Sr. CMC Project Manager

April 18

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Apogee Therapeutics

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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

💰 $149M Series B on 2022-12

Description

• We are seeking a Sr. CMC Project Manager to join the Technical Operations team at Apogee. This role is responsible for handling all CMC related documentation, managing the internal SharePoint site, and migration of Tech Ops documents to Veeva Quality System, as well as provide Project Management support for one or more 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 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 2 + years of biologics development and manufacturing experience • 3+ years of Technical Operations/CMC experience • Experience working with clinical stage candidates across all phases of Clinical Development (e.g., Ph 1 to Ph 3) • Experience with Process Characterization and PPQ a plus • Good technical knowledge of CMC development, CMC Regulatory Affairs, Quality, GMP requirements • Extensive knowledge of Smartsheet and Microsoft Project • Veeva experience is highly desired • 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