![Astria Therapeutics, Inc.](https://media.trabajo.org/img/noimg.jpg)
Senior Director, Head of Drug Substance
3 days ago
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 CDMO 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.
-
Senior Director, Head of Drug Substance
2 days ago
Boston, United States Astria Therapeutics, Inc. Full timeTitle: 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...
-
Senior Director, Drug Substance
1 month ago
Boston, United States PepGen Full timeJob DescriptionJob DescriptionSenior Director, Drug Substance Position Summary Reporting to the VP, Head of CMC Development, the Senior Director, Drug Substance will be responsible for leading the drug substance team in development and manufacturing as part of PepGen ́s CMC team. This person will manage the drug substance needs of PepGen’s growing...
-
Senior Director, Drug Substance
4 weeks ago
Boston, United States PepGen Full timeJob DescriptionJob DescriptionSenior Director, Drug Substance Position Summary Reporting to the VP, Head of CMC Development, the Senior Director, Drug Substance will be responsible for leading the drug substance team in development and manufacturing as part of PepGen ́s CMC team. This person will manage the drug substance needs of PepGen’s growing...
-
Senior Director, Drug Substance
2 weeks ago
Boston, United States PepGen Full timePosition Summary Reporting to the VP, Head of CMC Development, the Senior Director, Drug Substance will be responsible for leading the drug substance team in development and manufacturing as part of PepGen ́s CMC team. This person will manage the drug substance needs of PepGen’s growing pipeline. In addition, this position will be required to actively...
-
Senior Director, Drug Substance
2 weeks ago
Boston, United States PepGen Full timePosition Summary Reporting to the VP, Head of CMC Development, the Senior Director, Drug Substance will be responsible for leading the drug substance team in development and manufacturing as part of PepGen ́s CMC team. This person will manage the drug substance needs of PepGen’s growing pipeline. In addition, this position will be required to actively...
-
Director, Drug Substance Manufacturing
2 months ago
Boston, United States Third Rock Ventures Full timeAs a word, Rapport describes relationships characterized by understanding, communication, teamwork, and trust. We reflect those qualities in our daily work, where we operate as one committed team that captures the collective knowledge and experience of all our members to maximally improve patients' lives. And at a higher level we share an ambition and a...
-
Director, Drug Substance Manufacturing
4 weeks ago
Boston, United States Third Rock Ventures Full timeAs a word, Rapport describes relationships characterized by understanding, communication, teamwork, and trust. We reflect those qualities in our daily work, where we operate as one committed team that captures the collective knowledge and experience of all our members to maximally improve patients' lives. And at a higher level we share an ambition and a...
-
Director, Drug Substance Manufacturing
5 days ago
Boston, United States Rapport Therapeutics Full timeAs a word, Rapport describes relationships characterized by understanding, communication, teamwork, and trust. We reflect those qualities in our daily work, where we operate as one committed team that captures the collective knowledge and experience of all our members to maximally improve patients' lives. And at a higher level we share an ambition and a...
-
Boston, United States HireMinds Full timeOur vaccine client here in Boston, MA is growing and looking to add an Associate Director, Drug Substance Manufacturing to support their External Manufacturing team (Boston mix of onsite/WFH)! This role will support ongoing vaccine product lifecycle activities for Phase 3 and commercial drug substances and drug products, including tech transfer, PPQ, and...
-
Associate Director, Drug Substance Manufacturing
2 weeks ago
Boston, United States HireMinds Full timeOur vaccine client here in Boston, MA is growing and looking to add an Associate Director, Drug Substance Manufacturing to support their External Manufacturing team (Boston mix of onsite/WFH)! This role will support ongoing vaccine product lifecycle activities for Phase 3 and commercial drug substances and drug products, including tech transfer, PPQ, and...
-
Associate Director, Drug Substance Manufacturing
2 weeks ago
Boston, United States HireMinds Full timeOur vaccine client here in Boston, MA is growing and looking to add an Associate Director, Drug Substance Manufacturing to support their External Manufacturing team (Boston mix of onsite/WFH)! This role will support ongoing vaccine product lifecycle activities for Phase 3 and commercial drug substances and drug products, including tech transfer, PPQ, and...
-
Associate Director, Drug Substance Manufacturing
2 weeks ago
Boston, United States HireMinds Full timeOur vaccine client here in Boston, MA is growing and looking to add an Associate Director, Drug Substance Manufacturing to support their External Manufacturing team (Boston mix of onsite/WFH)! This role will support ongoing vaccine product lifecycle activities for Phase 3 and commercial drug substances and drug products, including tech transfer, PPQ, and...
-
Boston, United States Hillevax Full timeAssociate Director, Drug Substance Manufacturing HilleVax is a clinical-stage biopharmaceutical company focused on developing and commercializing novel vaccines. Our initial program, HIL-214, is a virus-like particle (VLP) based vaccine candidate for the prevention of moderate-to-severe acute gastroenteritis (AGE) caused by norovirus infection. It is...
-
Boston, United States Vertex Pharmaceuticals Full timeSenior Manager, Manufacturing Engineering, CMC Manufacturing, Drug Substance / Drug Product page is loaded Senior Manager, Manufacturing Engineering, CMC Manufacturing, Drug Substance / Drug Product Apply locations Boston, MA time type Full time posted on Posted 3 Days Ago job requisition id REQ-21821 Job Description Vertex's Biopharmaceutical Sciences and...
-
Associate Director, Drug Substance Manufacturing
3 weeks ago
Boston, United States HilleVax Full timeBoston, MA Full Time Technical Operations Experienced **Objectives / Overview**: We are seeking an Associate Director, Drug Substance Manufacturing to support our Upstream External Manufacturing team. **Responsibilities**: - Support of ongoing vaccine product lifecycle activities for Phase 3 and commercial drug substances and drug products, including...
-
Associate Director, Drug Substance Manufacturing
2 weeks ago
Boston, United States HilleVax, Inc. Full timeHilleVax is a clinical-stage biopharmaceutical company focused on developing and commercializing novel vaccines. Our initial program, HIL-214, is a virus-like particle (VLP) based vaccine candidate for the prevention of moderate-to-severe acute gastroenteritis (AGE) caused by norovirus infection. It is estimated that norovirus causes nearly 700 million cases...
-
Boston, United States HilleVax, Inc. Full timeHilleVax is a clinical-stage biopharmaceutical company focused on developing and commercializing novel vaccines. Our initial program, HIL-214, is a virus-like particle (VLP) based vaccine candidate for the prevention of moderate-to-severe acute gastroenteritis (AGE) caused by norovirus infection. It is estimated that norovirus causes nearly 700 million cases...
-
Associate Director, Drug Substance Manufacturing
2 weeks ago
Boston, United States HilleVax, Inc. Full timeHilleVax is a clinical-stage biopharmaceutical company focused on developing and commercializing novel vaccines. Our initial program, HIL-214, is a virus-like particle (VLP) based vaccine candidate for the prevention of moderate-to-severe acute gastroenteritis (AGE) caused by norovirus infection. It is estimated that norovirus causes nearly 700 million cases...
-
Senior Manager, Drug Substance Development
4 weeks ago
Boston, Massachusetts, United States Entrada Therapeutics Full timeThe OrganizationWhat's happening at Entrada Therapeutics? Entrada is a clinical-stage biopharmaceutical company aiming to transform the lives of patients by establishing a new class of medicines that engage intracellular targets that have long been considered inaccessible.Our Endosomal Escape Vehicle (EEVTM)-therapeutics are designed to enable the efficient...
-
Senior Manager, Drug Substance Development
1 month ago
Boston, United States Entrada Therapeutics Full timeThe Organization What's happening at Entrada Therapeutics? Entrada is a clinical–stage biopharmaceutical company aiming to transform the lives of patients by establishing a new class of medicines that engage intracellular targets that have long been considered inaccessible. Our Endosomal Escape Vehicle (EEV )–therapeutics are designed to enable the...