Scientist-Residual Methods

SCIENTIST-RESIDUAL METHODS FREDERICK, MD Onsite Position. Project Description:

• The Scientist plays a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients' lives.
• This position is responsible for supporting commercial bioassay activities within Global Technical Operations analytical method transfer, validation, training, and trouble shooting.
• This is a lab-based position.
• You will be responsible for conducting or participating in technically fast paced projects within your specific area or field.
• Responsible for performing and troubleshooting ELISA-based methods, while applying these methods to a broad range of late stage, phase 3 clinical and commercial products in a GMP environment.
• Responsible for maintaining technical expertise on several analytical areas and instrumentation.
• Maintaining up-to-date familiarity with applicable regulations and regulatory guidance associated with analytical method design/transfer/validation requirements.
• Manage authoring, review and approval of all technical documents, qualification protocols, SOPs, reports, and Certificates of Analysis as well as the coordination of all lab work necessary to complete qualifications on time.
• Author/Review sections of regulatory submissions related to residual-based methods and validation.
• In alignment with department/company strategic initiatives, influence and implement technology upgrade and continuous process improvements to analytical testing.
• Establish harmonized processes and best practice on various activities related to global critical reagents.

• At least four years of experience with B.S or 2 years with M.S. working in the biopharmaceutical or related industry experience.
• Experience with validation and troubleshooting ELISAs to support commercialization of different products.
• Working knowledge of molecular based (PCR) assays is a must.
• Experience working with stable cell line generation and BSL2 level biological agents.
• Proficiency in utilizing statistical software for design of experiments and dose-response curve analysis (PLA, JMP, DoE, SoftMax Pro, etc.).
• Ability to apply critical thinking to solve problems and work independently.
• Strong interpersonal and communication skills.