Associate Director, CMC Operations and Project Management

20 hours ago

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Apogee Therapeutics

WebsiteLinkedInAll Job Openings

Immunology & Inflammation

51 - 200

💰 $149M Series B on 2022-12

Description

• About Apogee Therapeutics: Founded in 2022, offers a fast-paced, dynamic environment. • We develop differentiated biologics for treatments of inflammatory and immunology diseases. • Role Summary: Responsible for external DS or DP CDMO relationship and Project Management support for CMC Programs. • Key Responsibilities: Manage project aspects, identify risks, build CMC timelines, collaborate with teams, review invoices.

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