Regulatory Affairs CMC Director - Alameda, CA

The Director/ Senior Director of CMC QA will provide quality oversight/leadership for the CMC activities associated with Drug Products. · ...

The Director/ Senior Director of CMC QA will provide quality oversight/leadership for the CMC activities associated with Drug Products. · PhD in a scientific discipline with 7+ years or MS/BS degree with 10+ years of experience in Analytical Development/Quality Control in a GxP p ...

This role provides PSC Regulatory expertise and leadership for biologics and Bioconjugates commercial and development projects. · ...

Provide regulatory strategies appropriate for the stage of product development to PSC designed to maximize chances of successful and expedient registration with appropriate levels of CMC efficiency and flexibility. · Critically review and provide regulatory guidance to PSC for CM ...

Director of Drug Product at a global public biopharmaceutical company working on late-stage development and commercialization of sterile lyophilized injectables. · Lead drug product development strategies for late-stage and commercial small-molecule programs · Provide technical o ...

We are seeking a Director/Senior Director to lead our Chemistry, Manufacturing & Controls (CMC) strategy and implementation for various oligonucleotide assets in our portfolio. You will own all safety/quality, technical, and regulatory deliverables from late lead optimization thr ...

This is a high-impact role at the forefront of late-stage development and commercialization, focused mainly on their sterile, lyophilized injectable portfolio. · ...

Corcept is leading the way in the research and development of cortisol modulators. · ...

Maze Therapeutics busca a un Senior Director para liderar su estrategia analítica como parte de sus operaciones técnicas. · ...

+ Develop and execute a forward-thinking analytical strategy aligned to CMC plans, program phase, and company priorities. · + Own Maze approval of key analytical documents such as methods, · validation protocols/reports,stability protocols/reports,specifications, · change control ...

IDEAYA Biosciences is seeking an experienced Senior Director Regulatory CMC to support its therapeutic development programs. · Bachelor's degree in a Life Sciences discipline or equivalent. · Minimum of ten (10) years of experience in clinical regulatory and high potential for le ...

Jade Biosciences is focused on developing innovative therapies to address critical unmet needs in autoimmune diseases. · ...

A key development role in the CMC and Technical Operations organization that partners closely with Quality, Clinical Operations, Regulatory Affairs, Global Program and Project Management, Finance, Preclinical and Business Development to support all CMC development functions inclu ...

IDEAYA Biosciences is seeking an experienced leader to head Regulatory CMC. · The Senior Director, Regulatory Affairs CMC will support the CMC Regulatory Affairs function and be responsible for planning and executing the CMC regulatory strategies for IDEAYA's therapeutic developm ...

Maze Therapeutics busca un Senior Director para liderar el desarrollo analitico para sus programas pequeños molculas. El candidato deberá poseer experiencia previa en el sector farmaceutico y conocimientos sobre gmp e iso. · ...

The Director, CMC Project Management is a key development role in the CMC and Technical Operations organization. · This position partners closely with Quality, Clinical Operations, Regulatory Affairs, Global Program and Project Management, Finance, Preclinical,and Business Develo ...

We are seeking a Senior Director to lead our analytical strategy for early-phase small molecule programs in Technical Operations at Maze Therapeutics. · ...

We are seeking a highly experienced Director/Sr. Director of Chemistry, Manufacturing & Controls (CMC) to lead the development and implementation of our conjugated siRNA assets. · Invent & own the CMC roadmap—from IND-enabling tox supply to late-stage development —aligning with c ...

Maze Therapeutics busca un Senior Director para su equipo técnico. El candidato deberá liderar el análisis estratégico en fases tempranas de desarrollo. · ...

GondolaBio aims to leverage cutting-edge biological research to discover create test and deliver transformative medicines to treat patients who suffer from genetic diseases. · Invent & own the CMC roadmap—from IND-enabling tox supply to late-stage development · Lead DS & DP deve ...

The Director/Sr. Director will drive the end-to-end Chemistry, Manufacturing & Controls strategy and implementation for various conjugated siRNA assets in GondolaBio portfolio. · ...