Job Description

Senior Scientist
Job Number: 21-11731
 
Be part of a company that delivers life-changing healthcare solutions. Eclaro is looking for a Senior Scientist for our client in Summit, NJ
 
Eclaro’s client is a leader in the Biopharmaceutical Industry, providing quality, innovative, and affordable medicines that make a difference in the lives of patients all over the world. If you’re up to the challenge, then take a chance at this rewarding opportunity!
 
Position Overview:
  • A scientist in the Analytical CMC Strategy group is expected to provide critical analytical support for commercialized and late-stage pharmaceutical (small molecule) products' lifecycle management.
  • Required to have pharmaceutical analytical experience with late phase and/or commercial phase of business.
  • Experience/expertise with regulatory filings, FDA and ICH guidance, and knowledge of Pharmacopoeia are expected.
  • Responsibilities include but are not limited to change control management, data summary and support for specification justification, the analytical CMC strategy critical review, support for questions and inquiries from regulatory for filings and post approval changes, reviewing dossier and related filing documents, presenting at a variety of meetings.
  • The scientist will work in Analytical Science and Technology (AST) group which resides in the Global Quality Organization.
  • This role requires ability to work in a highly matrixed environment.
 
Responsibilities:
  • Operate in a matrix team environment with collaboration with analytical development, global quality product leads, technical project teams, and regulatory groups etc. within Client.
  • Propose and execute strategies for the commercial stage drug substance and drug product specifications and methods
  • Support life cycle of regulatory filings, participates in preparation/reviewing of licensure applications, rest of world filings, follow-up measures, post-approval commitments and prior approval submissions
  • Support of analytical change controls
  • Responsible for gathering, interpretation and presentation of data to support decision making and product analytical strategies
  • Maintain effective partnerships with stakeholders from analytical development, Manufacturing Sciences and Technology, Supply Chain, Regulatory, Quality, Process Sciences, Drug Product Development, Project Management, and Manufacturing to deliver analytical strategies with a high probability of technical and regulatory success.
  • Share expertise with matrix teams in support of analytical topics related to FDA, MMA, ROW & Client filing review.
  • Support implementation of effective control strategy, analytical method and specification change control as needed throughout the Client network, third party manufacturing and outside testing labs.
  • Serve as a subject matter expert for project, including technical evaluations of methods and data.
 
Required Skills:
  • Comprehensive knowledge and experience of analytical methodologies used for the development and commercialization of pharmaceutical products. Demonstrate a broad expertise and experience in analytics routinely used for in-process, release and stability testing of drug substance and drug product, product characterization and strategies to establish process and product knowledge.
  • Extensive knowledge of the drug development process, analytical strategy and specification setting for drug substance and drug product
  • Familiar with FAD, ICH guidance and major Pharmacopoeias. Working knowledge of CMC regulations and cGMP requirements, as well as experience in supporting regulatory filings and post approval changes.
  • Strong communication and leadership skills in a highly interactive and fast paced environment.
  • Experience in working with cross-functional strategic teams and collaboration with internal and external partners.
 
Qualifications:
  • Education/Experience/ Licenses/Certifications:
    • A PhD, MS, or BS in Analytical Chemistry, Chemistry, or related disciplines with at least 1, 3, or 4 years of pharmaceutical industrial experience in relevant fields, respectively.
  • Physical Demands and Work Environment:
    • This is primarily a analytical subject expertise and analytical project management role for a commercial program, including office work, teleconferencing, computer work, and running meetings, as well as working with quality control analysts in a laboratory setting requiring:
      • Inside Work
      • Working Alone
      • Working with/around others
 
If hired, you will enjoy the following Eclaro Benefits:
  • 401k Retirement Savings Plan administered by Merrill Lynch
  • Commuter Check Pretax Commuter Benefits
  • Eligibility to purchase Medical, Dental & Vision Insurance through Eclaro
 
If interested, you may contact:
Jay Lucas
arjay.lucas@eclaro.com
6463571240
Jay Lucas | LinkedIn
 
Equal Opportunity Employer: Eclaro values diversity and does not discriminate based on Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
 

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