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  • Senior Director, Analytical Development

    Jobgether

    Remote, United States

    …all applications and next steps. Our partner is looking for a Senior Director, Analytical Development based in the United…

  • Senior Director, Analytical Development

    Loyal

    Remote, United States

    The Senior Director, Analytical Development provides strategic leadership for all analytical development across Loyal’s pipeline and future commercial products. This is a hands-on role in a…

  • Director, Global Regulatory Project and Submission Management

    BeOne Medicines USA, Inc.

    Remote, United States

    General Description: The Director, Global Regulatory Project Management (Director, Global RPM) is a senior strategic leader responsible for supporting, influencing, translating, and…

  • Associate Director, Quality Control (56861)

    Praxis Precision Medicines

    Remote, United States

    Praxis is seeking a highly experienced, motivated, and innovative quality leader with strong experience in late-stage development and commercialization to join our Quality team as Associate…

  • Senior Director, Regulatory CMC (remote)

    Eli Lilly and Company

    Remote, United States

    As the Senior Director, Regulatory CMC, you will provide strategic and operational leadership for Regulatory CMC activities across the company's small molecule development programs.…

  • Senior Advisor, Regulatory Starting Material (remote)

    Lilly

    Remote, United States

    Centessa is currently seeking a Senior Advisor, Regulatory Starting Material. The individual in this Associate Director level role will lead the strategy, justification, and regulatory…

  • Senior Director, Analytical Development CMC

    Lilly

    Remote, United States

    Centessa’s CMC group is seeking a Senior Director of Analytical Development within the CMC group. The successful candidate will have hands-on experience in the development and validation of…

  • Senior Advisor, Regulatory Starting Material (remote)

    Eli Lilly and Company

    Remote, United States

    Centessa is currently seeking a Senior Advisor, Regulatory Starting Material. The individual in this Associate Director level role will lead the strategy, justification, and regulatory…

  • Senior Director, Leader of Quality Control (QC) Vaccine Development

    Albert B Sabin Vaccine Institute Inc

    Remote, United States

    • $216,000 to $243,000 USD / year

    …and commercialization. Working closely with Sabin’s existing Analytical Sciences and CMC Quality team and external laboratories/Contract Development and Manufacturing Organizations (CDMOs),…

  • Senior Manager, Cost Accounting

    Achieve Life Sciences

    Remote, United States

    • $150,000 to $175,000 USD / year

    Reporting to the Sr. Director of Finance & Accounting, the Senior Manager, Cost Accounting will own Achieve’s cost accounting function and help translate complex financial data into…

  • Director, Market Growth Strategy, Molecule to Market (CMC)

    Dotmatics

    Remote, United States

    Deep understanding of how CMC works day to day, including process and analytical development, manufacturing, technology transfer, lifecycle management, and regulatory filings

  • Senior Director, Regulatory Affairs CMC - Gene Therapy

    Insmed Gene Therapy LLC

    Remote, United States

    We’re looking for a Senior Director, Regulatory Affairs CMC – Gene Therapy to help us expand what’s possible for patients with serious diseases. Reporting to the VP, Regulatory Affairs…

  • Senior Manager, Regulatory Affairs

    Liquidia

    Remote, United States

    The Senior Manager, Regulatory Affairs supports the development and execution of regulatory strategy throughout clinical development and commercialization for assigned rare disease,…

  • Sr. / Exec. Dir. Process R&D

    Asymchem, Inc

    Remote, United States

    The Senior Director/ Executive Director, Small Molecule Process Chemistry serves as a senior scientific and strategic leader responsible for strengthening Asymchem's global small molecule…

  • Associate/ Director, Regulatory Affairs

    GondolaBio Service Co, Inc.

    Remote, United States

    • $211,000 to $250,000 USD / year

    Drive the global regulatory strategy for the program from clinical development through submission and approval, and translate that strategy into actionable, milestone-driven regulatory plans

  • Director, Gene Therapy CMC Lead

    Insmed Gene Therapy LLC

    Remote, United States

    We’re looking for a Director, Gene Therapy CMC Lead on the Manufacturing, Science & Technology team to help us expand what’s possible for patients with serious diseases. Reporting to the Sr…

  • Senior Director, Small Molecule Drug Substance Development

    Otsuka Pharmaceutical Development and Commercialization, Inc.

    Remote, United States

    The Senior Director, Small Molecule Drug Substance Development provides strategic, scientific, and operational leadership for the development, optimization, scale-up, and manufacture of…

  • Senior Director, Regulatory Affairs, CMC

    BeOne Medicines USA, Inc.

    Remote, United States

    BeOne is seeking an accomplished and strategic Senior Director, Regulatory CMC to lead a group and oversee CMC regulatory strategy and execution for our Antibody-Drug Conjugate (ADC)…

  • Associate Director, Global Regulatory Project and Submission Management

    BeOne Medicines USA, Inc.

    Remote, United States

    General Description: The Associate Director, Global Regulatory Project Management (AD, Global RPM) is a strategic leader responsible for translating and executing regulatory strategies…

  • Senior Manager / Associate Director, CMC Project Management, Pulmovant

    Pulmovant

    Remote, United States

    Summary: The Senior Manager / Associate Director, CMC Project Management will provide program and project management support for Pulmovant’s drug development programs, with a particular…

  • Principal Scientist, CMC Analytical

    Loyal

    Remote, United States

    You will be reporting to our Senior Director, Analytical Development

  • Senior Director, Biologics Drug Substance Development and Manufacturing

    Korsana Biosciences, Inc.

    Remote, United States

    The Senior Director, Biologics Drug Substance Development and Manufacturing, will provide program-specific leadership and subject matter expertise for drug substance development and…

  • Senior Director, Biologics Analytical Development and Quality Control

    Korsana Biosciences, Inc.

    Remote, United States

    The Senior Director, Biologics Analytical Development and Quality Control, will provide program-specific leadership and subject matter expertise for analytical development and quality…

  • Senior Director, Regulatory Affairs

    BeOne Medicines USA, Inc.

    Remote, United States

    The Senior Director, Regulatory Affairs is accountable for developing, implementing, shaping US regulatory direction and U.S. Food and Drug Administration engagement across a development…

  • Senior Director, Regulatory CMC

    Summit Therapeutics

    Remote, United States

    The Senior Director, Regulatory Affairs, CMC, is responsible for developing Regulatory Strategies and Submissions for Summit products globally. This role will provide regulatory strategy…

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