Flow Cytometry Scientist

Flow Cytometry Scientist

49_744000039653685

Obowiązki

General Responsibilities:

Perform testing in support of product manufacturing, employing manual and automated analytical equipment. Provide direct support of Quality Control analytical processes, test procedures, qualifications, validations, assay troubleshooting, equipment upkeep, logbook review, and inventory control.

Position Details:

• Execute Analytical Test Methods for in-process samples, bulk intermediate (drug substance), final drug product, and raw materials release/stability testing. Primary testing responsibility will be conducting flow cytometry testing to support assays such as percent transduction efficiency and CD90. However, cross-training in cell culture and other analytical methods will be required (e.g. ELISA, qPCR).
• Coordinate, schedule, and execute testing based on manufacturing schedules.
• Participate in the review process of SOPs and analytical test procedures as necessary to maintain compliance.
• Review Quality Control raw data for accuracy, completeness and compliance with effective SOPs to ensure the strength, identity, safety, purity and quality of the product.
• Troubleshoot and analyze nonconforming data.
• Perform timely response to Out of Specification (OOS) results, including notification to area management. Perform and document laboratory investigations to ensure that potential problems and root causes are identified, impact assessed and actions to prevent recurrence are considered and implemented. Execute associated CAPA.
• Ensure data integrity is maintained for all applications, programs, and executed work. Ability to document all work using Good Documentation Practices and ALCOA++ principles.
• Maintain laboratory housekeeping including organization, cleanliness, and logbooks.
• Perform internal audits and GEMBA walk-throughs of laboratory areas to maintain compliance.
• Author and/or execute protocols and generate technical reports.
• Author and manage change controls.
• Performance of equipment standardizations and qualification, as necessary.
• Perform training of other employees.
• Communicate with the individual Operations Departments (Manufacturing, Quality Assurance, Facilities) to ensure that Company objectives are met on schedule.

Wymagania

Basic Minimum Qualifications:

• BS in biochemistry, chemistry, or similar scientific discipline
• 3+ years in a quality control GMP environment specifically working on Flow Cytometry methodology in a similar role in the biologics industry
• 2+ years of mammalian cell culture in an academic or industrial laboratory
• At least a year of working in a cGMP and GDP environment in the pharmaceutical industry
• Familiarity with analytical equipment such as UV absorbance plate readers, Flow cytometers, microscopes, and pH meters is recommended
• Excellent verbal and written skills with good interpersonal communication skills
• Must be open to occasional off shift and weekend work
• Must be eligible to work in the United States indefinitely without sponsorship.

Oferujemy

Position is Full Time, First Shift - some evening and weekend work may be required as needed. Candidates currently living within a commutable distance of Exton, PA are encouraged to apply.

What we offer:

• Excellent full time benefits including comprehensive medical coverage, dental, and vision options
• Life and disability insurance
• 401(k) with company match
• Paid vacation and holidays
• Yearly goal-based bonus & eligibility for merit-based increases

Eurofins USA PSS Insourcing Solutions is a M/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.

Źródło: Eurofins/Praca

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