Senior Manager - Product Stability and Expiry

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.”

If this sounds like you, keep reading!

Role Summary

The Senior Manager – Product Stability and Expiry will oversee all stability studies, both development and GMP, across Apogee’s pipeline. This individual will work independently, have excellent organizational skills, and knowledge for statistical analysis used to analyze stability data. The role is integral to development, managing multiple parallel activities at all stages of product development.

 Key Responsibilities

• Develop and implement comprehensive stability testing strategies for monoclonal antibody (mAb) drug candidates in compliance with regulatory guidelines (e.g., ICH, FDA, EMA).
• Design and execute studies tailored to assess the stability of drug substances and products under various storage conditions, including accelerated and long-term storage.
• Evaluate stability data, using statistical analysis where appropriate, to establish product shelf-life, assess degradation pathways, and support regulatory submissions.
• Establish and lead the implementation of the stability module database, including system setup, validation, and ensuring it is fully operational to support product stability programs.
• Author documentation required for shelf-life justification and updates.
• Author and review stability sections for regulatory submissions, including IND, BLA and other global filings, ensuring compliance with regulatory guidelines and industry standards.
• Collaborate closely with cross-functional teams, including Process Development, Formulation, Manufacturing, QA, and Regulatory Affairs to ensure alignment of stability testing activities with overall project objectives and timelines.
• Prepare and deliver regular presentations and updates on stability data, trends, and findings to cross-functional teams and senior leadership.
• Stay abreast of scientific advancements, industry trends, regulatory updates related to stability testing and shelf-life assignment; serve as a subject matter expert on stability-related topics.
• Cultivate and maintain collaborative relationships with external partners contracted for stability testing.

Ideal Candidate

• Bachelor's or advanced degree in a relevant discipline (e.g., analytical chemistry, biochemistry or related field)
• 8+ years of pharmaceutical stability study and expiry management experience with complex biologics spanning early and late-stage development
• Knowledge of mAb structure-function relationships, degradation pathways, and factors influencing stability.
• Proficiency in analytical techniques relevant to mAb stability assessment, such as SEC, CE-SDS, and cIEF.
• Ability to work independently and effectively prioritize and manage multiple projects in a fast-paced environment.
• Familiarity with quality systems, cGMP regulations, and industry standards applicable to biopharmaceutical development.
• Experience managing CROs and CMOs
• Advanced statistical analysis skills
• Excellent communication skills with an ability to collaborate effectively across multidisciplinary teams
• 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%

The anticipated salary range for candidates for this role will be $150,000 -165,000 / year. 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

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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