Senior Process Scientist - Technology Transfer, Commercial Operations Support
About the Job
Responsible for providing technical support, process improvement, and process transfer activities as assigned by Manufacturing Technology leadership. Ensure processes are appropriately controlled and executed per process descriptions described in CMC documentation. Provide technical support to the day to day manufacturing operations for products manufactured at the Manatí Parenteral Manufacturing Facility. The support includes the processes, formulation and equipment used in the manufacture of parenteral and/or biological drug products such as sterile filtration, aseptic filling, lyophilization, capping and visual inspection among other key supporting unit operations. Performs protocols and studies in support of new products from Research and Development or existing products from other BMS sites or business partners to satisfy business needs. This position must comply with all Security guidelines, Environmental Health and Safety regulations and the current Good Manufacturing Practices. Supports pharmaceutical process activities to achieve a successful on time resolution of incidents and deviations and enhances quality and effectiveness of manufacturing systems including change control and CAPA actions towards optimization manufacturing processes to assure effectiveness, robustness, and compliance. Monitors the commercial processes to ensure material inputs, process equipment, procedures, and controls to continually deliver product meeting specifications including periodic monitoring of on the floor activities. Performs process FMEA’s and other process verification activities per current Regulatory Guidelines with process validation. Leads and authors complex process-related investigations for the supported products and supports investigations lead by others (by providing clearly documented technical memos). Partners with automation, manufacturing, and Information Management to ensure manufacturing processes are appropriately described in the Manufacturing Batch Record, (whether manual or electronic) per process description (as outlined in CMC documentation) and; escalates to site leadership when gaps in process capability are identified. Writes strong technical documents related to Manufacturing and Quality Support (i.e. QEs, discrepancies and support to complaint investigations), Process Optimization (i.e. DOE ‘s), and other technical protocols to support the process (which may include Aseptic Processing Validation (Media Fills), Process Validation, Experimental protocols) and, other Technology Transfer activities. Supports the technical related aspects of the manufacturing processes (i.e. investigations, complaints evaluation, change controls). Performs process justification, LTSS, and validation protocols in support of manufacturing processes within established timelines and with the required level of robustness and quality expectations. These activities may be driven by change control on an existing product, or an element of technical transfer plan. Performs the transfer and start-up of new and existing products to be manufactured, through plant trial runs and/or stability lots, guaranteeing implementation of a feasible and efficient process. Supports the design, execution and evaluation of process validation and process justification protocols to ascertain the required process capabilities, specifications and robustness including the authoring of high quality technical reports requiring minimal review. Provides timely and efficient technical support to qualified/validated systems/processes/products and writes comprehensive technical reports to document all process improvement or investigation projects. Designs, develops and conducts process studies/projects aimed at process optimization to improve efficiency and reduce operating costs and; recommends, propose and formalize alternatives for the optimization of validated or new processes. Plans and coordinates new and ongoing projects to assure successful and timely execution issuing and updating detailed time and event schedules. Performs raw material characterization studies to support vendor qualification programs and to offer source alternatives. Defends current process technology (as employed) with Global Health Authorities. Performs pharmaceutical troubleshooting to solve process related problems during production to determine the required steps to correctly resume production, while guaranteeing compliance with the process (as described in the batch record and CMC documentation). Evaluates and appraises Process/Equipment changes in regards to regulatory requirements. Assess products/processes performance for new or existing products utilizing statistical tools and other techniques. Trains professionals and pharmaceutical operators on the processing technology for existing and/or new products and generate training documentation.Qualification: Bachelor’s Degree in Pharmacy, Chemistry or Chemical/Mechanical Engineering or any other related Science field. Five (5) years of experience in pharmaceutical manufacturing processes, technologies and aseptic processing equipment for parenteral and biological dosage forms. Three (3) years of experience in pharmaceutical technology transfer, process improvements and troubleshooting. Proficient knowledge of biopharmaceutical formulation processes, parenteral filling, lyophilization and syringe filling processes. Proficient knowledge of product and process development, manufacturing scale up, continuous process improvement and troubleshooting processes in conformance with departmental standards and in compliance with regulations. Detailed understanding of how parenteral manufacturing process are controlled and validated. Ability to effectively manage multiple projects at the same time with minimum supervision and to incorporate a wide array of technical principles, concepts and theories in innovative ways to technology transfer and scale-up activities. Strong project management skills. Proficient time management skills, planning and organization capabilities. Proven ability to influence and work with people at different levels and departments. Proven leadership & teamwork skills, self-starter, results oriented and build and maintain strong relationships with multiple groups. Proficient in Statistical Process Control, Process Capability and Risk Assessment/Management. Proven assessment, analytical and problem-solving skills. Proficient presentation skills and Technical Writing/Oral communication skills (English/Spanish). Proficient in cGMP's, OSHA and FDA Regulations as it applies to pharmaceutical industry. Willing to work irregular hours, rotating shifts, weekends and holidays.