Associate Director, CMC Operations and Project Management

December 3

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Apogee Therapeutics

WebsiteLinkedInAll Job Openings

Immunology & Inflammation

51 - 200 employees

🧬 Biotechnology

💊 Pharmaceuticals

💰 $149M Series B on 2022-12

Description

• We are seeking an Associate Director, CMC Operations and Project Management to join the Technical Operations team at Apogee. • This role will be responsible for handling all aspects of the external DS or DP CDMO relationship for one CMC Program 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 CMC Programs. • This position requires a self-starter, who can organize projects effectively in a fast-paced setting. If you are interested in utilizing your CMC Operations and Project Management expertise to deliver innovative medicine to the patients, enjoy the fast-paced environment, and thrive in a culture of growth and camaraderie – this role is for you.

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 PhIII to Commercial, such as DS or DP Process Characterization and PPQ is a must • Good technical knowledge of DS/DP Process development, Analytical, Regulatory, 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