Process Development Scientist
QC Senior Analyst
SRG offers flexible staffing solutions with a national presence. We provide contract, contract-to-hire, direct hire and executive search services. SRG utilizes an innovative approach to identify and qualify talent that is unique to the Staffing industry, featuring a cutting-edge platform that allows us to rapidly and precisely match professionals to client requirements. We have a proprietary database of over one million candidates and maintain continuous contact with our qualified talent.
Title: QC Senior Analyst
Location: Houston, TX
Hours: Monday-Friday; 8:00 am 5:00 pm
Salary: $42hr based on experience
Employment Type: Long Term Contract to Hire
Environment: A global leader and trusted supplier in the pharma, biotech and specialty ingredients markets. Headquartered in Basel, Switzerland, the company is focused on advanced manufacturing, high-quality control systems, regulatory expertise, and research and development (R&D) capabilities. The company s products and services include active pharmaceutical ingredients (API), stem cell therapies, drinking water sanitizers, vitamin B compounds, organic personal care ingredients, industrial preservatives and microbial control solution to combat viruses, bacteria and other dangerous pathogens.
- The MSAT Senior Scientist will be responsible for the successful transfer of viral vector and/or viral cell therapy processes into GMP production. The incumbent will collaborate with cross-functional teams, including Lonza s client, Process Development, Manufacturing, and Program Management to ensure on time delivery of batch records.
- MSAT Senior Scientist will act as a technical Subject Matter Expert (SME) within the MSAT group as well as for the various project teams. The incumbent will provide technical support to General Manufacturing Practices (GMP) execution of the new processes and any deviation investigations, Corrective Action Prevention Plans (CAPAs), and necessary change controls. MSAT Sr. Scientists ensure process scalability and manufacturability and will support process validation activities for late phase production. May provide guidance on process transfer and support activities to junior members of the team.
- Functional Lead for Process Technology Transfers. Performance detailed review of clients and Research and Development (R&D) process and generates, in collaboration with R&D, technology transfer documents. Performs Fit/Gap analysis and process Failure Modes and Effects Analysis (FMEA), author / review Process Flow Diagrams and Batch Records, perform process monitoring (manufacturing data summary and analysis, data presentation), author campaign summary reports. Recommends improvements for MSAT practices and procedures.
- Supports root cause analysis for major process deviations. Support CAPA and change control processes
- Management of data and analyzes of various operational parameters.
- Technology transfer activities. The activities include but are not limited to, performing process fit-to-plant, equipment characterization and scale-up, Failure Modes and Effects Analysis (FMEA)-based risk assessment, creation of Bill of Materials, review and approval of production Master Batch Records.
- Bachelor s Degree required in a field of study such as Chemical Engineering, Biochemical Engineering, Biomedical Engineering, Biotechnology, or other life science degrees.
- Master of Science degree preferred or PhD in Engineering and/or sciences preferred.
- Substantial experience with Biologics process development, MSAT or Manufacturing.
- Substantial experience with CMC regulations, and international guidelines including but not limited to Federal Drug Administration (FDA)
- Knowledge of cell biology, adherent and suspension cell culture, scale-up and bioreactor operation, chromatography operation, Ultrafiltration/Diafiltration (UF/DF), Tangential Flow Filtration (TFF), and aseptic filling.
- Work experience in cell therapy product/process development or manufacturing is a plus.