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 estimated that norovirus causes nearly 700 million cases of illness and more than 200,000 deaths worldwide per year with significant additional economic and social burdens.
We are founded on the legacies of leading vaccine developers that inspire us to have a positive impact on human health and build a company that equalizes opportunity for people around the world by removing barriers of health inequity. Our aim is to have a global impact on human health; we believe the best way to achieve this impact is by developing novel vaccines for severe and life-threatening diseases. HIL-214 is our foundational vaccine candidate from which we are building the company.
Objectives / Overview:
We are seeking an Associate Director, Drug Substance Manufacturing to support our Upstream External Manufacturing team.
Responsibilities:
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Support of ongoing vaccine product lifecycle activities for Phase 3 and commercial drug substances and drug products, including tech transfer, PPQ, and commercial support.
- Author, review and data verification of technical documents, reports, and specifications.
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Review and approval of technical documents from CDMO: SOPs, experimental protocols, batch records, material specifications, validation protocols and reports.
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Systematization of large amount of technical documentation into GMP controlled records and documents.
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Overseeing, developing, and managing external and internal cross-functional activities required to advance HilleVax vaccine manufacturing goals.
- Interpretation and communication of technical information and risks internally and externally to facilitate decision making.
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Participation in risk assessments, deviations investigations and change control implementation as a technical assessor.
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Collaboration and communication with cross-functional team, including quality, supply chain, analytical, regulatory teams, on all aspects of product life cycle support.
- Development and implementation of proposals for continuous improvement, including manufacturing process performance and operational procedures.
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Author and manage internal quality documents not limited to Deviations, CAPAs, Change Controls etc.
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PhD with minimum of 8 years’ experience or MS with minimum of 10 years’ experience or BS with minimum of 12 years’ of experience in science or engineering, biopharmaceutical manufacturing.
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External manufacturing experience and effective working relationship with CDMOs preferred.
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Strong technical expertise in vaccines manufacture, recombinant protein production using Insect Cell culture and Baculovirus platform is highly desirable.
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Phase 2 / Phase 3 Technical experience with DS unit operations of cell culture scale-up, Baculovirus expansion, SU bioreactors and systems, depth filtration and downstream processes highly desirable
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Strong technical writing (authoring, review, revision, data verification) experience of manufacturing, quality, and regulatory documents.
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Working knowledge of regulatory requirements in accordance with cGMP and/or USDA manufacturing operations. Hands on experience with large scale biopharmaceutical processes and equipment, principles, and practices is preferred.
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Planning and execution of DS PPQ activities, including development of PVAC, validation protocols, validation reports.
- Planning and execution of risk assessments, according to FMEA model, including cross-contamination, product quality, raw materials risk assessments.
- Organizationally Savvy, highly motivated to learn and grow, can-do attitude, attention to details, and high ethical standards.
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Self-discipline and ability to adhere to and work under critical timelines.
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Positive and effective communication skills, problem solving skills, project management skills
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Agility and ability to adapt to changing priorities, work on multiple projects and new business processes in a high pace startup environment.
- Proficiency in Microsoft Office applications, such as Word, Excel, PowerPoint, Visio, Outlook.
Travel Requirements:-
Seeking Boston local candidates to be on-site 2-3 days per week.
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Willingness to travel to various meetings or client sites, including overnight trips. Some international travel may be required.
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Up to 25%.
HilleVax is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status. We welcome all to apply.