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CURRENT JOB OPENINGS PHARMACEUTICAL |
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PRINCIPAL ENGINEER Ph.D. in Biochemical Engineering or related with 3-7 yrs. exp. Will supervise and provide direction to scientists, engineers and operating staff to the Purification Scale-up and Production group. Will provide technical leadership to the group/department and conduct project management. Prepare and review regulatory submission documents and assure GMP compliance. Assess and implement technology development and scale-up and provide leadership in product technology transfer. Also, for the same client we need someone with the same level of experience as the position listed above. This candidate will be working with pilot and commercial scale bioreactors for production of microbial cell lines Both positions are newly created. Salary is commensurate with experience.
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PROJECT MANAGERS [2] Client is Multi-Billion Dollar Generic Pharmaceutical Company based in NJ. Both positions are open due to the recent promotions of the previous Project Managers. Position Responsibilities: Manages project planning and coordination activities across all functions of the organization to ensure that all project tasks are completed against established objectives in ANDA Product Development and New Product Launch. Develops and maintains strong working relationships across all parts of the organization to facilitate timely and effective communication between R&D, manufacturing, marketing, legal, and other functions impacting achievement of project objectives. Prepares key documentation to ensure clear and concise reporting of project status. Leads project teams at specific phases of product development. Other Requirements: Thorough understanding of pharmaceutical product development from project inception to submission and product launch. Strong knowledge of project management principles; leadership ability; interpersonal, communication, problem solving, and facilitation skills. Task oriented and decisive with a high sense of urgency. Well developed presentation skills and ability to think strategically. Experience using Microsoft Project, Outlook, and other MS Office applications.
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BIOANALYTICAL CHEMIST
BS/MS with 3-7 years hands-on experience of quantitative analysis of drug and metabolite in Biological fluids. Experience should include manual or automated sample extraction techniques, HPLC and preferred 2+ years of LC/MS/MS . Candidates should have adequate problem solving abilities of instrumentation and method. Experienced candidates may take on Project Leader responsibilities that will require to handle more than 1 study simultaneously. Candidates must demonstrate their abilities in their training, experience and publications. Candidates with GLP experience will be considered first. However, candidates with drug discovery experience will be considered only if their LC/MS/MS or bioanalytical method experiences stand out.
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COMPLIANCE OFFICER Assure that standard operating procedures accurately reflect the functions they address. Internally coordinate and perform audits of the manufacturing process and evaluate adherence to the cGMPs and SOPs. Perform trend investigations and assist in implementing corrective actions. Assist in Regulatory reviews. Assist in the preparation of FDA inspections. Conduct external and internal vendor audits. Qualified candidates need 2-5 yrs. industry experience in the Compliance area within the pharmaceutical industry. Salary to 60k. The client is a major Pharmaceutical Company located in the NJ area.
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MANAGER, STABILITY
Type and Amount of Experience Required:
Justification for Position: |
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