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