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Operations QA Manager - Commercial
Exelixis Inc
The Operations QA Manager - Commercial is responsible for the QA oversight of end-to-end, day-to-day GMP Operations at the Contract Manufacturing Organizations (CMOs) that generate Exelixis…
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Manager, Clinical Supply Chain
Rapport Therapeutics
Understanding of clinical development processes, GMP/GDP requirements, and global regulatory expectations for small molecule therapeutics.
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Director, Pharmaceutical Development
Erasca
…strategic leadership for the development and manufacture of small molecule drug products from early development through late-stage clinical development and product registration. This…
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Senior Manager, CMC Quality Control
Cytokinetics, Inc.
The Senior Manager, CMC Quality Control, is responsible for the execution and oversight of analytical development and quality control activities supporting late-stage development and…
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Global Regulatory CMC Manager # 26-26703
US Tech Solutions
The GRS-CMC Manager is responsible for content development, compilation, maintenance, and review of the Quality Module for regulatory submissions regarding: Clinical trial applications; New…
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Manager, CMC Quality, Pulmovant
Pulmovant
The Manager, CMC Quality will support quality oversight of Pulmovant's vendors to ensure that drug substance, drug product, and finished product are manufactured, tested, released, and…
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Product Complaints Quality Manager (Contract)
Vertex Pharmaceuticals
The Product Complaint Manager is responsible for supporting the Product Complaint Quality System at Vertex. This role will support quality activities associated within the Small Molecule,…
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Associate Director / Director, Nonclinical Toxicology
Treeline Biosciences
…as a key scientific and operational interface with external contract research organizations (CROs). The individual in this role will assume primary responsibility for the planning,…
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Senior Manager, Analytical Sciences
ORIC Pharmaceuticals
…control strategy, assembling data, and authoring an NDA for a small molecule commercial product is a…
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Senior Project Engineer
Pharmaron
The Senior Project Engineer will lead the planning, execution, and delivery of capital projects supporting small-molecule pharmaceutical manufacturing and research operations. This role…
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Project Manager / Senior Project Manager – API Manufacturing
Pharmaron
We're proud of the impact we make and just last year, we supported 887 discovery projects, 1,100+ CMC programs, and 1,397 clinical trials across all phases. Our teams are involved in…
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Senior Manager, Commercial Packaging (Small Molecule)
Neurocrine Biosciences Inc.
Leads cross-functional collaboration with internal stakeholders and contract packaging partners to establish packaging requirements, anticipate and mitigate complex risks, ensure regulatory…
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Senior Manager, Analytical Chemistry
Enliven Inc.
The Senior Manager, Analytical Chemistry will be a key member of Enliven Therapeuticss lean CMC organization and will independently drive assigned analytical CMC workstreams for…
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Manager, Analytical R&D
Granules Pharmaceuticals
Functional understanding of small molecule analytical development and associated regulatory and quality requirements.
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Stability Coordinator/Manager
Viking Therapeutics, Inc.
The Stability Coordinator / Manager is responsible for planning, coordinating, and managing drug substance and drug product stability programs in support of Viking Therapeutics’ CMC…
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Director, Drug Product Development
BioCryst Pharmaceuticals, Inc.
Stay current with evolving CMC and global regulatory strategies for biologics and small‑molecule programs through literature and external networking, ensuring alignment with industry best…
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Assoc. Director, Analytical Development
BioCryst Pharmaceuticals, Inc.
Stay current with evolving CMC and global regulatory strategies for biologics and small‑molecule programs through literature and external networking, ensuring alignment with industry best…
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VP, Drug Substance
BioCryst Pharmaceuticals, Inc.
…enterprise drug substance strategy and execution across BioCryst’s small-molecule and biologics portfolio. The role provides end-to-end leadership for drug substance process and technology…
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(Contract) Senior Process Engineer
Kymanox
…product manufacturing across multiple product modalities (e.g., small molecule, biologics, gene therapies) including SOPs, CMC regulatory filings, manufacturing records, technical reports,…
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(Contract) Process Engineer
Kymanox
…product manufacturing across multiple product modalities (e.g., small molecule, biologics, gene therapies) including SOPs, CMC regulatory filings, manufacturing records, technical reports,…
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Analytical Development, Senior Manager
Intuitive
We are seeking an experienced analytical chemistry professional to provide strategic and technical support for small molecule programs progressing through late-stage development toward…
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Project Manager, CMC
Intuitive
The CMC Project Manager serves as a strategic and operational partner to Chemistry, Manufacturing, and Controls (CMC) leadership, providing integrated project management for development…
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Analytical Development Principal Scientist
Vertex Pharmaceuticals Inc (US)
Vertex is seeking an experienced scientist eager to help develop cutting-edge small molecules and the science underpinning the analytical control of their syntheses. As a member of the Drug…
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Senior Manager, Drug Substance
Rhythm Pharmaceuticals
Deep understanding of small molecule drug development; understanding of how CMC integrates and partners with associated functional areas such as Quality, Preclinical, Clinical, Regulatory,…
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Director, Nonclinical Toxicology Operations
Nurix
…filing, integrating chemistry, DMPK, pharmacology, safety, CMC, and regulatory timelines into a single credible…