Apogee Therapeutics
Apogee Therapeutics, LLC is a biotechnology company advancing novel, potentially best-in-class therapies to address the needs of the millions of people living with immunological and inflammatory disorders.
Immunology & Inflammation
51 - 200
Associate Director - CMC Project Management
2 days ago
🏡 Remote – Anywhere in California
Apogee Therapeutics
Apogee Therapeutics, LLC is a biotechnology company advancing novel, potentially best-in-class therapies to address the needs of the millions of people living with immunological and inflammatory disorders.
Immunology & Inflammation
51 - 200
Description
• We are seeking an Associate Director, CMC Project Management to join the Technical Operations team at Apogee • This role will be responsible for handling all aspects of the external CDMO relationship for one of our CMC Programs including, but not limited to: meetings, timelines, tech transfer, DS/DP manufacturing, all related documentation via managing the exchange of information via internal and external SharePoint sites, as well as provide Project Management support for our other CMC Programs • The individual hired will also focus on operational excellence creating efficiencies and standardizations to ensure streamlined processes • This position requires a self-starter, who can organize projects effectively in a fast-paced setting
Requirements
• Bachelor’s degree in science • 10+ years of experience in biotech or pharmaceutical industry with 5-8 years of Biologics development and manufacturing experience • 5+ years of Technical Operations/CMC Project Management experience • Experience working with clinical stage candidates across all phases of Clinical Development (e.g., PhI to PhIII). Experience with Late Stage (Process Characterization and PPQ) is a plus • Good technical knowledge of CMC development, CMC Regulatory Affairs, Quality, GMP requirements and device • High level of expertise of Smartsheet, Microsoft Project, OnePager, and Office Timeline • Assertive and proactive • Highly organized with meticulous attention to detail • Ability to multi-task and keep pace with a fast-moving organization • Ability to participate in calls across multiple international time zones • Successfully exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient and Egoless • Ability and willingness to travel up to 15% to company All Hands Meetings, and the Apogee lab in Boston
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
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