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 Senior Director in CMC Drug Substance, the Director of CMC Drug Substance Development will be part of THRD’s CMC DS development team and support our programs. The candidate for this role must be experienced in small molecule process chemistry, GMP manufacturing, driving development strategy and regulatory filing. The Director, CMC Drug Substance Development will have the opportunity to partner with CMC team members and cross-functional teams to ensure delivery of material and support non-clinical, clinical drug development, process chemistry R&D, technology transfer, and be part of our exciting biotech as we grow and scale.
Responsibilities
- Prepare SOWs (scope of work) and RFPs (request for proposal) for R&D and manufacturing activities including process optimization, technology transfer, GMP and non-GMP campaigns, polymorphism studies, purge of mutagenic impurities, DoE/QbD, and justification of regulatory starting materials.
- Review current manufacturing procedures, propose R&D direction in optimization and implement the optimized condition into manufacture.
- Manage all activities, review updates, interpret raw data and support problem-solving and troubleshooting for the tech transfer to a new CDMO. Review and organize process development and manufacturing reports.
- Deliver non-GMP and GMP products to support non-clinical and clinical development.
- Review master batch records and executive batch records and work with quality assurance manager to release drug substance under GMP.
- Organize historical data and impurity profile and learn the formation and purge of impurities in the process to support decision-making.
- Perform quality risk assessment to define critical process parameters (CPPs). Execute DoE and QbD studies to support late-stage development.
- Draft and review IND and IMPD quality CMC modules.
- Propose experiments and control strategies to address mutagenic impurities; perform the nitrosamine risk assessment.
- Propose strategies and experiments to justify the regulatory starting materials.
- Contribute to timeline and budget of projects to support CMC activities. Summarize progress and future R&D direction and present at project development team meetings.
- Provide process information to support formulation development.
- Work with CMC teams and consultants in drug substance, analytical chemistry, regulatory, and quality assurance to achieve CMC team goals.
- Travel to support and oversee GMP campaign of key steps or critical purification when needed, approximately 10~15% of the time.
Minimum Qualifications
- PhD in organic chemistry with +10 years or MS with +15 years in small molecule process chemistry, development, and non-GMP/GMP manufacturing.
- Hands-on experience in process chemistry research, development, scale-up and manufacturing projects.
- Ability to develop scalable process from bench scale to late-stage manufacturing.
- Experience in a virtual CMC environment.
- Ability to lead external R&D/manufacture projects and ensure delivery of product successfully.
- Ability to provide development strategy and propose required resources and timelines to execute development projects.
- Strong problem-solving skills in chemistry and manufacturing to support external projects.
- Experience in polymorphism, form conversion, and control strategy to produce the desired form robustly.
- Ability to design and propose studies to secure GMP manufacturing.
- Expert knowledge in analytical methods, techniques and data interpretation.
- Ability to draft IND CMC modules M2 and M3 to support regulatory filing.
- Experience in control strategy option 1~4 in mutagenic impurities and nitrosamine risk assessment according to ICH M7, related references and guidelines.
- Experience in justification of regulatory starting materials according to ICH Q11 Q&A and assessment by Merck in OPRD 2020, 24, 2762-2771.
- Experience in working in a multi-functional project team environment.
The salary range for this role is $194,000-$220,000
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.