 |
|
|
|
|
System One Holdings, LLC
|
Senior Analytical Scientist |
 |
| Post Date: | May 23, 2023 | Type: | Full-Time |
| Start Date: | 5/23/2023 | Salary: | |
| Location: | US-NJ-Summit
| Job Reference: | 9f9c38a2f93129e9a7cb93de2 |
|
Skills:
Job Description:
Title: Senior Analytical Scientist Location: Summit, NJStart date: ASAPOur client is looking for the following:Responsibilities: Operate in a matrix team environment with collaboration with analytical development, global quality product leads, technical project teams, and regulatory groups etc. 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 BMS network, third party manufacturing and outside testing labs. Serve as a subject matter expert for project, including technical evaluations of methods and data. With the following credentials:Requirements: 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. 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 FDA, 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 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 other System One offers eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.
|
Contact Information
System One Holdings, LLC
|
|
|
|
| |
Please help us spread the word
about BiologyJobs.com by telling
any organization you know that hires employees with a background in biology that they can advertise their open positions online at BiologyJobs.com for only $1 per day with unlimited job postings and resume database access plus their organization's profile and logo featured online. You can't beat the affordable advertising rates of Biology Jobs .com combined with the highly tartgeted traffic that your job postings will recieve compared to other online job board services.
Whether you are working on your degree, or your have completed your B.A.
(bachelor of arts) B.S. ( bachelor of science ) M.S.( master of science ), M.A. ( master of arts ),or
Ph.D ( doctorate of philosophy ) degree , and you are looking for a postdoctoral ( postdoc ) job, Biology Jobs .com has job openings posted online at various times for all levels of Biology Jobs from volunteer positions to postdoctoral research jobs to tenured professors, positions with top biotechnology companies and everything in between. |
|
|
|
|
|
|
|
|
