Senior Manager - Product Stability and Expiry

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.