Senior Manager - Product Stability and Expiry @Apogee Therapeutics

[Hiring] Senior Manager - Product Stability and Expiry @Apogee Therapeutics

Mar 26, 2025 - Apogee Therapeutics is hiring a remote Senior Manager - Product Stability and Expiry. 💸 Salary: $150,000 - $165,000 / year. 📍Location: USA.

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Role Description

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.

Qualifications

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%

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

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📍	Be aware of the location restriction for this remote position: USA
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Senior Manager - Product Stability and Expiry @Apogee Therapeutics

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Salary 💸 $150,000 - $165,000 / year	Remote Location USA
Job Type unspecified	Posted Mar 26, 2025

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📍	Be aware of the location restriction for this remote position: USA
‼	Beware of scams! When applying for jobs, you should NEVER have to pay anything. Learn more.

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[Hiring] Senior Manager - Product Stability and Expiry @Apogee Therapeutics

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