Designs and implements business processes to enable product research and development portfolio prioritization, resource allocation, and risk management. Designs related integrated process and product team activities and directs technical and operational activities to ensure vertical and horizontal integration. Provides product portfolio analyses and reports to management committees for support of decision-making. Leads teams in strategy efforts, lifecycle management planning, and assessments of probability-of-success. Develops systems to support dynamic portfolio management. Serves a key role in portfolio evaluation process. Drives initiatives across functions, research and development units to create fully integrated strategies. Monitors and reports on portfolio status and proactively addresses and resolves issues.
Be the technical expert in support of Research and Development and Manufacturing Operations to ensure the manufacturing processes are capable, compliant, in control and continuously improved.
· Role that this position reports to: Manager, R&D Manufacturing Support
· Role(s) that report to this position: N/A
Main Responsibilities and Accountabilities:
•Assist with manufacturing support projects, which include the execution of laboratory experimentation, and the analysis/dissemination of technical information necessary to manufacture plasma-derived products.
•Provide technical support to Quality Operations regarding deviation investigation, process validation, change management/control, material change control, and CAPAs.
•Anticipate potential problems and design preventative solutions. Maintain an awareness of production processes and their interdependencies, and be proactive in introducing improvements in yield or quality. Provide floor support to Manufacturing and daily guidance for manufacturing projects whenever necessary.
•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, technology transfer, manufacturing improvement, and deviation investigation.
•Coordinate scientific and investigative studies through collaboration with internal customers, academic research organizations, contract laboratories, etc., and think creatively and provide technical justification for novel concepts and approaches.
•Perform fundamental literature and patent searches related to activities and develop alternative strategies, if necessary.
•Maintain an awareness of and compliance with current Good Manufacturing Procedures.
Qualifications and Experience Requirements:
Education: Minimum BS/BA in Biochemistry, Biochemical Engineering, Biotechnology, or related fields and relevant experience in these fields.
Experience: Knowledge of and familiarity with GMP Manufacturing for large molecules, preferably with Plasma Fractionation, in a scientific technical support role. Understanding of protein purification process, protein stability, and other related biochemical concepts.
Authoring of scientific technical reports for the support of deviation management or process improvement proposals. Familiarity with ICH Q8, Q9, Q10.
Strong scientific technical writing
Strong problem solving skills
PC literate with word processing, spreadsheet, and database application skill set ( Excel, Minitab, Design Expert, or other statistical program). A good practical knowledge of cGMPs. Basic functional/technical and problem solving skills. Basic time management and use of organization skills and procedures. Proficient verbal , and written communication skills. Interpersonal savvy.
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