Assumes leadership role to investigates, analyze, and assesses product impact on manufacturing and supply chain deviations. As scientific technical expert of product family, leads and supports process optimization changes that would drive towards increased cost efficiency andpatient safety.
Main Responsibilities and Accountabilities:
1. Under minimal supervision, lead or participate in cross-departmental teams in support of deviation investigation, change control, and CAPAs to develop feasible solutions and timelines. Represent R&D in such teams as subject matter expert for product line.
2. Provide floor support to Manufacturing for real-time deviations and independently provide guidance to minimize product quality impact.
3. Independently and proficiently propose, design, and lead manufacturing support projects, which could include execution of laboratory experimentation, and the analysis and dissemination of technical information necessary to manufacture plasma-derived products. Could include supervision and coaching of junior staff in support of execution.
4. Anticipate potential problems and independently design and propose preventative solutions to R&D and site Management. Maintain awareness of production processes and their interdependencies, and be proactive in introducing improvements in yield or quality.
5. Maintain an appropriate level of documentation and communication through timely and thorough drafting and execution of protocols and reports in support of R&D process development or operations support.
Maintain an awareness of and compliance with current Good
6. Manufacturing Practices and Good Laboratory Practices.
7. Completes any other duties/responsibilitiesassigned by management.
Manager, Operations Support
Key relationships to this position:
Quality Assurance, Manufacturing, Global R&D
Position Qualifications and Experience Requirements:
BS/BA, MS, Ph.D. in science-related fields such as Chemistry, Biochemistry, Bioprocess Engineering
6-10 years’ experience with proven leadership roles in deviation troubleshooting and/or process improvement projects in large scale manufacturing
Preferred: Knowledge and familiarity of protein chemistry and protein purification techniques (column chromatography, resin adsorption, TFF)