Lead the QC Analytical Sciences team overseeing QC activities, method qualification, regulatory strategies, and partnerships with testing labs, while ensuring GMP compliance and data monitoring.
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 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
- Successfully exhibit Apogee’s C.O.R.E. 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 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.
To review our privacy policy, click here
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
Top Skills
Analytical Biochemistry
Gmp-Compliant Methods
Apogee Therapeutics Waltham, Massachusetts, USA Office
221 Crescent St , Waltham, MA , United States, 02453
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