What are the responsibilities and job description for the Senior Engineering Scientist position at System One?
Title: Senior Engineering Scientist
Location: Summit, NJ
Start date: ASAP
Our 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.
System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time 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.
System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.
Location: Summit, NJ
Start date: ASAP
Our 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.
System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time 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.
System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.
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