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Full-timeDescriptionSUMMARY It is the primary responsibility of the Senior Engineer, Manufacturing Science and Technology (MSAT) to lead and enable MSAT development as the Subject Matter Expert (SME) for the Company’s existing and developing product portfolio. The senior engineer is responsible for all MSAT functions in support of cGMP drug substance manufacturing, including transferring, monitoring, troubleshooting, and improving drug substance production processes and technologies. This individual will be self-motivated, detail-oriented, productive in team settings, and an effective oral and written communicator across functional areas and technical levels. JOB RESPONSIBILITIESEssential ? Apply advanced engineering principles to the transfer, monitoring, validation, and troubleshooting activities of drug substance manufacturing processes. ? Partner with cross functional teams at decision level including Process Development, Quality,Supply Chain Management, Drug Product Manufacturing, and Engineering.? Drive implementation of new technologies to improve manufacturing efficiency and ease of operations.? Plan and implement long range technology programs.
Propose, design, and implement advanced major scientific experiments which contribute to the overall program objectives and extend the boundary of knowledge in their field.? Develop the MSAT team through:
- motivate employees, provide coaching and feedback for individual career growth and development;
- recognize and appreciate employee contributions;
- mitigate conflict and communication problems;
- plan and facilitate team activities;
- provide training and emphasize best practices;
Supplemental Responsibilities? Evaluate and/or test the feasibility of new manufacturing processes, materials, and technologies? Lead collection and statistical analysis of manufacturing in-process control and process parameter data to trend process performance, generate campaign summary report as needed.? Lead process-related deviation investigations, assess impact to product quality, identify root cause and propose corrective and preventative actions. ? Implement new equipment and process technologies in the manufacturing area and train manufacturing personnel on these technologies; serve as a technical resource on equipment capabilities and troubleshooting.? Initiate and recommend improvements in process and equipment operation, based on sound engineering and scientific knowledge, toward increasing process robustness, efficiency, and productivity.? Author SOPs and batch records for new process and new technology as needed.? Contribute to regulatory filings and inspections.? Collaborate in cross functional activities with development and manufacturing personnel, both internal and external, to support process scale-up, technology transfer, process characterization, and process validation. ? Provide process and technical support on the manufacturing floor.? Provide training and guidance on process and technical operations to manufacturing personnel recommend and present disciplinary actions to subordinates when required.RequirementsJOB REQUIREMENTSEducation? Bachelor’s or advanced degree in chemical/biochemical engineering, chemistry/biochemistry, biological sciences, or related disciplines. ? BS with 10 years of relevant experience, with 3 years of direct MSAT experience; or MS with 8 years of relevant experience, with 3 years of direct MSAT experience; or PhD with 3 years of relevant experience in biopharmaceutical research and manufacturing settings and 3 years of direct MSAT experience. Knowledge, skills, and abilities? Advanced experience with biopharmaceutical manufacturing process and equipment. ? Extensive knowledge of cGMP regulations/guidance and quality systems. ? Must have an understanding of statistical methods and their application in technology transfer and product lifecycle.? Ability to inspire and foster innovation, collaboration, transparency and team effectiveness.? Proficiency with MS Word, Excel, and PowerPoint. ? Familiarity with statistical software, such as JMP, is desirable. ? Excellent interpersonal, verbal and written communication skills as well as digital literacy? Ability to function efficiently and independently in a changing environment? Proactive and willing to accept temporary responsibilities outside of initial job descriptionSalary Description105,400 - 124,000
