Molecular Testing Scientist

Proclinical is currently recruiting for a Molecular Testing Scientist with a pharmaceutical company located in Philadelphia, PA.

Job Responsibilities:

• Accurately generates and completes test methods and other required documentation in compliance with cGMP, CFR and/or PTC guidelines and company Policies and SOPs.
• Demonstrates innovative thinking and technical expertise in PCR based assays including extensive knowledge of data analytics.
• Designs and independently conducts research and development projects from inception to completion.
• Reviews sample submission documentation, initiates studies and maintains due dates in our Laboratory Inventory Management System (LIMS).
• Conducts and directs assays following approved laboratory procedures and assumes all associated responsibilities.
• Schedules and manages team of technicians to execute residual DNA assays under supervision of Department Management.
• Conducts impartial laboratory investigations to identify performance trends and implements corrective actions.
• Performs critical review of testing documentation, prepares reports and issues results in LIMS.
• Functions as Subject Matter Expert (SME) on Core Teams, in regulatory audits and Client Calls.
• Contributes independently to the overall scientific rigor of laboratory operations.
• Trains new staff on laboratory procedures and assays as needed.
• Weekend and holiday work may be required.
• Other duties as assigned

Skills and Requirements:

• PhD, Minimum of 2-3 years of experience with qPCR assays
• A minimum of 5 years of Molecular Biology experience or educational equivalent with a degree in Biological Sciences or science related major.
• Experience designing and troubleshooting sequencing assays and the ability to explain unexpected results and solve technical issues is required
• Practical knowledge of qPCR and other molecular based techniques is required.
• Ability to use judgment as dictated by complexity of situation, work under limited supervision and to handle problems of a more difficult nature.
• Familiarity with current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP) is preferred.
• Knowledge of ddPCR technology or automated laboratory instrumentation is a plus.
• Ability to accurately and reproducibly perform arithmetic calculations including fractions, decimals and percentages and basic algebraic and geometric calculations.
• Proficient in Verbal & Written communication skills.
• Proficient in Microsoft (Excel, Word, Outlook).

If you are having difficulty in applying or if you have any questions, please contact Dominic Santoro at 215-531-5280.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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