Associate Director – Manufacturing Science and Technology

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Apogee Therapeutics

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51 - 200 Mitarbeiter

🧬 Biotechnologie

💊 Pharmazie

💰 €149.000.000 Series B im 2022-12

Biotechnology • Pharmaceuticals

Apogee Therapeutics ist ein biopharmazeutisches Unternehmen im klinischen Stadium, das sich auf die Entwicklung neuartiger Biologika zur Behandlung von Entzündungs- und Immunerkrankungen konzentriert. Das Unternehmen zielt auf bedeutende Märkte in den Bereichen entzündliche und immunologische Erkrankungen ab, wie z. B. atopische Dermatitis, Asthma, chronisch obstruktive Lungenerkrankung, eosinophile Ösophagitis und andere verwandte Zustände. Apogee Therapeutics strebt an, den aktuellen Behandlungsstandard zu verändern, indem es Antikörpertherapeutika vorantreibt, die auf etablierte biologische Mechanismen abzielen und das Potenzial haben, dermatologische, respiratorische und gastroenterologische Probleme zu adressieren. Das Unternehmen ist dazu verpflichtet, ein psychologisch sicheres Arbeitsumfeld zu schaffen, während es innovative Behandlungsoptionen für Menschen mit diesen Erkrankungen priorisiert.

Beschreibung

• Develop and deliver phase-appropriate product understanding and control strategies using QbD framework and risk assessment • Support manufacture of clinical and commercial GMP DS throughout product lifecycle, including tech transfer, campaign analysis, and diagnostics • Author and review technical reports, master and executed batch records, working across internal team and with CDMO partners • Work closely with CDMO partners, providing technical oversight (including onsite Person in Plant support when required), and taking the lead in supporting investigations and resolving deviations • Analyze process and manufacturing data to understand and optimize process performance • Develop process characterization and PPQ strategies and documentation • Support regulatory activities including submissions and site inspections from preparation through execution • Liaise with DP, device development, and clinical supply chain as needed to ensure seamless end to end product delivery and robustness • Develop and maintain cost of good models that describe process and enable sensitivity analyses for process improvements • Collaborate closely with colleagues to ensure a seamless, highly integrated TechOps team • Author and review internal procedures, reports, and presentations, as needed

🎯 Anforderungen

• PhD in relevant discipline (e.g., biology, chemistry, biochemistry, bio/chemical engineering, or relevant field) or commensurate years of education and experience • 7+ years of biologics development and manufacturing experience • Experience with late phase development and commercialization of monoclonal antibodies within relevant process areas (upstream cell culture, downstream processing, solution prep, cleaning, automation, data systems, etc.) • Experience with tech transfer to CDMOs and supporting DS campaigns through scale up and validation/PPQ, including person in plant and pre-approval inspection support • Experience with process and economic modeling of DS manufacturing processes • Demonstrated aptitude in collaborating with cross-functional partners, including clinical development/operations, analytical development, QA, RA, and supply chain • Excellent communication skills with an ability to present to a variety of stakeholders and tailor message accordingly • Demonstrated growth mindset, willing to learn from others, and dedication to promoting a psychologically safe environment • Ability to multi-task and keep pace with a fast-moving organization • Successfully exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient and Egoless • Availability to participate in calls across multiple international time zones • Ability and willingness to travel up to 25%, including domestic and international sites, attendance at Apogee All Hands meetings is required, typically held twice per year

🏖️ Vorteile

• 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