Lead MS&T Engineer – New Hampshire
This challenging position for a Process Engineer / Scientist (level to be determined by candidates experience and knowledge in alignment with career matrix) is available in the process transfer and support group of the Manufacturing Sciences and Technology Department (MSAT) in the facility. This position is responsible for being the primary technical support person for Cell Culture operations globally within the corporation. This person has experience with supporting at least one late stage clinical or commercial manufacturing process. The individual will be considered a subject matter expert however it is expected that questions on tasks or issues will be raised by this individual when clarification or greater technical expertise is required. This position will report to MSAT Process Engineering Manager.
- Represents MSAT on project teams as technical lead and interfaces with customer technical and quality representatives.
- Performs most of the functions associated with process transfer and / or process support, e.g. develop process understanding, perform gap analysis / FMEA, generate process models, author / review Process Descriptions and Batch Records, author / review change controls, perform process monitoring (manufacturing data analysis and presentation) and perform process overview trainings to Manufacturing Associates and Production Support departments.
- Provides impact assessment support deviations. Identifies potential root causes with assistance.
- Performs data analysis such as; statistical process control charting and simple linear regression.
- Participates in Customer Audits and Regulatory Agency Audits.
- Biotech industry experience in cell culture process development and process scale up / manufacturing.
- Degree in Biological Sciences, Chemistry or Chemical Engineering and several years of experience
- Experience with large scale manufacturing support (mammalian cell culture preferred), current Good Manufacturing Practices, US / EU regulations.
- Knowledge of cell biology, protein structure, scale up, chromatography, UF/DF, virus filtration and statistical data analysis.
This global organization is one of the world’s leading and most-trusted suppliers to the pharmaceutical, biotech and specialty ingredients markets. They harness science and technology to create products that support safer and healthier living and that enhance the overall quality of life. Not only are they a custom manufacturer and developer, this company also offers services and a wide range of products to include active pharmaceutical ingredients, stem-cell therapies, organic personal care ingredients to agricultural products, and from industrial preservatives to microbial control solutions that combat dangerous viruses, bacteria, and other pathogens. The company invests in quality workforce and the culture encourages the employees to challenge themselves and offer a work environment that fosters creativity and success. They have extensive benefits, competitive compensation, and opportunities for advancement.