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Director, Quality Control
About Apogee Therapeutics
Founded in 2022, Apogee Therapeutics, Inc. (Ticker: APGE) is a well-funded, Nasdaq listed company that offers the opportunity to work in a fast-paced, highly dynamic environment. At Apogee, you can actively contribute to shaping the company culture, take on various roles and responsibilities, and grow professionally.
Apogee Therapeutics, Inc. is a biotechnology company seeking to develop differentiated biologics for the treatment of atopic dermatitis, chronic obstructive pulmonary disease and other inflammatory and immunology indications with high unmet need. Our antibody programs are designed to potentially overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties. We seek to reshape the current standard of care for inflammatory and immune diseases because we believe people living with these diseases deserve the best possible treatment, and we refuse to stop at “good enough.”
We are a fast-paced company committed to building an exceptional company culture, founded on our C.O.R.E. values: Caring, Original, Resilient and Egoless.
If this sounds like you, keep reading!
Role Summary
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.
Key Responsibilities
- 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
Ideal Candidate
- 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%
The anticipated salary range for candidates for this role will be $200,000-$230,000. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography.
What We Offer
- 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
E-Verify Participation: As part of the I9 verification of authorization to work in the US, Apogee participates in E-Verify. To learn more about E-Verify please review this poster.
Apogee Therapeutics is proud to be an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law.
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