Associate Director – Device Development

🕒 Maio 22

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Apogee Therapeutics

SiteLinkedInTodas as Vagas

51 - 200 funcionários

🧬 Biotecnologia

💊 Farmacêutico

💰 $149.000.000 Series B em 2022-12

Biotechnology • Pharmaceuticals

Apogee Therapeutics é uma empresa de biotecnologia em fase clínica focada no desenvolvimento de novos biológicos para o tratamento de distúrbios inflamatórios e imunológicos. A empresa mira mercados principais em doenças inflamatórias e imunológicas como dermatite atópica, asma, doença pulmonar obstrutiva crônica, esofagite eosinofílica e outras condições relacionadas. A Apogee Therapeutics busca reformular o padrão atual de cuidados ao avançar terapias com anticorpos que visam mecanismos biológicos bem estabelecidos, com potencial para atender questões dermatológicas, respiratórias e gastroenterológicas. A empresa está comprometida em criar um ambiente de trabalho psicologicamente seguro enquanto prioriza opções de tratamento inovadoras para aqueles que vivem com essas condições.

Descrição

• Technical lead on cross-functional teams responsible for development of combination products • Work with Quality function to develop and refine the combination product quality management system • Author product-specific Product Realization documentation, including User Requirements Specifications, Design and Development Inputs, and Design and Development Verification plans, protocols, and reports • Oversee test method development, test method validation and design verification at external labs • Establish human factors strategies and work with human factors service vendors to execute formative and summative HF studies for Design and Development Validation • Work with contract manufacturing organizations (CMOs) and contract research organizations (CROs) to meet development, manufacturing, and supply goals • Review and approve manufacturing protocols, master and executed batch records, validation plans and reports, and other cGMP documents • Support person-in-plant during manufacturing at CMOs, as needed • Serve as technical SME in root cause analysis and deviation investigations • Author, review, and approve development studies and technical reports • Collaborate effectively with cross-functional teams, including analytical development, supply chain, quality assurance, and regulatory affairs • Serve as technical SME on due diligence and business development opportunities • Communicate findings and progress through presentations and reports • Author and support regulatory submissions (IND, IMPD, amendments, BLA, etc.)

🎯 Requisitos

• Minimum 10 years of relevant industry experience, BS in mechanical engineering, biomedical engineering, chemical engineering or a related field required, advanced degree a plus • Must have hands-on experience in developing biologic/device combination products, specifically with prefilled syringe with needle safety device, autoinjector, and/or on-body injector. Experience should include: • Development of User Requirements and Design Input Requirements • Establishing statistical acceptance criteria based on reliability and confidence intervals • Statistical analysis of test data • Test Method Validation • Design and Development Verification plans, protocols, and reports • Design and Development Validation and Design and Development Transfer • Process Validation • Experience in late phase clinical development and commercialization of combination products • Must have sound understanding of current regulatory requirements and industry standards for biologic/device combination products, including 21 CFR Part 4, 21CFR820.10/ISO 13485 • Experience working with external device suppliers, CMOs and cGMP manufacturing facilities • Experience performing risk management per ISO 14971 • Experience with execution of root cause analysis and investigations • Strong communication and presentation skills • Availability to participate in calls across multiple international time zones • Ability to travel up to 25% travel including mandatory in-person attendance at All Hands meetings typically held twice per year as well as domestically and internationally to vendor / CDMO sites • Ability to work independently and multi-task in a fast-moving organization • Successfully exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient and Egoless

🏖️ Benefícios

• A great culture, grounded in our C.O.R.E. values: Caring, Original, Resilient and Egoless • Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly • Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits • We provide competitive time off, including three weeks PTO, two one-week company-wide shutdowns a year and dedicated paid sick leave • Commitment to growing you professionally and providing access to resources to further your development • Apogee offers regular all team, in-person meetings to build relationships and problem solve