Associate Director - Manufacturing Science and Technology

March 19

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Apogee Therapeutics

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Apogee Therapeutics is a clinical stage biotechnology company focused on developing novel biologics for the treatment of inflammatory and immunology disorders. The company targets major markets in inflammatory and immune diseases such as atopic dermatitis, asthma, chronic obstructive pulmonary disease, eosinophilic esophagitis, and other related conditions. Apogee Therapeutics seeks to reshape the current standard of care by advancing antibody therapeutics that target well-established biological mechanisms, with the potential to address dermatological, respiratory, and gastroenterological issues. The company is committed to creating a psychologically safe workplace while prioritizing innovative treatment options for those living with these conditions.

Immunology & Inflammation

51 - 200 employees

🧬 Biotechnology

💊 Pharmaceuticals

💰 $149M Series B on 2022-12

📋 Description

•We are seeking a dynamic and experienced MSAT Associate Director to join the Development, Manufacturing, and Supply (DMS) team. •Reporting to the MSAT Director, this role will be responsible for working with CDMO(s) to execute late-stage development through launch/commercialization activities, enabling robust production of monoclonal antibody Drug Substance (DS). •This interdisciplinary position will provide stewardship of cell culture and/or purification, including scale-up from lab to manufacturing scale. •Support of manufacturing campaigns will be critical, including tech transfer, troubleshooting, deviation resolution, and campaign analysis activities.

🎯 Requirements

•BS, MS, PhD in relevant discipline (e.g., biology, biochemistry, biochemical engineering, or relevant field) or commensurate years of education and experience •8+ years biologics development and manufacturing experience •Expertise in either upstream or downstream tech transfer, process characterization, and commercialization •Experience with late phase development and commercialization of biologics within most of the 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 •Experience with design, execution, and analysis of process characterization studies •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 and willingness to travel up to 20% including to CDMOs •Ability to multi-task and keep pace with a fast-moving organization •Availability to participate in calls across multiple international time zones

🏖️ Benefits

•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 •Flexible PTO •Two, one-week company-wide shutdowns each year •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