Director - Quality Control

Yesterday

Apply Now

Receive Emails with Similar Jobs

Apogee Therapeutics

WebsiteLinkedInAll Job Openings

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 Director, Quality Control (QC) to lead and independently perform technical and operational aspects of QC across Apogee’s pipeline. This individual will be an important member of the TechOps team, managing multiple parallel activities at all stages of product development. • Develop strategies for and execute QC activities for all pipeline programs, including in-process/release/stability testing, specification justification and maintenance, and critical documentation. • Oversee new and existing external QC testing labs and CDMOs, managing relationships and all relevant activities and documentation; participate in external lab section due diligence visits and audits, as needed. • Manage GMP data, monitor trends, troubleshoot QC method performance, and investigate OOT/OOS results. • Oversee phase-appropriate method qualification, validation, and transfer for drug substance and drug product testing. • Manage reference standard and critical reagent qualification and inventory for multiple programs. • Contribute to analytical regulatory strategies and prepare relevant Module 3 regulatory documents. • Build and maintain a mature QC infrastructure, implementing procedures to support the development of therapeutic candidates in a GMP-compliant manner. • Work closely with TechOps Program management and external stakeholders to execute QC activities according to program needs.

Requirements

• Advanced degree in a relevant discipline (e.g., analytical chemistry, biochemistry or related field) and 10+ years of analytical development & quality control experience with complex biologics, particularly monoclonal antibodies, spanning early and late-stage development (or equivalent combination of education and experience). • Expertise/competence in several relevant analytical techniques such as HPLC, spectrophotometry, electrophoresis, ELISA, and cell-based bioassays. • Experience partnering with CDMOs/external laboratories to establish and generate GMP QC data. • Experience with processes supporting QC testing, such as reference standards and specifications. • Experience with regulatory filing preparation and messaging. • Knowledge and understanding of relevant global regulatory guidance and requirements. • Excellent communication 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 25%.

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.