Senior Vice President - Chemistry, Manufacturing And Controls

About Third Harmonic Bio

Third Harmonic Bio is a biopharmaceutical company with a singular purpose: To create a breakthrough treatment for people living with severe allergy and inflammation - debilitating conditions that can take a significant toll on overall health and well-being.

We are developing a highly selective oral wild-type KIT inhibitor for millions of people living with chronic urticaria, severe asthma, and other mast cell-mediated diseases. Despite the availability of multiple approved medicines, there is an urgent need for new treatment options. We are grounded in our purpose of developing medicines to meaningfully improve the lives of the patients we serve.

We are seeking smart, fun, and talented individuals seeking a fast-paced environment where they can meaningfully contribute to building a successful company.

Our Values

Our values provide the foundation for our culture and our operating principles - and underly how we hold ourselves accountable and how we interact with each other, with our partners, and with the global medical and patient community.

Be Human

Relationships are important. Bring your full self to work and create space for others to do the same. Balance candor with empathy.

Own the Big Picture

Context is critical. Ground every decision and action in the entirety of what we are trying to achieve.

Go THRD

We hold ourselves to a higher standard. Work with urgency, purpose, and passion.

The Role

Reporting to the Chief Development Operations Officer, the SVP-Chemistry, Manufacturing, and Controls (CMC) will lead our CMC function and drive our product development efforts. This role will be responsible for overseeing the CMC strategy and execution to ensure the successful progression of our pipeline compounds from preclinical development through the full development cycle, as well as play a key leadership role in ensuring compliance with regulatory requirements and industry standards. This pivotal position has an opportunity to make a tangible impact on our dynamic and fast-growing organization as well as improve the lives of patients.

Responsibilities

• Establish vision and strategies for all aspects of CMC development and manufacturing, ensuring proper integration with Regulatory and Quality leadership and business systems

• Develop, lead and communicate phase-appropriate CMC strategies aligned with corporate goals and regulatory requirements, including product characterization, process development, validation, and clinical and commercial supply

• Lead, develop and mentor the Drug Substance and Drug Product team members, while driving efforts that support THRD's vision and mission

• Define the standards and oversee the selection and management of CDMOs, ensuring timely and cost-effective execution of development and manufacturing initiatives, including negotiation, project management, and performance evaluation

• Drive the optimization and scale-up of GMP manufacturing processes to support clinical and commercial supply needs, while maintaining product quality and regulatory compliance

• Collaborate with senior leadership and cross-functionally to integrate CMC considerations into overall product development plans and ensure alignment; identify risks and propose mitigations

• Lead initiatives to drive excellence and efficiency in progressing projects through development within CMC

• Stay current with emerging trends, technologies, and best practices in CMC development to inform decision-making and strategy development

• Represent the company in interactions with regulatory agencies, providing CMC expertise and support for regulatory submissions, inspections, and responses to inquiries

Minimum Qualifications

• Advanced degree (PhD, PharmD, MS) in Chemistry, Chemical/Biochemical Engineering, Pharmaceutical Sciences, or related discipline

• 20 years of relevant experience in pharmaceutical industry; biotech experience a plus, with at least, 10 years in leadership role, overseeing CMC function and team

• Strong understanding of regulatory requirements and guidelines governing CMC activities for pharmaceutical products • Strong technical background in CMC development and manufacture to support clinical programs and commercialization

• Excellent leadership, communication, and interpersonal skills, with the ability to effectively collaborate with cross-functional teams, senior leadership and external partners

• Demonstrated ability to think strategically, solve complex problems, and drive results in a fast-paced, dynamic environment

The base salary range for this role is $325,000-$370,000

All qualified applicants will receive consideration for employment without regard to race, sex color, religion, sexual orientation, gender identity, national origin, protected veteran status, or on the basis of disability.