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Aura Biosciences
Brighton
Job Description Job Description Salary: ABOUT AURA: Aura Biosciences is a clinical stage oncology company. We are developing a novel technology platform based on virus-like drug conjugates (VDCs) to target and destroy cancer cells selectively, while activating the immune system to create long lasting anti-tumor immunity. We have a goal of developi
Job Source: Aura BiosciencesCasa Myrna
Boston, MA, United States
Casa Myrna is Greater Boston’s foremost provider of solutions to end domestic and dating violence. The agency operates three residential programs in Boston for survivors and children made homeless by domestic violence, a comprehensive range of advocacy and supportive services, and SafeLink, Massachusetts’ statewide 24/7 toll-free domestic violenc
Job Source: Casa MyrnaWolters Kluwer
Boston, MA, United States
The fast-growing Nursing Education team at Wolters Kluwer is seeking an Associate Director of Product Marketing to lead a dynamic team of product marketing professionals dedicated to improving nursing education and preparing the next generation of nurses to deliver safe and effective patient care. https://www.wolterskluwer.com/en/solutions/lippinc
Job Source: Wolters KluwerWolters Kluwer
Boston
The fast-growing Nursing Education team at Wolters Kluwer is seeking an Associate Director of Product Marketing to lead a dynamic team of product marketing professionals dedicated to improving nursing education and preparing the next generation of nurses to deliver safe and effective patient care. **olterskluwer.com/en/solutions/lippincott-nursing-
Job Source: Wolters KluwerWolters Kluwer
Boston, MA, United States
Location field must contain 'city, state' or a zip code to perform a radius search (e.g., Denver, CO or 46122 ). City and state must be separated by a comma followed by a space (e.g., Houston, TX ) The fast-growing Nursing Education team at Wolters Kluwer is seeking an Associate Director of Product Marketing to lead a dynamic team of product ma
Job Source: Wolters KluwerUpstream Bio
Waltham, MA, United States
Upstream Bio is developing innovative therapeutics in inflammation. We are a nimble company with solid financial backing that has raised $400M from high-quality investors. We are developing a monoclonal antibody targeting validated biology and are focused on our two Phase 2 studies in asthma and chronic rhinosinusitis with nasal polyps (CRSwNP) 202
Job Source: Upstream BioJudi by AG Mednet
Boston, MA, United States
Description The Director of Product plays a vital role at AG Mednet by leading the Product team and defining the strategic direction for the Product function. This role requires leveraging extensive experience and expertise to drive the development of client-driven value propositions, enhance the organization's market position, stay ahead of compet
Job Source: Judi by AG MednetAG Mednet
Boston, MA, United States
The Director of Product plays a vital role at AG Mednet by leading the Product team and defining the strategic direction for the Product function. This role requires leveraging extensive experience and expertise to drive the development of client-driven value propositions, enhance the organization's market position, stay ahead of competitors, and o
Job Source: AG MednetBoston, MA, United States
Role Summary
We are seeking an Associate Director, Product Stability and Expiry who will oversee all stability studies, both development and GMP, across Apogee’s pipeline. This individual will work independently, have excellent organizational skills, and knowledge of statistical analysis used to analyze stability data. The role is integral to development, managing multiple activities in parallel 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.
Author documentation required for shelf-life justification and updates.
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.
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
BS or advanced degree in a relevant discipline (e.g., analytical chemistry, biochemistry, or related field)
8+ years of pharmaceutical industry experience in stability study and expiry management of 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
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 25%
The anticipated salary range for candidates for this role will be $165,000-185,000 / 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.
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Email Alert for Associate Director, Product Stability and Expiry jobs in Boston, MA, United States
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