Method Transfer Scientist

One of our large pharmaceutical clients is looking to hire an experienced Method Development Scientist to join it's growing External Quality team within Advanced Therapeutics. This individual will be providing Quality analytical support for site and process qualification activities, engineering runs, and commercial product manufacturing. This individual will need to understand high level principles of how to provide oversight to external manufacturers on lab method developments. Main responsibilies will include:

-Perform complex method development/transfer activities, including method writing and complex method development laboratory work and problem solving applying in-depth practical/theoretical knowledge of relevant concepts and techniques.

-Be responsible for decision making based on the data generated and effective communication with internal and external parties to meet and exceed Sponsor requirements. Anticipate problems that may affect timing, quality, delivery etc. and take appropriate action to resolve any issues, ensuring that regulatory requirements are met and additional costs are captured.

-Lead complex troubleshooting across all aspects of the lab (development, validation, and sample analysis)

-Support monitoring of EM quality performance and proactively identify risks.

-Influence and build relationship with internal and external partners to continuously enhance quality performance.

-Interface with other functions i.e. Operations, Planning, Technical Operations, etc. as well as the external manufacturer

-Apply cGMP regulations and other FDA and international requirements to all aspects of the position.

-Provide on-site support as needed on request of the Janssen team lead

-Bachelor degree in Chemistry, Biology, or related

-10 years of working experience within method development and method transfer

-Experience working with External Manuafcturers on lab method development

-Strong analytical backrgound understanding analytical methods

-Familiar with the use of standard laboratory equipment and analytical instrumentation.

-Effective communication (verbal and written), presentation and interpersonal skills.

-Proven track record of troubleshooting relevant technologies.

-Masters or PhD

-Cell culture, gene therapy experience

Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.