Manager, Pharmaceutical Development / 74

Position Description:Since its founding in 1839, B. Braun has built an unparalleled store of knowledge and expertise in delivering innovative healthcare products, medical devices and programs that enhance working processes in hospitals, alternate care settings and medical practices – increasing safety for patients, doctors and nurses. Its 34,000 employees worldwide are proud of their commitment to translating customer needs into products with unmatched quality, superior technology, cost-effectiveness and environmental responsibility.We are currently seeking a Pharmaceutical Development Manager.ESSENTIAL FUNCTIONS: Acts as Team Leader to 1-6 direct reports supervising all activities associated with Methods Development, Methods validation, Formulation Development, Raw Material Qualification, and New Product Feasibility Study and delivering the results within the defined time deadlines. Works with other Team Leaders to establish short-term and long-term objectives in Pharmaceutical Development to develop new IV products. Reviews work, results, data, reports and any other documents generated by others for compliance to current requirements of B. Braun and appropriate outside regulatory authorities.Supervises and works with direct reports and others on a daily basis to solve technical problems in areas of chromatography, mass spectroscopy, other analytical techniques, and pharmaceutical development related issues.Works with Lab Manager to ensure that daily laboratory operation is in compliance with all related requirements from B.Braun and appropriate outside regulatory authorities, particularly the cGMP requirement.Defines, prepares, and executes technical protocols in support of raw materials, finished products, process and methods utilizing both internal and external resources.Makes recommendations for new products and technologies for R&D evaluation.Authors study protocols, reports and any other related documents.Assists in writing the CMC for regulatory submissions, interaction with FDA center and local districts.Participates in budget and capital planning. Reviews and/or develops specifications for new components and products for suitability with manufacturing systems.To qualify for this position, candidates must possess:QUALIFICATIONS GUIDELINES: Ph.D in Chemistry or related fields with more than 10 years of pharmaceutical experience or MS/BS with over 15 years of pharmaceutical industry experience.Demonstrated in-depth understanding of chromatography, mass spectroscopy, other analytical techniques and pharmaceutical development related requirements. Strong knowledge of GMPs, GLPs, and environmental regulations.Excellent written and verbal English skills.Proven good organizational / leadership skills.Good communication and interpersonal skills.B. Braun offers an excellent benefits package, which includes healthcare, a 401(k) plan, company sponsored pension, and tuition reimbursement. To learn more about B. Braun and our safety healthcare products or view a listing of our employment opportunities, please visit us on the internet at www.bbraunusa.com An EOE.