Remote Associate Director

Summary

Join Apogee Therapeutics, a fast-paced biotechnology company, as an Associate Director, Quality Control (QC) Compliance to build QC processes and procedures that adhere to regulatory standards and company policies. This role will be an important member of the TechOps team, managing multiple parallel activities supporting all stages of product development.

Requirements

• Advanced degree in a relevant discipline (e.g., analytical chemistry, biochemistry or related field) and 8+ years of QC-related experience with complex biologics, particularly monoclonal antibodies, spanning early and late-stage development (or equivalent combination of education and experience)
• In-depth knowledge of regulatory requirements and industry standards related to QC
• Deep experience with establishing and driving QC compliance processes, such as change control, CAPA, OOS/OOT investigations, and lab exceptions
• Proficiency in quality management systems (QMS) and related software
• Proven experience with audit processes, compliance management, and quality improvement initiatives
• Hands-on GMP QC experience in QC testing
• Experience partnering with CDMOs/external laboratories to establish and generate GMP QC data
• Excellent communication and interpersonal skills with an ability to collaborate effectively across functional lines
• Ability to work independently and multi-task in a fast-moving organization
• Availability 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 20%

Responsibilities

• Build and maintain QC infrastructure and compliance systems in partnership with subject matter experts to ensure phase-appropriate compliance with evolving industry regulations (e.g., FDA, EMA, ICH)
• Represent QC/Tech Ops in Change Control process development/improvement and facilitate all QC and TechOps change control
• Provide compliance review and approval of all QC documentation, including SOPs, CofAs, protocols, reports, investigations
• Lead OOS/OOT and complex testing investigations at CMDOs in partnership with subject matter experts
• Lead initiatives to enhance quality control processes and systems, driving efficiency and effectiveness
• Communicate compliance-related issues and updates to relevant stakeholders in a clear and concise manner

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