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SR Scientist

Posted 12 days ago

  • Expiry Date: 13 June 2022
  • Referral: 207704@accuick.com

Job description:

Position is onsite

Comments: Must Have: pharmaceutical industry analytical experience

Summary:

  • A scientist in the Analytical CMC Strategy group is expected to provide critical support for commercialized and late stage pharmaceutical (small molecule) products' lifecycle management.

  • Required to have extensive pharmaceutical analytical knowledge and experience with late stage and commercial projects.

  • Experience/expertise with change controls, pharmaceutical analysis, specification justifications, regulatory filings, familiar with FDA and ICH guidance, and knowledge of Pharmacopoeia are expected.

  • Responsibilities include but are not limited to managing change controls, establishing the analytical CMC strategy, enabling regulatory filings, managing the life cycle of specifications (methods and acceptance criteria), and authoring/reviewing responses to health authority questions on commercial products.

  • The scientist may serve as the point of contact for the Analytical Science and Technology (AST) group which resides in the Global Quality Organization.

  • This role requires great interpersonal skills and ability to work in highly matrix teams.

Duties/Responsibilities:

This position is for the Summit, NJ 

  • Lead/operate in a matrix team environment with collaboration with analytical development, global quality product leads, technical project teams, and regulatory groups.

  • Generate and execute strategies for the commercial stage drug substance and drug product methods and specifications

  • Support life cycle of regulatory filings, participates in drafting/ preparation 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

Additional Responsibilities Include

  • Create and 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 network, third party manufacturing and outside testing labs.

  • Serve as a subject matter expert for projects, including technical evaluations of methods and data.

Qualifications

Specific Knowledge, Skills, Abilities, etc:

  • 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.

Education/Experience/ Licenses/Certifications

  • A PhD, MS, or BS in Analytical Chemistry, Chemistry, or related disciplines with at least 3, 5, or 8 years of pharmaceutical industrial experience in relevant fields, respectively.

Physical Demands and Work Environment

  • This is This is primarily a coordination 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

  • Working with chemicals

About ASK: ASK Consulting is an award-winning technology and professional services recruiting firm servicing Fortune 500 organizations nationally. With 5 nationwide offices, two global delivery centers, and employees in 42 states-ASK Consulting connects people with amazing opportunities.

ASK Consulting is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all associates.