Director, CMC

Mythic Therapeutics

Mythic Therapeutics

Waltham, MA, USA
Posted on Monday, October 30, 2023
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. We do so decisively and thoughtfully, drawing upon the decades of experience within our leadership team and scientific advisers. 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. Together, we are re-envisioning cancer therapy.

Job Summary:

Mythic Therapeutics is seeking a Director of Chemistry, Manufacturing and Controls (CMC) to join our growing Technical Operations team. In this role, they will support the technical development, and delivery of scalable, robust ADC manufacturing processes and analytical methods, and the reliable supply of high quality clinical trial material for the Company’s rapidly expanding global clinical trial programs.

They will use their scientific/technical expertise and program management/leadership skills to lead multi-disciplinary CMC teams that are supporting the advancement of our lead ADC program MYTX-011 through clinical trials, and progression of our pipeline ADC programs from preclinical development, to IND filing and into the clinic. This person will work with a range of internal functions (R&D, Quality, Clinical, Regulatory, and Finance) and external partners (CDMOs, CROs, and consultants), so the ability to build strong cross-functional relationships with all stakeholders will be critical to the success of this role.

This individual will have a solid scientific/technical background, ideally in the development of ADC therapeutics. They are energized by working in an entrepreneurial, scientifically rigorous, and results-oriented culture. They will know that ideas go nowhere without execution – and project management is often a company’s “secret sauce” that enables effective execution and ultimately leads to successful innovation. This position will report directly to the Vice President of Technical Operations.

Key Responsibilities

  • Work closely with executive and functional leadership and CMC team members in the development of CMC strategies, tactics, and plans.
  • Ensure CMC plans and deliverables are tightly aligned with corporate, functional, and Product Team goals.
  • Own the execution of program plans. Use advanced program management methodologies and best practices to lead CMC teams in the robust implementation of the CMC strategy.
  • Oversee contract external manufacturing, testing, and development partners ensuring CMC deliverables are timely, robust, and adequately de-risked across various time horizons.
  • Identify key risks and mitigation plans, and ensure timely communication with key stakeholders and Product Development Team.
  • Support development of budgets and long-range plans. Work closely with finance to track and manage CMC spend against budget. Proactively identify and communicate variances to plan, while watching for opportunities to reduce costs, accelerate timelines, or buy-down risk.
  • Support building and leading a network of CDMO and CRO partners as well as suppliers and vendors, to deliver expedited CMC development, external supply reliability and flexibility, and product quality. Establish highly collaborative partnerships, while providing robust oversight of technical development, scale-up, technology transfer and manufacturing activities across the supply network.
  • Support regulatory strategy and activities, including authoring and reviewing relevant sections of global regulatory filings, as appropriate.

Qualifications And Experience

  • A seasoned leader with outstanding program management skills and a history of developing winning project teams and team cultures in biotech/biopharma. Experience leading preclinical/clinical stage CMC teams is a must.
  • Must have a degree in a scientific/engineering discipline, BS/BASc with at least 12 years, MS/MASc with at least 8 years, or a PhD with at least 5 years and drug development experience in the pharmaceutical industry.
  • Track record of developing successful project strategies, plans and budgets and driving strong execution.
  • Proficiency in cGMP and other relevant global regulatory requirements. Experience working in a cGMP environment preferred.
  • Must have demonstrated experience in preparing and supporting CMC documentation enabling early clinical development (e.g. IND’s)
  • Experience managing/overseeing outsourced CMC activities highly desirable.
  • Able to view issues from multiple functional perspectives. Ability to work collaboratively and cross-functionally with research and development, technical operations, clinical, regulatory and finance is critical to success in this role.
  • Demonstrated willingness to challenge colleagues, debate issues in a collegial manner and provide sound guidance to program teams and management.
  • Possesses a business/operations mindset and experience in using metrics, scientific/technical data, competitive intelligence and advanced analytics to support decision making.

Leadership Skills, Personal Characteristics And Cultural Fit

  • Leadership: Proven ability to lead people and motivate teams to achieve objectives. Ability to influence others and to inspire confidence, respect and enthusiasm. Fosters a collaborative, team-oriented, high performance environment, instils a culture of accountability and strong commitment to achieving results.
  • Communication skills: Able to simplify and convey complex concepts and material, on technical and non-technical levels, both orally and in writing. Excellent listener. Communicates with credibility, confidence, professional maturity and good judgement. Able to clearly and comfortably communicate to stakeholders the strategic and operational results of the team.
  • Strategic capabilities: Able to develop program strategies and plans, based on experience and solid understanding of industry trends. Good business judgment and demonstrated creative problem-solving skills.
  • Results orientation: A strong individual contributor, with a hands-on style, an obvious sense of urgency, and a strong work ethic. Highly decisive, action-oriented and proactive by nature. Extremely well organized; flexible and responsive to change. Self-starter with a can-do mindset and willingness to “roll up the sleeves” and do what is needed to advance the company’s programs and initiatives. Demonstrated ability to work in a fast-paced, innovative biotech environment.
  • Collaboration skills: A superlative team player who works effectively in a team-based environment, readily establishes relationships, seeks input across the organization, achieves credibility with colleagues, builds consensus, and is able to gain alignment around key initiatives.

Mythic Therapeutics offers a fast-paced, entrepreneurial, team-focused work environment. We also offer a top-notch benefits package and work/life integration. Being part of the Mythic team allows you to become part of a small team that supports professional development while working together to meet the company goals.

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. Mythic does not accept unsolicited resumes from any source other than directly from candidates. Candidates will be required to show proof of being fully vaccinated against COVID-19 upon commencing employment. Reasonable accommodations will be considered on a case-by-case basis for exemptions to this requirement in accordance with applicable law.