Additional Locations: Purpose and Passion • Comprehensive Benefits • Life-Work Integration • Community • Career Growth At Boston Scientific, you will find a collaborative culture driven by a passion for innovation that keeps us connected on the most essential level. With determination, imagination and a deep caring for human life, we're solving some of the most important healthcare industry challenges. Together, we're one global team committed to making a difference in people's lives around the world. This is a place where you can find a career with meaningful purpose—improving lives through your life's work. Purpose Oversee the day to day operation of the laboratory. Schedule testing and analysts. Carry out testing as required. Provide the first point of contact for analysts on technical issues; Stability coordination provision of a single point person for all storage and testing of the stability finished product and raw material batches, both at BSC and contract laboratories; Conduct analytical testing on commercial, stability and non-routine samples, in addition to participate in the test method development, validation and technical transfers; Provide support and guidance in the areas of cGMP, Regulatory, Technical Investigations, trouble shooting and training. Responsibilities Primary commitment to patient safety and product quality. Understands and comply with all the regulations governing the quality systems. Delivery of key Quality and Performance Objectives. Maintenance of laboratory scorecards and trackers. Review and approval of Laboratory results and documentation, as required the trending and charting of data. Create, review, approve as applicable changes to procedures, controlled documents equipment etc. through Athena, CN, lifecycle process as required. Provide leadership to Technician and Chemist I,II grades. Represent the laboratory on cross functional project teams as required. Attend and represent the laboratories at meetings and communicate information back to management. Conduct OOS investigations, utilizing technical knowledge to identify assignable cause and actions to be taken. Conduct OOS investigations, utilizing technical knowledge to identify assignable cause and actions to be taken. Deputise for the Laboratory Principal Scientisit/ Laboratory Manager as required. Lead LBP/VIP and Continuous project teams as required. May have Supervisory Responsibilities the following additional responsibilities are applicable: Supervising and exercising functional control of the laboratory such that a compliant, cost effective and efficient service is provided; Oversee Day to Day Operations/ scheduling within the laboratory; Participate in the recruitment of laboratory staff in conjunction with human resources; Conduct performance reviews of direct report in conjunction with laboratory management. If Stability Coordination responsibilities the following additional responsibilities are applicable: Liaise with stability study owners on Stability monitoring/ Schedules/ Testing and results; Coordination of contract laboratories in relation to storage/ testing including all test and storage investigations and review of same; Review stability data generated; Coordinate testing with operations analytical laboratory; Maintenance of stability calendar/ trackers and trending. Perform and assist with additional duties as may be directed by laboratory management. Management Requirements BS and 6 years of related experience. Chemist licensed preferably. Minimum of 3 years experience in stability program coordination and interpretation of stability data. Knowledge of current GMP regulations and ICH guidelines for the stability area is a must. Excellent Spanish/English writing and verbal skills. Detail oriented. Understanding scientific data and its interpretation is a must in order to discern trends and make calls about products stability/shelf life. Must be able to troubleshoot and work out problems in testing such as comparison of methods, out of specification results and out of trend data. Experience with database programs such as SLIM, LIMS, Empower etc. Understanding laboratory concept and testing mothodologies is critical. Fully Bilingual Job Scope and Leveling Guidelines Knowledge: A seasoned, experienced professional with a complete understanding and wide application of principle, theories, and concepts in the field. Applies a full understanding of area of specialization to resolve a wide range of issues in creative ways. General knowledge of other related disciplines, business unit function and cross group dependencies/relationships. This job is the fully-qualified career-oriented position. Problem Solving: Develops solutions to a variety of complex problems of diverse scope and complexity where analysis of data requires evaluation of identifiable factors. Exercises authority and judgment within generally defined practices and policies in selecting methods and for Has About us As a global medical technology leader for more than 35 years, our mission at Boston Scientific (NYSE: BSX) is to transform lives through innovative medical solutions that improve the health of patients. If you're looking to truly make a difference to people both around the world and around the corner, there's no better place to make it happen. Boston Scientific is an Equal Opportunity Employer – Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Disability, Veteran Requisition ID: 447464 SDL2017
