Support activities related to the optimization of existing products/processes and implementation of new product launches and process changes to support existing products. Supports the process of exploring and evaluating project feasibility with an emphasis on technology requirements, facility compatibility, and compliance issues. Focus on continuous improvement in terms of process, cost, quality and production of both existing and future product lines. Demonstrates, understands and implementation of Quality by Design in product and process development.
Essential Duties and Responsibilities:
- Designing studies under instruction, executing experiments and data analysis to support GMP investigations, manufacturing change controls and to reduce reoccurring deviations
- Facilitates technology transfer from process development to GMP for new product introductions, exploring modifications of existing processes, execute process development protocols
- Develops process documentation and training materials for new processes, materials, and equipment
- Conducts activities related to the development of new processes, evaluating process cost, quality, and capability alternatives, and performing process under limited supervision
- Functions as a technical role model and resource/consultant to others
- Support of development of new product/processes, continuous improvement, testing, new equipment, new technologies and manufacturing process development.
- Work on multiple concurrent engineering/ R&D projects while ensuring their success in meeting respective objectives and timelines.
- Support continuous improvement projects addressing: process efficiency, product costs and performance
- Support Manufacturing in production troubleshooting and identification of root cause by conducting investigations by providing technical expertise guidance
- Follow project plan, timeline and logistics to support new product/process launches or process changes for existing products
- Participate in supporting transfer of technology to Manufacturing for new products/processes from the development stage to validation with adequate transition plans to transfer knowledge
- Support developmental and transfer activities including: research of new concepts, R&D testing, upstream and downstream process, in-process controls, scale-up, component changes and validation
- Participate in the development and implementation of reliable methods/processes, working across functional groups to implement within the various manufacturing areas
- Develop process/equipment SOPs and associated documents
- Work collaboratively with Validation department to design, conduct, and develop reports for experiments to characterize and validate new or changed manufacturing processes or new equipment/technology
- Support optimization of current processes by improving efficiency, throughput, reduce cost or increasing yield
- Compile and maintain critical data supporting R&D, engineering and validation work
- Bachelor's degree in science required
- 2-4 years of relevant biologics manufacturing experience
- Experience with supporting validation in a GMP environment is preferred
- Strategic expertise with an action oriented perspective, sound problem analysis and logical thinking, with the ability to develop investigational plans
- Utilizes knowledge of engineering, literature, and experience to guide decision for complex situations
- Ability to effectively organize and work in a fast-paced, multitasking, deadline-driven work environment under pressure and with competing demands.
- Ability to lead in a strategic thinking and analytical manner, with a strong ability to translate these and implement operationally.
- Must be self-motivated and possess an independent work style
- Excellent interpersonal skills with the ability to interact professionally and effectively with peers, management, and leadership
- Excellent written and verbal communication, problem solving and organizational skills.
- Adaptable to changes in the work environment
This position works in a standard lab setting and may come in contact with various solutions and chemicals, and will be responsible for biological processes such as bacterial growth.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
While performing the duties of this job, the employee is regularly required to talk, see or hear. The employee frequently is required to stand; walk; bend; lift up to 50 pounds; use hands to finger, handle or feel; and reach with hands and arms.
Aldevron is a custom manufacturing organization that provides plasmid, protein and antibody development and production services. Headquartered in Fargo, ND with locations in Madison, WI and Freiburg, Germany we constantly look to innovate and advance life science through collaborative partnerships. Aldevron works with leaders in pharmaceutical, biotech and research institutions around the world to accelerate the development of drug, treatment and preventions for numerous diseases and genetic disorders. Our reputation for innovative solutions for our clients has allowed us to expand our organization and offerings in all service platforms. We are working in a landmark moment in the history of life science.