Senior Stability Scientist

2 weeks ago


New Brunswick, New Jersey, United States LanceSoft, Inc. Full time

Position Title: Senior Stability Scientist

Company: LanceSoft, Inc.

Role Overview:

The Senior Stability Scientist plays a crucial role in shaping the stability strategy for pharmaceutical products, ensuring compliance with industry standards and regulations.

Key Responsibilities:

  • Oversee the development and execution of stability programs for both oral and sterile drug products.
  • Lead the formulation of stability protocols and ensure their adherence to regulatory requirements.
  • Review and approve stability reports and documentation for regulatory submissions.

Essential Qualifications:

  • Minimum of 8 years of experience in managing stability programs for small molecule pharmaceuticals.
  • In-depth knowledge of ICH stability guidelines and cGMP regulations.
  • Proven track record in New Product Introduction processes.
  • Strong familiarity with regulatory CMC requirements for stability across various regions.
  • Hands-on experience in addressing QC deviations and interpreting analytical results.

Desired Skills:

  • Expertise in ICH Guidelines (Q1A, Q5C) and related regulatory frameworks.
  • Comprehensive understanding of cGMP regulations as outlined in 21CFR.
  • Proficient in US/EU/ROW regulatory requirements and industry best practices.
  • Solid knowledge of drug substance and product manufacturing processes.
  • Exceptional problem-solving skills with the ability to drive scientific initiatives.
  • Experience in conducting thorough investigations and generating quality-focused conclusions.
  • Proficient in statistical analysis of stability data and trend evaluation.
  • Experience managing external vendors for stability studies.
  • Significant exposure to health authority inspections related to stability programs.


  • New Brunswick, New Jersey, United States LanceSoft, Inc. Full time

    Position Title: Senior Stability ScientistCompany: LanceSoft, Inc.Job Overview:The Senior Stability Scientist plays a crucial role in formulating and overseeing the stability strategies for pharmaceutical products, specifically focusing on small molecules in both oral and sterile forms.Key Responsibilities:Develop and manage comprehensive stability product...

  • Sr. Scientist RC

    2 months ago


    New Brunswick, New Jersey, United States Rutgers University Full time

    Position Summary: Rutgers, The State University of New Jersey, is seeking a Sr. Scientist RC (Biomedical – Clinical Informatics Data Science -Data Engineer) for the Office of Advanced Research Computing ( OARC ). As part of a larger team of research scientists, the incumbent will support the Rutgers University biomedical research community, as well as...


  • New Brunswick, New Jersey, United States American Cybersystems Full time

    AMERICAN CYBERSYSTEMS INCPosition: Senior Automation ScientistLocation:New Brunswick, NJOverview:Innova Solutions is seeking a Senior Automation Scientist specializing in analytical laboratory instruments. This role is pivotal in implementing automation and robotic strategies within the Product Development sector.The successful candidate will be responsible...

  • Senior Manager

    4 weeks ago


    New Brunswick, New Jersey, United States Bristol Myers Squibb Full time

    Working with UsChallenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the...


  • New Brunswick, New Jersey, United States Bristol-Myers Squibb Full time

    Job SummaryBristol-Myers Squibb is seeking a highly motivated and detail-oriented Forensic Scientist Co-Op to join our team in New Brunswick, NJ. As a member of our Forensics and Innovative Technologies (FIT) group, you will have the opportunity to work with state-of-the-art analytical instruments and apply your knowledge to support manufacturing, patient...


  • New Brunswick, New Jersey, United States Bristol-Myers Squibb Full time

    Job SummaryBristol-Myers Squibb is seeking a highly motivated and detail-oriented Forensic Scientist Co-Op to join our team in New Brunswick, NJ. As a member of our Forensics and Innovative Technologies (FIT) group, you will have the opportunity to work with state-of-the-art analytical instruments and apply your skills to support manufacturing, patient...


  • New York, New York, United States Aer Full time

    We are seeking a Senior Data Scientist specialized in crypto to join our dynamic team in New York City, NY. We have a major crypto initiative we are starting and are looking for a data scientist with big data expertise who is either passionate for or has worked in crypto. This is a greenfield project so you will be driving outputs Day 1. The ideal candidate...

  • Associate Scientist

    2 months ago


    New Brunswick, New Jersey, United States Life Technologies (Thermo Fisher Scientific) Full time

    Work ScheduleStandard (Mon-Fri)Environmental ConditionsAdherence to all Good Manufacturing Practices (GMP) Safety Standards, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Standing for full shift Job Description Thermo Fisher's clinical research business is a leading global...


  • New York, New York, United States Columbia University Full time

    The Center for Translational & Computational Neuroimmunology (CTCN), in the Department of Neurology at Columbia University Medical Center (CUMC) is a hub for large-scale translational human studies that integrate rigorous application of advanced laboratory techniques with cutting-edge computational methods. The CTCN includes a Neuroimmunology Core that is...

  • Senior Data Scientist

    4 weeks ago


    New York, New York, United States Marsh Full time

    Marsh is seeking candidates for our Senior Data Scientist, who will lead the development and implementation of models using advanced techniques in machine learning, predictive modeling, artificial intelligence, and natural language processing as applied in commercial insurance and risk management. This position consults with clients and colleagues on complex...

  • Senior Chemist

    2 days ago


    New Brunswick, New Jersey, United States Sun Pharmaceutical Industries Full time

    About the Role:We are seeking a highly skilled and experienced Senior Chemist to join our team at Sun Pharmaceutical Industries. As a Senior Chemist, you will be responsible for performing analytical testing for drug substances and various drug products, including tablets and capsules.Key Responsibilities:Perform routine analytical tests of pharmaceutical...


  • New Brunswick, New Jersey, United States Bristol-Myers Squibb Full time

    About the RoleBristol-Myers Squibb is seeking a highly motivated and detail-oriented Forensic Scientist Co-Op to join our team. As a Co-Op, you will have the opportunity to work with Subject Matter Experts in Forensics and Innovative Technologies (FIT) group, gaining hands-on experience with state-of-the-art analytical instruments and applying them for...

  • Senior Scientist

    6 days ago


    New York, New York, United States Joulé Full time

    Job Summary:The Senior Scientist will support the validation of novel therapeutic candidates by performing hands-on, bench-level assays involving both cell culture and tissue-based work, and as well as sample processing and analyses from in vivo animal studies.Key Responsibilities:Support cell culture platform work including iPSC-derived cells.Perform...


  • New York, New York, United States Zocdoc Full time

    About the CompanyZocdoc is a leading healthcare marketplace dedicated to empowering patients and transforming the healthcare experience. With a mission to give power to the patient, Zocdoc provides a platform that makes it easy to find and book in-person or virtual care across various specialties and insurance plans.Job Title: Senior Marketing Data...


  • New York, New York, United States ZocDoc Full time

    About the RoleZocdoc is a leading digital health marketplace that helps patients easily find and book the care they need. As a Senior Marketing Data Scientist, you will play a critical role in driving business growth and improving patient outcomes through data-driven insights.Key ResponsibilitiesAnalyze performance data to measure the impact of marketing...


  • New York, New York, United States Icahn School of Medicine at Mount Sinai Full time

    About the RoleWe are seeking a highly motivated and experienced Senior Scientist to join our expanding laboratory at the Icahn School of Medicine at Mount Sinai. As a key member of our team, you will play a critical role in advancing our research in genomics and proteomics, with a focus on developing new treatments for inflammatory skin disorders.Key...


  • New York, New York, United States Capital One Full time

    About This RoleAs a Senior Data Scientist, AI Innovator at Capital One, you will be part of a high-performing team that builds and ships state-of-the-art scalable architecture, AI/ML solutions for our award-winning mobile app. We partner with product, tech, and design teams to deliver app features that delight customers with dynamic and personalized...


  • New York, New York, United States Ordaos Bio Full time

    About the RoleOrdaos Bio is seeking a highly skilled Senior Research Scientist to lead our drug development efforts. As a key member of our team, you will be responsible for managing internal and external projects, developing and executing our drug discovery strategy, and collaborating with cross-functional teams to design and develop protein...


  • New York, New York, United States Luminary Group Full time

    Job OverviewLuminary Group is on the lookout for a talented and experienced Senior Biostatistical Scientist to join our esteemed client. In this pivotal role, you will provide essential statistical guidance and expertise for various research initiatives and clinical trials. Your collaboration with multidisciplinary teams will be vital in analyzing,...

  • Senior Scientist

    2 weeks ago


    New York, New York, United States Bristol-Myers Squibb Full time

    Position Overview:The Senior Scientist role focused on Antibody Drug Conjugate (ADC) technology is a pivotal position within our organization. This role is designed for a highly skilled and motivated individual who will contribute significantly to the advancement of ADC technologies.About Us:At Bristol Myers Squibb, we are committed to transforming patients'...