Director, CMC

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. 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 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, including development of integrated control strategies and implementation of technologies to support continued innovation. 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, engaging with internal and external technical experts to assure development and manufacturing execution for Mab, ADC drug substance, and drug product. As a member of the Product Development Team, the candidate will engage with cross-functional leadership to define and execute program strategy in alignment with Executive Leadership and Company objectives. 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. He/she will be excited to take on new challenges in an agile and entrepreneurial environment.

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 from candidate optimization/selection through preclinical development and clinical development. This will include guiding all CMC technical development including cell line development, both upstream and downstream antibody process development, conjugation process development, formulation and drug product development and process analytics (including data management).
• Managing program-focused oversight of 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. Maintain highly collaborative partnerships, while providing robust oversight of technical development, scale-up, technology transfer and manufacturing activities across the supply network.
• Apply Quality-by-Design principles to develop robust, scalable manufacturing process technologies and process analytics; build a deep understanding of the ADC manufacturing process platform (CQAs, CPPs, etc) and lead the development of effective, operational control strategies.
• Support regulatory strategy and activities, including authoring and reviewing relevant sections of global regulatory filings, as appropriate

Additional Responsibilities

• Leverage scientific/technical experience and project/program management skills to help advance Mythic’s development programs from discovery to clinical development with an eye toward commercial readiness.

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, or related areas.
• Proven experience in managing outsourced CDMO manufacturing, process development, or analytical development functions involving complex biological processes, including tech transfer; experience developing ADC manufacturing processes is a plus
• In-practice knowledge of relevant global regulatory requirements
• Strong interpersonal skills with the ability to motivate others, influence, and negotiate conflict situations
• Outstanding communication, analytical and organizational skills
• Is recognized as a thought leader within peer communities
• Highly collaborative team player who fosters open communication and facilitates mutual understanding and cooperation between all stakeholders
• Ability to navigate and be successful in a dynamic, fast-paced entrepreneurial environment
• 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 required to make evidence-based decisions. Good judgment, level-headed, neutral, and objective.

• Builds Relationships and Culture: Reputation for creating strong team cultures of quality, trust, and collaboration. Skilled at building and managing relationships cross-functionally and with external collaborators/partners, consultants, and vendors.

• Influences: Highly credible with various stakeholder group (internal employees up-down and across the organization, external collaborators, partners, and vendors and with site teams and investigators). Skilled at building and cultivating stakeholder confidence.

• Execution mindset: Self-starter with a can-do mindset and do what is needed to advance the company’s programs and initiatives. Drives self, individual and team accountability, develops and implements goals, objectives, measurable targets, and processes to achieve results.

• Demonstrated ability to work in a fast-paced, innovative biotech environment.

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.