Sr Director CMC Lead

1 week ago

Rockville, Maryland, United States Workforce Genetics Full time

We are looking for an experienced professional to fill the role of Director or Sr. Director-level Biologics CMC Lead focused on advancing projects related to neurological disorders within our company.

This role is dedicated to coordinating and executing large-scale molecular CMC activities to support project needs and company priorities.

Collaborating with Project Leaders and various departments such as Research, Clinical, Operations, and Regulatory, this position oversees global CMC operations.

The ideal candidate will leverage expertise in cellular and molecular biology, as well as biochemical knowledge, alongside up-to-date CMC technical, regulatory, and project management skills to facilitate the transition of new candidates into CMC development for human clinical trials.

What sets this Opportunity apart:

  • Rapidly growing company offering significant opportunities for career progression.
  • Engagement with a top-tier team and cutting-edge scientific research.
  • Exposure to acclaimed neuroscientists and industry leaders with substantial scientific and managerial backgrounds.
  • Operates primarily in the US but has a global presence, providing a valuable multinational work environment.
  • Encourages collaboration and cross-team communication to ensure streamlined operations across various units and locations, both internally and externally.

Key duties include:

  • Collaborating with the Executive Team to develop CMC strategic plans.
  • Leading Biologics programs in alignment with CMC strategies and Portfolio priorities.
  • Overseeing all CMC activities, including project planning, budgeting, vendor management, regulatory compliance, and more.
  • Utilizing project management techniques to maintain timelines, allocate resources, and address risks effectively.
  • Acting as a subject matter expert for vendor assessments and managing quality audits.
  • Coordinating with external partners for clinical supplies management and overseeing regulatory submissions.
  • Ensuring compliance with SOPs, policies, and quality assurance measures.
  • Identifying and addressing CMC risks and contributing to regulatory submissions.

Requirements and Experience:

  • Bachelor's, Master's, or Ph.D. in life sciences or related fields with relevant industry experience.
  • Specialization in Large Molecule CMC with hands-on experience in related activities.
  • Demonstrated knowledge of CMC processes, regulatory standards, and project management.
  • Proven track record in delivering CMC Biologics projects and at least 3 years of project management experience.
  • Familiarity with FDA-regulated environments and global project leadership.
  • Ability to cultivate productive relationships and communicate effectively in English and Mandarin.

Desired Qualifications:

  • Experience in FDA submissions and CMC regulatory writing.
  • Background in CDMO operations.

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