Senior Scientist – Analytical CMC

Alpha Consulting; Summit (NJ); Hybrid; USD 80,000 - 120,000; Full time

Job summary

An established industry player is seeking a Senior Scientist in Analytical CMC to join their dynamic team. This role is pivotal in providing critical analytical support for commercial change controls and regulatory filings. The ideal candidate will possess extensive knowledge of analytical methodologies and pharmaceutical industry experience. You will collaborate with cross-functional teams to ensure successful project execution and regulatory compliance. This innovative firm offers a hybrid work schedule, allowing you to balance office and remote work while contributing to impactful projects in the pharmaceutical sector. If you are passionate about analytical science and thrive in a fast-paced environment, this opportunity is perfect for you.

Qualifications

• Pharmaceutical industry experience with analytical methodologies is essential.
• Strong knowledge of FDA regulations and analytical strategy required.

Responsibilities

• Provide analytical support for commercial change controls and regulatory filings.
• Collaborate with cross-functional teams to deliver analytical strategies.

Skills

Analytical Methodologies

Pharmaceutical Analytical Experience

FDA and ICH Guidance

Communication Skills

Leadership Skills

Cross-functional Collaboration

Education

PhD in Analytical Chemistry

MS in Chemistry

BS in Chemistry

Tools

Regulatory Filings

Data Verification Tools

Job description

SENIOR SCIENTIST – ANALYTICAL CMC
SUMMIT, NJ

Job Description
SENIOR SCIENTIST – ANALYTICAL CMC
SUMMIT, NJ
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 FDA, 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 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 an 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: [e-mail]

ALPHA'S REQUIREMENT #23-00512
MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE

About the company

Alpha Consulting is a leading Information Technology and Pharmaceutical Recruitment Agency. Contact our IT recruiters for more information.