Staff Scientist

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Job description

Job Description

Job Description:

• This growth role is available in Manufacturing Science & Technologys (MSATs) Process Validation department at client
• Qualified individuals will lead process validation activities for customer programs and will be responsible for planning and executing process validation studies in support of PPQ batches and commercial process optimizations.
• This role will be primarily responsible for authoring process validation protocols, overseeing study execution, analyzing the findings, and creating written reports summarizing the findings.
• This role will require cross-functional work with QA, operations, quality control and process engineering to ensure validation studies are performed appropriately according to site policies and regulations.
• This person has developed a core competency in process validation and has some experience with either upstream (cell culture) or downstream (protein purification) processes as well as experience working with single-use technology.

Key Responsibilities:

• Provide technical direction to core teams and act as customer-facing lead for project teams
• Manage the scope, schedule, and reporting of PV program activities for individual products and/or clients; ensure status, risks, and open issues are tracked and that all stakeholders are informed of changes.
• Design PV studies to meet the stated intent including development of acceptance criteria.
• Author and review PV Plans and protocols.
• Review data to ensure accuracy and completeness. Effectively trend and chart data for process validation reports.
• Author and perform the technical review of deviations and change controls related to commercial manufacturing.
• Make recommendations for process optimization and sponsors these to the larger process team.
• Identify potential root causes of variation and deviations using a systematic approach. Expertise in use / application of variety of problem-solving tools e.g. Ishikawa, Kepner-Tregoe (KT), five-whys, etc. Resolve complex problems and lead multidisciplinary teams in developing and implementing solutions.
• Collaborate with global PV team to drive strategy alignment across the greater network.
• Coach junior staff and drive to best practices.

Competencies:

• Demonstrate highly effective oral and written communication skills and possess management skills including the ability to engage the organization at multiple levels.
• Depth of experience writing technical reports/protocols.
• Knowledge of intermediate to advanced statistical analyses such as T-tests, F-tests, box-plots, understanding p values, etc. as well as control charting, Nelsons/Shewarts rules (or other statistical trending rules), etc.
• Advanced knowledge of mainstream statistical software analysis program such as SAS, MiniTab, JMP as well as an intermediate knowledge of process validation principles and their application in biologics drug substance manufacturing.
• Build productive customer and internal relationships to foster collaboration and continued process improvement
• Strong organizational skills, able to define and delineate roles and tasks, ability to forward plan.
• Seeks opportunities to improve and extend their contributions outside of their daily work.

Minimum Requirements/Qualifications:

• 6+ years of process validation experience or experience in fields related to biologics drug manufacturing.
• Commercial scale manufacturing experience is required.
• Diverse knowledge and experience in relevant areas is preferred.
• Strong understanding of current global regulations related to process validation and understanding of the applications.
• Experience with regulatory inspections is a plus.
• Knowledge of Good Manufacturing Practices and statistical methods used for Pharmaceutical Process Analysis.

Education

• Bachelors degree in Engineering, Biochemistry or Biology. Other engineering or science degrees considered based on relevant work experience.