Senior Scientist / Manager Opportunities

Mulitple Senior Scientist opportunities available in Middlesex County, NJ.

1) A Senior Scientist (I) will, under general direction of a more senior staff member or director, be responsible for developing analytical methods for bulk drugs and finished dosage forms. The candidate must possess detailed knowledge of separation sciences and modern analytical instruments (focus on HPLC, GC and dissolution), and must be able to work with others to accomplish project goals.The individual is expected to work under GLP/GMPs and serve as a Study Director on GLP studies.

Requirements for Senior Scientist (I): Ph.D. in analytical chemistry or related field or MS and at least 4 years relevant experience.

2) A Senior Scientist (III) will provide technical/administrative leadership and expertise to the Methods Development/Validation Group in AR&D to support New Pharmaceutical Product Development. The incumbent will plan, monitor, and maintain project timelines to meet business needs, write protocols, develop and validate methods for the determination of active pharmaceutical ingredients (APIs), and finished dosage forms, apply state of the art approaches to ongoing projects, conduct activities in compliance with established regulatory requirements, serve as a Study Director on GLP studies.
• Provides technical/administrative leadership in planning, monitoring, and maintaining project timelines to meet business needs.
• Writes protocols, develop and validate methods for the determination of active pharmaceutical ingredients (APIs), and finished dosage forms, the methods development/validation area.
• Presents the results of your work internally and externally, and write reports that will be submitted to the FDA and other regulatory agencies worldwide.
• Conducts all activities in compliance with established regulatory requirements. Assist in the development of protocols to conduct studies in conjunction with others to meet regulatory requirements.
• Assists in development of strategic plans for departmental goals. Understands and complies with Safety, Good Laboratory Practices (GLPs), Company Affirmative Action, and Standard Operating Procedures and Policies.
• Records, evaluates, interprets and summarizes technical data. Develops and validates calculation procedures. Documents activities in technical notebooks or validated approved electronic media. Prepares reports, memos or regulatory documents with little direct guidance.
• Maximizes innovation by utilizing original concepts and creative thinking. Leads or participates in teams. Can shift priorities and projects as Company needs change. As needed, assists others as priorities change. Observes safety rules and works safely in the laboratory
• Functions as in-house consultant for area of expertise. Supports the Director of AR & D in managing the department.

Requirements for Senior Scientist (III): Ph.D. in chemical or biochemical sciences with 10+ years of industrial experience with supervisory responsibility. This position requires a good knowledge of GLP/cGMP regulations, ICH/VICH guidelines, and compendial methods. Incumbent must possess detailed knowledge of separation sciences and modern analytical instruments, and must be able to lead a diverse research team to complete a project goal; consequently must possess excellent interpersonal skills to collaborate with and direct others on major projects.

3) A Manager of Laboratory Sciences is responsible for managing analytical testing of products and components in conformance with FDA cGMP/QSR, ISO 13485, the Medical Device Directive and all other applicable regulatory agencies. This position manages the development of new test methods and their validation, the documentation related to Quality activities, and interaction with outside laboratories.

Requirements for Manager of Laboratory Sciences: Bachelor’s degree in Chemistry or Biochemistry; Master’s degree preferred.  A minimum of five years experience in a regulated Pharmaceutical Quality Control environment with experience in commercial release and product development, OOS and CAPA review and Quality Management activities are essential.  ICH and 21 CFR Part 211 experience is also required.Demonstrated skills and knowledge includes: Wet analytical chemistry; Size exclusion and reverse phase HPLC; Chromatography inclusive of Gel Permeation Chromatography (GPC); GC - headspace analysis; Moisture Content (Karl Fisher); NMR; MicrobiologyComputer/Software skills to include MS Office, Excel, and Visio.ISO experience to include ISO 13485 a plus.