Mid-level industry position
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- Job Locations US-PA-Philadelphia
Independent Scientist with in-depth knowledge of Southern and Northern blotting techniques to direct GMP testing as well as research and development as needed. Functions as a technical reviewer and subject matter expert under limited supervision. Demonstrates solid proficiency in scientific theory and rigorous practical application in the completion of lab procedures. Drafts test methods and clearly documents all experiments according to SOPs and cGMP guidelines. Demonstrates strong oral and written communication skills and actively contributes to staff training. Designs and participates in the execution of assay qualifications and test article validations. Participates in client calls and face to face meetings with assistance by senior staff. Maintains testing schedule and acts as a liaison with Client Delivery to meet timelines. Partners with Analytical Development during assay transfer and validation activities.
- Acts as the technical reviewer for assays, conducts critical review of results, issues reports and assumes all associated responsibilities.
- Designs studies to assess the genetic stability of cell banks using Southern blotting using radioactive and dioxygenin labeled probes.
- Conducts and directs assays and lab procedures according to and in compliance with cGMP, CFR and/or PTC guidelines and SOPs.
- Conducts critical review of results and interprets the data. Draws conclusions and plans next steps for assay development or troubleshooting.
- Drafts test methods, client protocols, and standard operation procedures (SOPs).
- Writes GMP and R&D reports and ensures data are reported clearly and accurately.
- Executes Qualification and Validation Protocols (QP/VP) and other GMP methods, as needed.
- Participates in inquiries of non-conforming events, deviations and laboratory investigations. Evaluates compliance trends and implements corrective actions.
- Thorough understanding of Good Manufacturing Practices.
- Orders reagents and materials, initiates work orders, as needed.
- Author and execute IQOQs and equipment SOPs, as required.
- Ability to work in a team environment and independently as needed.
- May be required to work Holidays and weekends.
- Perform job specific tasks in compliance with applicable Regulations, International Standards, and WuXi AppTec Policies and Standard Operating Procedures.
- Extensive experience with Southern and Northern blotting techniques.
- Experience with DNA and RNA extraction, qPCR and molecular biology techniques.
- Familiarity with ddPCR is desired.
- Experience in a cGMP environment is highly desirable.
- Ability to use judgment as dictated by complexity of situation.
- Ability to work under limited supervision and to handle problems of a more difficult nature.
- Proficiency with multitasking including the aptitude to adjust priorities in response to dynamic circumstances.
- Ability to accomplish the described duties through the use of appropriate laboratory equipment and computer equipment and software.
- Ability to record data accurately and legibly.
- Attentiveness and adherence to the highest quality standards.
- Proficient in Oral & Written communication skills.
- Proficient in Microsoft (Excel, Word, Outlook).
- Knowledge of statistics is desirable.
Our greatest asset is our people, WuXi is dedicated to providing opportunities for internal growth with direct access to a dedicated and accessible Human Resources team.
WuXi AppTec provides equal employment opportunity to all individuals regardless of their race, color, creed, religion, gender, age, sexual orientation, national origin, disability, veteran status, or any other characteristic protected by state, federal, or local law.
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