Title: Senior Director, Head of Drug Substance

Position Overview:

Astria Therapeutics is dedicated to bringing hope with life-changing therapies to patients and families affected by allergic and immunological diseases. Astria’s pipeline includes our lead program, STAR-0215, a monoclonal antibody inhibitor of plasma kallikrein in clinical development for the treatment of hereditary angioedema, as well as STAR-0310, an OX40 monoclonal antibody antagonist currently in pre-clinical development for atopic dermatitis (AD) and being explored for other allergic and immunological diseases.

We are seeking an experienced leader to join Astria as the Senior Director, Head of Drug Substance. This role will oversee all drug substance process development for the company and will play a key role in driving the portfolio forward from early process development through late stage, including process characterization, validation, and commercialization. The Head of Drug Substance will have a pivotal role in providing strategy, shaping future organizational design, and innovation for the PharmSci organization. This senior leadership position requires a strategic thinker with a deep understanding of development, including late stage and commercialization, exceptional relationship building, technical skills, and the ability to collaborate cross-functionally to ensure efficient and effective development throughout our programs at Astria. This role will also oversee all aspects of drug substance process and technology development and be a key partner for the other PharmSci functional heads. This leader will initially manage a small team of vendors and internal reports with an opportunity for future growth and reports to the SVP of Pharmaceutical Sciences and Technical Operations.

Responsibilities:

• Lead drug substance team through preclinical and clinical development to commercialization across Astria’s pipeline. The role will have end to end responsibility of drug substance process development and technical support.
• Drive, build, and enhance strategic relationships with CDMO and other partners to advance Astria’s patient-guided drug development pipeline.
• Provide strategic and operational oversight, content creation of all regulatory documents and request for information.
• Partner cross functionally broadly throughout the organization including program teams, research, clinical development, medical affairs, new product planning, regulatory affairs, and corporate communications.
• Represent PharmSci holistically internally and externally as needed. Activities include due diligence, regulatory interactions, indication expansion, technology and innovation opportunities, project team and portfolio review committee.
• Develop, own, and execute against the operational budget pertaining to drug substance including manufacturing and process development.
• Provide mentorship and guidance to colleagues within the organization as well as outside of PharmSci.

Qualifications:

• Ph.D. in biochemical engineering, chemical engineering, biochemistry, or appropriate technical discipline with 12-15 years industrial bioprocess development/scale-up and manufacturing experience. The ideal candidate would have extensive experience in cell line and upstream process development. BS/MS with minimum of 15-20 years relevant industrial experience
• 5 years’ direct management experience is required.
• Strong leadership skills with experience defining the vision for the patient affairs function including strategic planning and supporting the development and growth of team members.
• Proven track record of building trusting, meaningful relationships with key stakeholders, cross functional organizations and CMDO vendors and partners
• Strong understanding of the legal, regulatory, and compliance environment, including a strong understanding of guidelines and best practices for drug substance development
• Highly collaborative, able to successfully develop and maintain strong working relationships cross-functionally with colleagues and with external stakeholders.
• Excellent communication and presentation skills
• Travel: 25% (domestic and international)

Astria’s Commitment:

At Astria, we are committed to building a diverse team where every Astrian is empowered to bring their authentic self to work. We embrace a patient-first, people-always culture in which all Astrians and our collaborators have a sense of belonging and receive the support they need to thrive. We invest in our people through our words, our actions, and our values. We are working to develop and implement initiatives that promote diversity, equity, and inclusion throughout the organization and foster a culture of openness, respect, and collaboration, where all voices are heard, and everyone is valued for their unique perspectives and contribution.

People are our greatest asset, and only with a diverse team can Astria shine brighter. Together we can bring our passion and compassion to the work of delivering life-changing therapies to patients, families and communities.