will ensure uninterrupted supply of investigational products and coordinate with CMC, Clinical Operations, Quality,
Location: This position may be performed remotely, but requires the flexibility and willingness to travel as needed. Opportunity As Director of Process Chemistry, you will take the lead on drug substance activities for one or more
BioAge Labs is seeking a Director, Clinical Supply Chain (or Senior Director) for a fully remote role in the continental US. You will lead end-to-end clinical supply planning, forecasting, and distribution across global trials, partnering with
Cogent Biosciences is seeking an Associate Director, Analytical Development for remote work in the United States. You will lead analytical activities across Cogent’s development portfolio, partnering with Regulatory CMC, Quality, and external CDMOs to ensure analytical data,
Loyal is seeking a Principal Analytical QA Specialist, Drug Substance to oversee GMP manufacturing, release, stability, validation, and lifecycle programs across drug substance and drug product. The role collaborates with outsourcing partners to ensure cGMP compliance
Praxis Precision Medicines, Inc. seeks a Director of Process Chemistry to lead drug substance activities across small molecule programs, driving clinical and commercial readiness. You will design products and processes supporting clinical testing and mature them
Sabin Vaccine Institute, Inc. is seeking a Director of Technical Project Management in R&D to lead a team of technical Project Managers spanning nonclinical, clinical, regulatory, and CMC activities. You will drive strategic planning, governance, and delivery,
Edison Scientific, Inc. is seeking an experienced CMC Regulatory Affairs Consultant / Regulatory Affairs Strategy Consultant for a flexible, part-time engagement. You will define the gold standard for regulatory content to ensure platform outputs meet current agency
When was the last time you achieved the impossible? If that thought feels overwhelming, you might want to pause here, but if it sparks excitement.read on In 2015, we pioneered a “moneyball for biotech” approach, pooling
Prellis Biologics, a Berkeley-based biotech, seeks a Principal Scientist for Therapeutic Antibody Characterization to lead analytical characterization of mAbs, bispecifics, and Fc-fusion proteins, guiding candidate selection and preclinical development. You will apply biophysical and analytical techniques
Aurion Biotech, Inc. in Cambridge, MA is seeking a Senior Scientist, Analytical Science & Technology to lead method transfers and validations at external CDMOs. You will author and review protocols, evaluate data, and ensure regulatory compliance