Scientist, Research Scientist

We are looking for driven, talented Scientist to join the Functional Method Development & Transfer (MDT) group. The MDT group is an integral part of manufacturing process and provides technical and operational leadership for new product introduction, and increasing quality and yield in production environments. These highly collaborative, flexible and dynamic individuals partner cross-functionally with R&D, Quality, Production and other engineering groups.

This is a hands-on, independent position where the incumbent is responsible for the design and execution of experiments for product/process optimization, development/optimization of functional nucleic acid based test methods, and NGS methods, qualification and/or validation activities ensuring the successful technology transfer into a GMP manufacturing environment. Assistance with general lab management and equipment onboarding support may be required.

Responsibilities:

• Conduct laboratory work; following written protocols; execute test methods as assigned.
• Help to establish process or quality control (QC) method requirements to meet product specifications
• Collaborate and guide new product introduction teams throughout the stages of product development process (PDP) in order to:
  
  Act as a liaison between development and manufacturing teams.
• Participate in the construct and execution of controlled experiments (including DOEs, gauge R&R studies) to develop/optimize manufacturing ready production workflows or test methods.
• Participate in the construct and execution of qualification and validation experiments.
• Monitor, trend and analyze results from development and pilot lots during the NPI process; track off-targeted production outputs, troubleshoot/perform root cause analysis, and make technical and compliance related recommendations as required.
• Present clear and concise written and oral communications to colleagues and supervisors, lead and participate in technical meetings, and provide recommendations based on results.
• Participate or author technical documents, such as plans/protocols, engineering reports, SOPs, or other manufacturing related documentation.
• Participate in software and instrument validation for NPI transfer into Reagent QC.

Requirements:

• Demonstrate capability to support the process and/or test method development activities.
• Knowledge of various laboratory techniques, may include but not limited to, library prep methods, NGS methods, nucleic acid-based techniques (e.g. PCR, probe enrichment/hybridization, etc.) and biochemical (enzymatic) assays.
• Ability to communicate effectively and build strong relationships across multiple departments.
• Ability to work in fast-paced environment; easily adaptable to changing priorities.
• Ability to take lead role in managing general laboratory maintenance and support equipment onboarding as needed.

Highly Desired:

• Experience in editing or troubleshooting automation methods/workflows (Hamilton/Tecan).
• Proficiency with library preparation and next generation sequencing (NGS) techniques.

Education:

• B.S./M.S./ PhD in Biochemistry, Chemistry, Biological Sciences, Physical Chemistry or equivalent disciplines with 3+ years of experience.