Manager GMP Formulation & Filling / 07-4691

Sanofi Pasteur in the USA is a leader in the research, development, manufacture, marketing and sales of vaccines and immunological products because here we clearly see a better tomorrow for all mankind.We have a wide range of vaccines that protect against 20 diseases, but we believe there is still much work to be done. On every continent there exists viruses and bacteria, and we won’t rest until they are eradicated and all people can live healthy, full lives. We’re confident we can achieve our goals. As a subsidiary of Sanofi Aventis, the global pharmaceutical corporation, we have access to the resources needed to continue our boundary-breaking innovations far into the future.Our US site is located in Swiftwater, Pennsylvania, among the scenic Pocono Mountains, sanofi pasteur is housed in state-of-the-art facilities on a 269-acre campus. It is here that our multidisciplinary teams of 1900+ professionals work together to develop and provide new and improved immunological products. Our company is comprised of three global functions: Research & Development, Industrial Operations, and Commercial Operations, as well as seven support functions: Communications, Corporate Development, Finance and Purchasing, Human Resources, Information Solutions, Legal and Corporate Affairs, and Public Policy.For those who wish to make a difference in the world by aiding in the development, production or marketing of vaccines that are critically important to public health, sanofi pasteur offers superb opportunities. Our modern research, production and administrative facility attracts exceptional talent from businesses and universities around the world. Our location offers our people the best of outdoor living close to the cultural, culinary and recreational attractions of Philadelphia and New York City.sanofi pasteur US is a place for those who desire a challenging and rewarding career without compromising their quality of life. If you have the passion, desire, ambition, vision and talent we’re looking for, we invite you to explore our opportunities and to apply online at: www.sanofipasteur.us

Position Description:

Leads, motivates, and develops an expert team of employees who are responsible for formulation and filling of numerous NV vaccines from all three sites.Coordination of the manufacturing process from formulation to final container in either vial or syringe to include: scheduling, document preparation, QA review and sign-off. Responsible for managing timelines as outlined for the PKMs in-place for the projects. Coordination with various other departments such as BSA, AS&AD, QC, RA, QA etc to make clinical production transparent and meet the Class A Quality standards. All of the GMP documents generated during clinical manufacturing must be prepared, executed, and reviewed to the best quality standards to reduce rework and speed the manufacturing process.Manage daily operation of formulation and filling suites to include conflict resolution, scheduling, and training. Establish and maintain networks within the company to facilitate these tasks.Training of personnel for GMP compliance is required to insure all scientists, technicians and operators understand the procedures that they will be employing to make product and that all GMP regulations for clinical manufacturing are satisfied.Works to foster efficient interfaces among departments and projects and the smooth transfer of information and technology. Represents the platform on project teams, providing scientific expertise and organizational expertise.Functions as an internal authority in area of expertise. Participates on committees and technical groups to provide scientific advice. Furnishes technical advice for projects. Participates in external scientific meetings and reads the literature to remain abreast of trends and scientific and technological developments in the field. Prepares scientific reports, contributes to the preparation of regulatory documents.We are an equal opportunity employer M/F/D/V.

Qualifications:

BA/BS or MS in Biology, or related discipline is required along with appropriate experience in formulation and filling of clinical vaccines. Incumbent must have in depth research and development experience including 5-10 years of pharmaceutical experience in product processing, clinical materials manufacturing to include aseptic processing, vial and syringe filling, lyophilization, and GMP compliance. Experience preparing, reviewing and modifying batch production records, deviation investigations, SOPs and maintaining records for labeling/packaging. Proven track record for teamwork and networking within sanofi pasteur and external contacts, as well as leadership and interpersonal skills.