Senior MSAT Engineer | Durham, North Carolina
Position Overview
The Senior MSAT Engineer will support the development and execution of product lifecycle management and process analytics activities with limited supervision and guidance. This role will collaborate effectively with personnel in Process Development, Manufacturing, Engineering, Quality Assurance, and Quality Control and utilize strong communication, technical expertise and influencing skills to generate optimal results.
Major Responsibilities
- Proactively identifies, initiates and executes process and procedural changes to improve business process performance, bioprocessing process robustness, productivity, safety and efficiency, while working with Bioprocessing, Process Development and Quality groups. The position is accountable for evaluating impacts of proposed changes on product quality and regulatory
- Provides guidance and is accountable for determining the root causes of process related deviations in a timely and conclusive manner. This position leads comprehensive data analysis of process statistics, identifies process deviations, assesses product impact, prepares technical reports and proposes comprehensive process solutions and improvements
- Ensures deep understanding of standards of practice, process science and departmental policies through participation in training and development opportunities
- Provides comprehensive training and guidance to operations staff
- Serves as the process expert in HAV production systems; able to fully understand the manufacturing process, automation and engineering controls, to proactively consider solutions to potential problems
- Lead efforts in troubleshooting manufacturing processes that become out-of-trend, providing the intellectual, scientific and engineering leadership to identify and implement scientific, engineering and technical solutions using the change control system
- Investigate, identify root cause, and identify CAPA for bioprocessing deviations
- Trend process performance. Establish data analytics to serve as metrics, to assist in investigations, and as feedback to Process Development for scale up / process transfer
- Author technical reports and protocols in support of cGMP activities
- Partner with Process Development to ensure successful process transfer
- Assist in equipment selection, qualification, and start up activities. Work with Bioprocessing to ensure robust procedures are utilized for operation of equipment
- Develop and execute test protocols, vendor site visits, FAT/SAT, etc.
- Perform hands-on testing/troubleshooting and become the internal process expert
- Work with Process Development, Manufacturing, and Quality Assurance to develop and execute validation strategies, protocols and reports, to satisfy regulatory requirements
- Work with Quality Control and Quality Assurance, to create sampling protocols and assist in selection of monitoring assays
- Identify continuous improvement opportunities in terms of cost savings, process robustness, and manufacturing efficiency gains
- Identify areas where process development is needed and collaborate with the Process Development team to ensure those needs are addressed
- Support regulatory filings
- Other duties, as assigned
Specific Skill Requirements
- Deep and demonstrated knowledge of cGMPs and experience providing technical expertise in a cGMP bioprocessing environment
- Strong operating knowledge of technical and engineering operations of scaled cell culture systems
- Strong operating knowledge of feedback control and monitoring of relevant process gasses, nutrients, biological waste products in mammalian cell systems - Understanding and technical competence with: Masstransferandgastransfercharacteristics - Fluid handling/mechanics - Asepticmanufacturing
- Demonstrated skills in a broad spectrum of bioprocess applications, in-direct leadership, and mentoring of staff
- Demonstrated ability to work effectively within a team to set goals, develop sound project plans, monitor progress, and report results scientifically
- Routinely communicate findings and information to other team members; transparency and knowledge sharing is expected and practiced
- Works as a team player, and serves as a model by participating in activities that involve cooperating with others
Experience Requirements
- BS degree in relevant discipline
- At least 10 years of relevant pharma or biotech industry experience, minimum 3 years GMP experience
- Background in chemical engineering, biochemical engineering, biotechnology, bioprocess, cell technology, biomedical engineering, cell therapy, tissue engineering, regenerative medicine, process development, and/or cell biology
- Possess a demonstrated technical foundation of cell- and tissue- based products and a familiarity with GMP manufacturing
- Highly motivated and organized
- Works and leads well in a team environment
- Strong experience working cross functionally within a BioPharma Bioprocessing organization
- Experience leading projects related to bioprocessing deviations, change control, process optimization, technical troubleshooting, and bioprocessing process changes
- Experience with cell culture operations, specifically using adherent mammalian cells
- Strong Scientific and Engineering technical experience performing cell culture based bioprocessing activities involving vial thaw, inoculum, media development, media optimization, cell line development, and single use bioprocessing technologies