Senior/Principal ARD Scientist

6 hours ago


Plainfield NJ United States Kashiv Biosciences, LLC Full time

Description

The Senior/Principal Scientist will be part of the CMC ARD team responsible for drug product related CMC strategy development for clinical stage biosimilar and conjugate biologics programs. The individual will be proficient in multiple analytical techniques as well as with the latest ICH, FDA and EMA regulatory guidance on pharmaceutical development. A successful candidate will act as an intellectual resource in area of expertise by supporting analytical method development, tech-transfer, and validation.

Key responsibilities include:

  1. Provide scientific guidance and leadership on phase appropriate methods development, optimization, qualification, technical transfer, product comparability, extended characterization, and stability programs.
  2. Conduct characterization, investigation, and troubleshooting to provide key insights and understanding for drug product CQA assessment.
  3. Work on analytical method development , optimization, troubleshooting, qualification, and validation: LC (SEC, RP, IEX, HIC etc.), mass spectroscopy, capillary electrophoresis, MALS, and other large molecules characterization methods.
  4. Author experiment summaries, development reports, technical reports , operation and test method procedure documents, and provide review for documents comprising, but not limited to standard operating procedures, standard test methods, validation protocols and reports, etc.
  5. Actively participate in project team meetings , and communicate scientific data and concepts effectively through presentations, posters, and reports.
  6. Stay well-informed with advancements in separation sciences and large molecule characterization tools, and attend/present at scientific conferences.
  7. Communicate effectively with supervisors, colleagues, clients, and vendors.
  8. Maintain accurate, detailed, and timely records of method development and analytical data.
  9. Perform data review to ensure accuracy, completeness, and validity.

Requirements

  1. Education:
  • Ph.D. or Masters in Analytical Chemistry, Organic chemistry, Biochemistry, or related areas.
  • More than five years of experience in analytical method development and problem solving in the large molecules pharmaceutical industry is required for this position.
  • GMP experience is required.
Experience and Skills:
  • Must have fundamental understanding of analytical and biophysical characterization of mAbs and conjugate biologics.
  • Must have practical and hands-on experience with analytical instruments and method development using instruments such as HPLC/UPLC (SEC, RP, IEX, HIC etc.), mass spectroscopy capillary electrophoresis, MALS, and other large molecules characterization methods.
  • Experience with any or all of the following is considered advantageous: potency assay, plate-based assays, spectroscopy (UV-Vis, FT-IR, CD, and fluorescence).
  • Must be able to handle complex data interpretation and perform statistical analyses.
  • Familiarity with ICH guidelines and USP/EP pharmacopeia requirements.
  • Be able to work on multiple projects simultaneously.
  • Ability to be an individual contributor as well as collaborative team member.
  • Demonstrated ability to apply critical thinking and good problem-solving skills.
  • Strong willingness to learn and work proactively.
  • Good communication and technical writing skills.
  • Proficiency in Microsoft Office (Word, Excel, PowerPoint, Outlook) is must.

WORK ENVIRONMENT AND PHYSICAL DEMANDS:

  • Laboratory and controlled cleanroom space.
  • Cleanroom gowning may be required.
  • Standard noise levels expected with laboratory and manufacturing equipment.
  • Extended periods of standing and walking while working in the lab areas.
  • Must be able to lift 15 lbs.
  • High paced demanding environment to meet manufacturing schedules.
  • Travel as per need basis will be required, as part of method transfers or troubleshooting at manufacturing/QC sites.

Benefits:

  • Medical
  • Dental
  • Vision
  • 401K
  • Commuter/Transit
  • Student Loan Assistance
  • Cell Phone Allowance
#J-18808-Ljbffr

  • Summit, NJ, United States Bristol-Myers Squibb Full time

    Principal Scientist/Senior Principal Scientist, Form Characterization Working with Us Challenging. 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...


  • New Brunswick, NJ, United States Cfdv Full time

    Principal Scientist or Sr. Principal Scientist - Analytical Development Primary Location: New Brunswick, New Jersey or Summit, New Jersey We are seeking an experienced leader with strong analytical technical skills and a passion for strategic project leadership, mentoring others, and driving technical innovation to solve challenging problems. This role will...

  • Principal Scientist

    6 hours ago


    Bridgewater Township, NJ, United States Nestlé SA Full time

    Principal Innovation Sensory Insights Scientist At Nestlé Health Science, we believe that nutrition, science, and wellness must merge, not collide. Here, we embrace the intrinsic connections of these three pillars, harnessing their collective strength to empower healthier lives. Our broad product portfolio includes renowned brands like Garden of Life,...


  • Rahway, NJ, United States Merck Sharp & Dohme Full time

    Job Description Position Description: Senior Principal Scientist, Biostatistics (Hybrid) In BARDS (Biostatistics and Research Decision Sciences), a distinguished department within our company’s renowned Research and Development division, quantitative scientists, in partnership with other subject matter experts, apply state-of-the art scientific...


  • Denver, CO, United States Altamira Technologies Corp. Full time

    Altamira Technologies is seeking a Principal AI Scientist that possesses a mix of talent related to artificial intelligence / machine learning, data science, and traditional algorithms. In response to emergent customer requirements, the Principal AI Scientist leverages their understanding of national security missions to develop innovative and viable...


  • Sunnyvale, CA, United States Amazon Full time

    Job ID: 2829026 | Amazon.com Services LLC As a Principal Scientist in Ring and Blink, you will have deep subject matter expertise in the areas of Artificial Intelligence. You will work with multiple teams of scientists and engineers to translate business and functional requirements into concrete deliverables. More specifically, you will provide thought...


  • Juneau, AK, United States Oracle Full time

    At Oracle Cloud Infrastructure (OCI), we build the future of the cloud for Enterprises as a diverse team of fellow creators and inventors. We act with the speed and attitude of a start-up, with the scale and customer-focus of the leading enterprise software company in the world. The Oracle Cloud Infrastructure (OCI) Generative AI team is responsible for...


  • Newton, MA, United States Energy Jobline AZ Full time

    Principal Scientist Summary: Principal Scientists direct or manage projects with potentially high stakes, requiring thoughtful application of the appropriate technical disciplines and professional judgment. They oversee the scope and quality of service delivery from the beginning to the end of a project, by ensuring that the team is aware of, and addresses...


  • Raleigh, NC, United States LexisNexis Risk Solutions Full time

    Principal Data Scientist I Are you looking to develop your Data Scientist career? Do you enjoy coaching others to achieve high standards? Join us in shaping a more just world. About Us : LexisNexis, a part of RELX, is a leading global provider of legal, regulatory, and business information. We help customers increase productivity and improve...


  • Cambridge, MA, United States Apex Systems Full time

    Principal Scientist, Analytical Development Location : Cambridge, MA (Onsite)Science: Small Molecule Therapeutics Job Overview: The Principal Scientist in Analytical Development guides pharmaceutical advancements from inception through clinical stages and collaborates with internal and external partners. Primary Job Responsibilities: Develop specialized...


  • Richmond, VA, United States Capital One Full time

    Locations: VA - McLean, United States of America, McLean, Virginia Principal Data Scientist Principal Data Scientist – Consumer Credit Risk Management Models and Data Data is at the center of everything we do. As a startup, we disrupted the credit card industry by individually personalizing every credit card offer using statistical modeling and the...


  • Boulder, CO, United States SciPro Full time

    SciPro is excited to share an extraordinary opportunity with our key client in Colorado who is seeking a Principal Scientist, ADC/Antibody Characterization to join their innovative team.This is not just another role—our client is backed by a former C-Suite executive from one of the largest global software companies, and they are at the forefront of...


  • Portland, OR, United States Providence Health & Services Full time

    Description Responsible for independently performing research activity or specialized scientific service in support of a research laboratory and may act in the role of Principal Investigator. Conducts complete research projects of every scope, including responsibility for grant budgets, oversight of project staff, and ensuring compliance with regulatory...


  • Indianapolis, IN, United States IQVIA Laboratories Full time

    We are seeking a Principal Scientist, Biotransformation to join IQVIA Laboratories business in Indianapolis, IN . We hire passionate innovators who drive healthcare forward through thoughtful and inclusive collaboration. If you want to discover a career with greater purpose, join us as we transform and accelerate research and development. As a Principal...


  • Frederick, MD, United States Mackinnon Bruce International Full time

    We are working alongside our client in the Contract Clinical Research sector based in Maryland to hire a Principal Scientist (Bioanalytical).Who we areWe are a dynamic recruitment agency that has evolved since our first establishment in 2012. We work with several high-profile clients globally to help them source and retain top-tier talent. The clientOur...


  • Westwood, MA, United States enVerid Systems, Inc. Full time

    Position: Principal Material ScientistManager: Alex Goodwin, SVP Product and EngineeringLocation: Westwood, MA (Onsite)About the Company enVerid Systems is a leader in indoor air quality and energy efficiency for commercial buildings. Our Sorbent Ventilation Technology™ (SVT) improves indoor air quality, lowers a building’s carbon footprint, and reduces...

  • Senior Data Scientist

    6 hours ago


    Princeton, NJ, United States Smart and Rare Predictions Full time

    SRP is a big data company located in Princeton, NJ focused on Dynamic Pricing, run by seasoned alumni from Stanford University and Wharton. Job Description Title: Senior Data Scientist for a Stanford Startup Location: Princeton, NJ Employment Type: Full Time Job Requirements: A minimum of three years of experience working as a data scientist. Experience...

  • Senior Scientist

    8 hours ago


    Waltham, MA, United States Xilio Therapeutics Full time

    Senior Scientist / Principal Scientist, Biotherapeutic Engineering Xilio Therapeutics is a clinical-stage biotechnology company discovering and developing tumor-activated immuno-oncology (I-O) therapies with the goal of significantly improving outcomes for people living with cancer without the systemic side effects of current I-O treatments. The company is...

  • Principal Scientist

    8 hours ago


    Greenville, NC, United States Catalent Pharma Solutions Full time

    time left to apply End Date: December 30, 2024 (30 days left to apply) job requisition id 0086811 Principal Scientist Position Summary Catalent’s Greenville, N.C. facility specializes in end-to-end turn-key solutions for oral solid dosage forms, including integrated formulation development, analytical services, commercial manufacturing, and packaging....

  • Principal Scientist

    4 weeks ago


    Johns Creek, GA, United States Alcon Full time

    Are you ready to see your future like never before? If so, Alcon is the place for you! A career at Alcon is like no other. We are innovative. We are impactful. We are the largest eye care medical device company helping restore sight and allowing millions of people worldwide to see brilliantly. We have a long history of industry firsts and a diverse...