Our client, a leading pharmaceutical company, is hiring a Sr. Scientist consultant on a contract basis.
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.
The Scientist is required to have pharmaceutical analytical experience with late phase and/or commercial phase of business.
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.
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, a quick learner and a team player.
– Operate in a matrix team environment with collaboration with analytical development, global quality product leads, technical project teams, and regulatory groups etc. within client
-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
Additional Responsibilities Include
• 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 project, including technical evaluations of methods and data.
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.
• 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