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Director/Sr. Director, CMC

Mythictx
Waltham, MA Full Time
POSTED ON 1/17/2025
AVAILABLE BEFORE 4/17/2025

Sr. Director / Director, CMC

Company Overview :

Mythic Therapeutics is a privately held, clinical stage product-platform company building a pipeline of best-in-class antibody drug conjugates (ADCs) exhibiting a combination of unprecedented efficacy and therapeutic index. The Company’s FateControl engineering technology dramatically enhances ADC uptake in tumor cells with less impact on healthy cells, thereby safely increasing efficacy and opening up new therapeutic opportunities against a broad array of tumor targets.

At Mythic Therapeutics, we approach our work as entrepreneurs and innovators, blazing new trails that lead to better patient outcomes. If you share our passion and sense of urgency for developing effective cancer treatment options, and are looking for a dynamic, collaborative, and fulfilling work environment, we invite you to explore opportunities to join our team.

Job Summary :

Mythic Therapeutics is seeking a Sr. Director / Director, Chemistry, Manufacturing, and Control (CMC) to lead the technical development and delivery of scalable, robust manufacturing processes and analytical methods for our ADC drug candidates. The incumbent will have significant interactions and collaboration within the company and with external CDMOs, CROs, and other industrial partners. He / she will play a central role in bringing the company’s pipeline of products to the clinic.

The Director, CMC will report to the VP, Technical Operations and be a key member of the Technical Operations function leadership. The ideal candidate for this role is an individual who has significant CMC / technical development / external manufacturing management experience particularly in the area of ADC drug development.

Day to Day Responsibilities and Opportunities :

  • Lead the technical development, scale-up, and technology transfer of ADC manufacturing processes to support the company’s development programs.
  • Manage program-focused oversight of a network of CDMO and CRO partners as well as suppliers and vendors.
  • Apply Quality-by-Design principles to develop robust, scalable manufacturing process technologies.
  • Support regulatory strategy and activities, including authoring and reviewing relevant sections of global regulatory filings.

Required Qualifications and Skills :

  • A PhD or MSc in relevant life sciences or engineering field with at least 7 years (with a PhD) or 10 years (with an MSc) leadership experience in bioprocess, analytical, or bioanalytical development.
  • Proven experience in managing outsourced CDMO manufacturing, process development, or analytical development functions.
  • In-practice knowledge of relevant global regulatory requirements.
  • Strong interpersonal skills with the ability to motivate others.
  • Outstanding communication, analytical and organizational skills.
  • Highly collaborative team player who fosters open communication.
  • A passion for addressing the critical unmet medical needs of patients.
  • Personal Characteristics and Cultural Fit :

  • Good judgement : Strong problem solving, critical thinking and analytical skills.
  • Builds Relationships and Culture : Reputation for creating strong team cultures of quality, trust, and collaboration.
  • Execution mindset : Self-starter with a can-do mindset.
  • Mythic Therapeutics offers a fast-paced, entrepreneurial, team-focused work environment. We also offer a top-notch benefits package and work / life integration.

    Mythic Therapeutics is an equal opportunity employer. We do not discriminate on the basis of race, color, gender, gender identity, sexual orientation, age, religion, national or ethnic origin, disability, protected veteran status or any other basis protected by applicable law.

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