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Senior Scientist Analytical CMC

SUMMIT, NJ 07901

Posted: 03/10/2023 Job Number: 23313827

Job Description

Hybrid Work Schedule 50% Onsite
Must have: Pharmaceutical Industry Analytical Experience.

Required Skills:
  • A PhD, MS, or BS in Analytical Chemistry, Chemistry, or related disciplines with 1-4 years of Pharmaceutical industrial experience in relevant fields.
  • Comprehensive knowledge and experience of Analytical Methodologies used for the development and commercialization of Pharmaceutical products.
  • Required to have Pharmaceutical Analytical experience with late phase and/or commercial phase of business
  • Familiar with FAD, ICH guidance and major Pharmacopoeias .
  • 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.
  • 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.

Project Description:
  • A scientist in the Analytical CMC Strategy group is expected to provide critical analytical support for commercial change controls, RoW filing support, and commercial analytical activities.
  • Experience with change controls, method validation and transfer, and some knowledge in regulatory filings, FDA and ICH guidance, and knowledge of Pharmacopoeia are highly valued.
  • Responsibilities include but are not limited to change control management, method review and summary, data verification, data summary and support for specification justification, reviewing dossier and related filing documents.
  • Work in the Analytical Science and Technology (AST) group which resides in the Global Quality Organization.
  • Operate in a matrix team environment with collaboration with analytical development, global quality product leads, technical project teams, and regulatory groups etc. Within the Client's company.
  • Support of commercial analytical change controls.
  • 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.
  • Gathering, interpretation and presentation of data to support decision making.
  • 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 & PAS filing review.
  • Support implementation of effective control strategy, analytical method and specification change control as needed throughout the Client's network, third party manufacturing and outside testing labs.
  • Serve as a subject matter expert for project, including technical evaluations of methods and data.

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

This 12+ month position starts ASAP.

Please E-MAIL your resume (attachment to email) with rate and availability to Loren: loren@alphaconsulting.Com


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Loren Graham

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