Senior Director, Quality Control Analytical Sciences

Apogee Therapeutics; Poland; Remote; PLN 889,000 - 944,000; Full time

Job summary

A biotechnology company is seeking a Senior Director of Quality Control Analytical Sciences to lead the QC activities across its pipeline. The successful candidate will have over 15 years of experience in QC and a PhD in a relevant discipline. Responsibilities include managing QC teams and developing regulatory strategies. The role offers a competitive salary range of $245,000-$260,000 along with a culture grounded in CORE values.

Benefits

Market competitive compensation

Flexible PTO

Performance bonus

Equity grant opportunities

Professional development resources

Qualifications

• 15+ years of experience with complex biologics, particularly monoclonal antibodies.
• Demonstrated alignment with Apogee’s CORE values.
• Ability and willingness to travel up to 30%.

Responsibilities

• Lead QC Analytical Sciences team, ensure QC activities for pipeline programs.
• Develop analytical regulatory strategies and prepare Module 3 documents.
• Monitor data trends and troubleshoot QC method performance.

Skills

PhD in relevant discipline

15+ years of QC experience

Proven people leader

Excellent communicator

Experience with regulatory filings

Deep knowledge of global regulatory requirements

Ability to travel up to 30%

Education

PhD in analytical biochemistry or relevant field

Job description

Senior Director, Quality Control Analytical Sciences

Remote

Overview

About Apogee Therapeutics

Founded in 2022, Apogee Therapeutics, Inc. (Ticker: APGE) is a Nasdaq-listed company that offers the opportunity to work in a fast-paced, dynamic environment. At Apogee, you can contribute to shaping the company culture, take on multiple roles, 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 aim 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.

We are a fast-paced company committed to building an exceptional company culture, founded on our CORE values: Caring, Original, Resilient and Egoless.

If this sounds like you, keep reading!

Role Summary

We are seeking a Senior Director, Quality Control (QC) Analytical Sciences, to lead QC Analytical Sciences across Apogee’s pipeline. This individual will be an important leader driving the TechOps and CMC Regulatory strategy, reporting to the VP of Analytical Development and Quality Control.

Key Responsibilities

• Lead QC Analytical Sciences team, responsible for QC activities for all pipeline programs including strategies for phase-appropriate method qualification, validation, and transfer for drug substance, drug product, and drug-device combination testing; in-process/release/stability testing; specification justification and maintenance; shelf-life management; and critical documentation
• Partner with new and existing external QC testing labs and CDMOs, managing relationships and all relevant activities in collaboration with TechOps Program Management, Quality Assurance, and Manufacturing
• Develop analytical regulatory strategies and prepare relevant Module 3 regulatory documents
• Contribute to a mature QC infrastructure, implementing processes and procedures to support the development of therapeutic candidates in a GMP-compliant manner
• Monitor data trends, troubleshoot QC method performance, and investigate OOT/OOS results

Ideal Candidate

• PhD in relevant discipline (e.g., analytical biochemistry or relevant field)
• 15+ years of QC experience with complex biologics, particularly monoclonal antibodies, spanning late-stage development and commercialization
• Proven people leader with a growth mindset, willing to learn from others, and dedication to promoting a psychologically safe environment
• Excellent communicator with an ability to present to and be understood by a variety of stakeholders and tailor message accordingly
• Experience with regulatory filing preparation and messaging across global jurisdictions
• Deep knowledge and understanding of relevant global regulatory guidance and requirements
• Ability to keep pace with a fast-moving organization
• Availability to participate in calls across multiple international time zones
• Demonstrated alignment with Apogee’s CORE values: Caring, Original, Resilient and Egoless
• Ability and willingness to travel up to 30%

The anticipated salary range for candidates for this role will be $245,000-$260,000. 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 CORE values: Caring, Original, Resilient and Egoless
• Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture, 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

EEO Statement: Apogee Therapeutics is 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.

Note: This posting includes voluntary self-identification information for compliance purposes as applicable by law.