Head of Drug Substance/CMC Lead

3 weeks ago

Somerville, United States Cellarity Full time

What if you could join a rapidly growing company and play a critical role in bringing new medicines to patients through looking at and treating disease in a revolutionary way?


What this position is all about: Cellarity is seeking a highly motivated and innovative Director/Senior Director with expertise in the field of small molecule process chemistry to play a vital role in the company’s efforts to advance the company pipeline into clinical development. This role will oversee all drug substance process development for the company and will play a key role in driving the portfolio forward from late discovery and early process development through late stage, including process characterization, validation, and commercialization. The Head of Drug Substance will have a pivotal role in providing strategy, shaping future organizational design, and innovation for the organization. This senior leadership position requires a strategic thinker with a deep understanding of transitioning molecules from late discovery into clinical development, extensive experience in early phase clinical development and preferably late stage and commercialization experience. We are seeking someone with exceptional relationship building, technical skills, and the ability to collaborate cross-functionally to ensure efficient and effective development. This role will report into to the Head of Integrated Drug Creation.


What you would be responsible for:

  • Lead drug substance team through preclinical and clinical development to commercialization. The role will have end to end responsibility of drug substance process development and technical support.
  • There is potential for the role to assume leadership within CMC.
  • Drive, build, and enhance strategic relationships with CDMO and other partners to advance drug development pipeline.
  • Provide strategic and operational oversight, content creation of all regulatory documents and request for information.
  • Partner broadly throughout the organization including program teams, research, clinical development, medical affairs, new product planning, regulatory affairs, and corporate communications.
  • Represent drug substance holistically internally and externally as needed. Activities include due diligence, regulatory interactions, indication expansion, technology and innovation opportunities, project team and portfolio review committee.
  • Develop, own, and execute against the operational budget pertaining to drug substance including manufacturing and process development.
  • Provide mentorship and guidance to colleagues within the organization.


What experiences will you need:

  • PhD in Organic Chemistry with 15+ years of industry experience in process chemistry leadership roles with a demonstrated track record of success.
  • Strong understanding of the legal, regulatory, and compliance environment, including a strong understanding of guidelines and best practices for drug substance development.
  • Experience in regulatory filings.
  • Highly collaborative with an ability to successfully develop and maintain strong working relationships cross-functionally with key internal stakeholders and external CMDO vendors and partners.
  • Self-driven and demonstrated ability in working with a diverse team in a fast-entrepreneurial setting.
  • An extensive track record of presentations, publications, and patents.
  • Excellent communication and presentation skills.


What sets you apart:

  • Extensive experience leading CMC teams and representing CMC in broader project teams.
  • Strengths in the following areas: creativity, problem-solving, and managing relationships within a matrix project team environment.
  • A desire to be part of a highly innovative company aimed at transforming the lives of people with serious diseases.


What it’s like to work at Cellarity


At Cellarity, we

  • Push Boundaries: We create a legacy with breakthrough science in service of patients.
  • Inject Energy: We build strengths from different perspectives and tell it like it is
  • Own it: We transcend our job descriptions and relentlessly follow through on our commitments.
  • Go all out: We work quickly and with conviction.

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