Director, Drug Product Development

🕒 January 12

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Apogee Therapeutics

WebsiteLinkedInAll Job Openings

51 - 200 employees

🧬 Biotechnology

💊 Pharmaceuticals

💰 $149M Series B on 2022-12

Biotechnology • Pharmaceuticals

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.

📋 Description

• Serve as a subject matter expert in PFS process development and manufacturing, providing technical guidance and strategic insights to cross-functional teams • Develop late-phase and commercial launch strategy for PFS development and manufacturing • Oversee drug product tech transfer, process development, and GMP manufacturing operations including person in plant support • Manage drug product CDMO adherence to deliverables, timelines, and performance in collaboration with Quality and Tech Ops team members • Support phase-appropriate strategies for drug product development, process transfer and scale-up, process characterization, process performance qualification (PPQ), and commercial readiness • Perform risk assessments using a QbD approach to define drug product process development and manufacturing strategies • Collaborate with drug product development and device teams to develop drug product presentations in vial, PFS, autoinjector, and advanced delivery technologies • Analyze manufacturing data and identify opportunities for process improvement and optimization • Support formulation and co-formulation development for protein therapeutics, including antibodies • Collaborate with Quality team and external partners to review and approve batch records, support investigations, and resolve deviations • Author and review regulatory submissions (IND, IMPD, BLA, briefing books, etc.)

🎯 Requirements

• Minimum of 10 years industry experience in drug product development and manufacturing • 5+ years of experience in clinical and/or commercial Good Manufacturing Practice (GMP) operations for PFS drug products, ensuring regulatory compliance and operational excellence across all phases of manufacturing • Demonstrated leadership in GMP manufacturing of combination products • PhD in relevant discipline (e.g. chemical engineering, biochemical engineering, chemistry or related field) or commensurate years of education and experience • Proven expertise in biologics drug product process development and aseptic manufacturing, preferably with a focus on monoclonal antibodies • Experience managing drug product CDMOs including tech transfers and oversight of GMP manufacturing operations • Experience with process performance qualification (PPQ) and commercialization of biologics • Experience with pre-approval inspection (PAI) readiness and support is preferred • Experience with drug product process extractables / leachables risk assessments is preferred • Demonstrated ability to collaborate with cross-functional stakeholders such as drug substance development, analytical development, supply chain, device development, clinical development, clinical operations, Quality, and Regulatory • Excellent communication skills with ability to clearly and concisely convey information to various stakeholders and cross-functional teams • Availability to participate in calls across international time zones • Position requires up to 25% travel including travel to domestic and international sites. In person attendance at Apogee All Hands meetings is required, typically held twice per year.

🏖️ 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 • 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