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Group: JOBS 2.0: Job Search Career Networking Staffing. Post Resume -Get Paid by Employers at Resumark .com Subject: Robert Ciociola posted a job: "Job: Process Validation Manager 262 in Lancaster, PA Process Validation Manager -Lancaster,PA Contract Position-29 months Send resumes to: bciociola@covexllc.com In this capacity, the Process Validation Manager will lead product/process remediation activities related to formulation development and process validations, including technology transfers. The primary function of this role is manage a group of skilled professionals, providing technical support (process development, process validation, product and process troubleshooting, process & product optimization, and technical transfer) of commercialized products. This individual determines resource strategy and project criticality to effectively manage the department. This individual will approve reports and confirm conclusions based on scientific rationale. The Process Validation Manager will write or approve SOP's and memos based on area of experience and training. They will also review critical departmental reports such as Development, Validation, and Research Reports. In addition, this individual will review Regulatory documents and provide input as required for NDA's and sNDA submissions. This individual will provide technical input for strategic company guidelines and policies. This individual will partner both intra and interdepartmentally. The Process Validation Manager will also write goals and objectives based on Company goals and objectives. Education: A minimum of a BS is required. An advanced degree is preferred. Experience/Technical Competencies: Candidates must have a minimum of 8 years experience in pharmaceutical solid dose formulation and process development. Experience with laboratory, pilot, commercial scale processing, and technology transfer of products is required. Solid background in the area of product development validation and technology transfer is required. Candidates will be capable of applying diversified expertise in technical principles and practices in pharmaceutics, broad chemistry areas, and/or engineering. Broad (e.g. global) knowledge of the pharmaceutical business is required. Previous experience for interpreting, organizing and coordinating projects is required. Broad knowledge and experience with regulatory requirements including FDA, EMEA, and compendia (e.g. USP, PhEur, JP, etc.) is required. Strong skills in technical troubleshooting are necessary. Excellent knowledge of GMPs, GLPs, ICH, CFR, latest regulatory trends and global regulations are required. Prior experience in leading a group or multiple senior/junior scientists and/or technicians is required. Previous experience developing standards and guidelines for diverse R&D activities is required. Strong interpersonal, written and verbal communication skills are required as is demonstrated leadership skills and ability to work independently as well as in a team environment applying scientific principles. Ability to gather information, analyze, design and implement process change is required. Strong analytical and mechanical aptitude ... http://bull.hn/l/P7KV/2"

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