Description:
Associate Manufacturing Technical Specialist
Summary
Responsible for providing scientific and technical support to GMP Manufacturing Operations in a multi-product, large scale, automated biopharmaceutical facility. This includes activities related to safety, compliance, quality, targeted innovation, and plant performance and success. Deliverables include but are not limited to implementation of targeted new technologies and procedures, assessing, evaluating and providing immediate corrective actions for GMP discrepancies and intra batch process monitoring, analysis and reporting. May troubleshoot equipment, systems, and process; develop new equipment requirements and operating parameters, providing factory acceptance testing and validation support. Investigates operational and process discrepancies, implements corrective action, and develops and validates manufacturing improvements. Perform required operations and studies at pilot and small scale to support make-assess-release, technology transfers, and technology road map by taking active part in data analysis.
Job Responsibilities
- Lead PV sampling activities during tech transfers to Oceanside (main job responsibility):
-Manage PV sample request system; ensure all samples required for PV are added to tracking system
-Develop sampling schedule; allocate personnel needed for sampling duties, and execute sample aliquoting/freezing operations within the sample-to-freeze timelines captured in the NRS gDoc
-Secure all required PV sampling containers and provide to Manufacturing
-Aliquot, label and freeze PV samples within specified hold time
-Create appropriate sample chain of custody documentation and procedures to comply with regulatory requirements
-Coordinate with testing labs for sample test submissions; provide testing forecast to labs, as needed
-Coordinate with OCN Materials Management and receiving labs to ship samples for testing per the scheduled ship dates
-Facilitate the transfer of analytical data to study authors
-Provide weekly updates to PV subteams
-Be an integral member of the Oceanside Laboratory and Pilot Plant (OLP) team:
-Perform required operations at pilot and small scale
-Execute and lead small/pilot scale studies in close collaboration with customer and all involved groups to support: make-assess release, tech transfers, and network.
-Automation and Engineering Solutions and act as a member of a high functioning team. These tasks will include those associated with coordinating and performing operations (i.e. set up, inoculating, maintaining, harvesting and cleaning equipment/bioreactors)
-Experiment data recording, collection, and analysis. He/she should be able to present information timely, clearly, and confidently.
-Support technical transfers of phase III molecules from late stage process development to commercial launch scale and commercial scale to commercial scale: verification of scale-down model and site dependent/facility fit studies.
-Support close communication between late stage process development and molecule recipient commercial site.
-Assist technical teams in support of site investigations and commercial make-assess-release.
Support scale-up of processes:
o Ability to generate feedstock for downstream pilot-scale studies
o Harvest process parameter range studies (pilot scale)
o Characterization at pilot scale to ensure optimal operability at large scale: consistency runs (thaw to formulation) and verification of manufacturing process robustness at pilot scale.
Liaison between Operations and the Pilot Plant customers.
-Offer technical/operational expertise, attentive customer service, and work as an integral partner in the successful execution of experiments.
-Provide and spearhead troubleshooting assistance with equipment and processes
-Trainer for other technicians and support personnel.
-Specific focus on continuous process improvement, new technology/process implementation and will design experiments and apply theories to execute projects.
-Support independent projects as well as participate on cross-functional teams as a representative of the laboratory and pilot plant.
-All employees with jobs that require access to the Warehouse must be able to pass the Transportation Security Administration (TSA) Security Threat Assessment (STA)
-Ensures the integration of environmental health, safety, and security into the business processes, systems, and programs while reporting safety and environmental incidents including injuries, illnesses, and safety suggestions within ones functional area. Fosters a positive safety culture in which no one gets hurt.
Requirements:
-The ability to work independently under limited supervision
-Coordinating and performing operations and tasks associated with cell culture experiments at pilot and small scale.
-Having a solid understanding about CHO processes and experience with analytical instruments is preferred.
-The ability to display a strong focus on collaboration, customer service, attention to detail, analytical ability and intellectual curiosity.
-Must be able to work on a team with diverse skills and objectives and interact with customers in a productive manner.
-Operational and technical troubleshooting skills and creative, flexible problem solving skills are required.
-Project coordination/management skills are needed and must have demonstrated the ability to take a project from idea inception to implementation.
-Interfacing with customer groups by seeking opportunities for collaboration, and proactively communicating and presenting information timely, clearly, confidently, and concisely and offer relevant views and information to impact decisions.
-High level of demonstrated initiative, exhibit flexibility in work approach, and demonstrate strong follow through and accountability.
-Must be self-driven to learn and keep current with new technology developments and be organized and capable of multitasking, have effective problem solving abilities, and have demonstrated reliable decision-making.
-Demonstrates flexibility to ensure that all cell culture operations at pilot and small scale are supported to meet run schedule demands while managing other areas of responsibility, such as project support.
-Mechanical aptitude and knowledge and experience with computer systems are also needed.
Education
Bachelor's degree in Chemical/Biochemical Engineering or Life Sciences.
Must have 0 - 3 years of hands-on cell culture experience and a familiarity with pilot plant and lab techniques and processing.
EEO Statement Apollo Professional Solutions, Inc. is an equal opportunity employer. We provide equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, marital status, age, national origin, ancestry, disability status, medical condition, pregnancy, genetic information, protected veteran status, gender, sexual orientation, gender identity or expression, or any other status or characteristic protected under federal, state, or local law.
