Engineer Gene Delivery, Pharmaceutical

ENGINEER GENE DELIVERY, PHARMACEUTICAL SEATTLE, WA Seattle, WA / Warren, NJ/ Remote. Project Description:

• Our client is looking for an Engineer to join the Manufacturing Science and Technology Gene Delivery and Editing department.
• The position will be responsible for the routine MSAT support to our US CMO partners.
• This engineer will have responsibilities like an internal MSAT organization for Client's viral vector manufacturing and fill/finish sites with the focus on supplementing the technical capabilities of the CMO and driving continuous improvement.
• This person may be responsible for and support processes including PPQ, commercial launch, and commercial manufacturing support.
• The Candidate will support product lifecycle management, including commercialization and evolution of cell therapy products as well as day to day operations technical support at CMOs to ensure reliable quality supply.
• The role will be highly cross-functional and will interact with other groups and in-country affiliates in establishing manufacturing and technology capability, facility fit, and design, equipment selection, and facility start up work.
• Provide process engineering support to a biopharmaceutical process development organization.
• Develop mathematical models to simulate fermentation and chromatography unit operations.
• Perform experiments to verify accuracy of model.
• Review design documents related to procurement of new equipment.
• Perform testing and operation of bioprocessing equipment; write reports required for tech transfer; evaluate performance of new technologies.
• Provide remote technical troubleshooting support for manufacturing activities at external manufacturing locations and when needed, provide on-site technical process support of ongoing manufacturing processes.
• Create and revise technical documentation (e.g., changes controls, SOPs, and batch records).
• Perform deviation investigations and corrective and preventive actions (CAPA) as a technical resource.
• Author technically challenging deviations and drive them towards closure.
• Provide data collection, interpretation, and analysis on manufacturing and manufacturing support processes.
• Determine areas of opportunity, shifts and trends, and states of control.
• Collaborate with cross-functional teams, including the CMO joint process team, Process Development, Manufacturing, Quality Assurance and External Manufacturing.
• Performing process fit-to-plant, equipment characterization and scale-up, process Failure Modes and Effects Analysis (FMEA)-based risk assessment, creation of Process Flow Diagrams and Bill of Materials, review, and approval of production Master Batch Records.
• Perform detailed review of Process Development processes and generate technology transfer documents, including process monitoring (manufacturing data analysis, summary, and presentation) and authoring campaign summary reports.
• Responsible for the successful transfer of viral vector processes into GMP production.
• Assist with validation and startup activities that may include authoring PPQ protocols and reports, providing process training to support implementation of new technologies and specifications as well as process changes.
• Develop simulated process models to estimate throughput capacity, resources, and inventory levels.

Required Skills:

• MSc or BSc in Chemical Engineering, Biochemical Engineering or equivalent with 10+ years of relevant experience in process development or commercial manufacturing.
• Extensive experience in a regulated GMP manufacturing environment (clinical and/or commercial)
• Demonstrated ability to effectively work in cross functional teams, meet deadlines, and prioritize multiple projects.
• Experience in development and/or characterization of biologics and/or cell therapy manufacturing processes.
• Experience with cGMP, ICH guidelines, PPQ (process validation), and working with a Quality organization.
• Experience working in a self-driven, performance/results oriented, fast paced matrix environment.
• Experience or knowledge of creating computer-based process models using process simulation software.
• Experience or knowledge of statistical analysis using statistical software package.
• Able to creatively manage time and elevate relevant issues to project lead and line management.
• Strong scientific and technical writing.
• Detail oriented with excellent verbal and written communication skills.
• Ability to travel domestically and internationally.
• Must be able to work independently and stay focused on challenging problems.
• Work in the laboratory environment may also be required.
• Experience with Mathcad and process simulation tools is a plus.
• OpEx and Lean Six Sigma project experience is strongly preferred.
• Knowledge of CAR-T and/or lentiviral vector manufacturing a plus.
• Strong analytical and problem-solving skills desired.

This 12+ month position starts ASAP. Please E-MAIL your resume (attachment to email) with rate and availability to Bridget: ALPHA'S REQUIREMENT #22-00967 MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE