Our clinical stage vaccine client here in Boston, MA is growing and looking to add a Scientist II, Analytical Development to their team! This will be a hybrid role (2-3 days/week onsite in the lab) and will be responsible for developing methods to perform analytical characterization, lead tech transfers and validation of methods to external laboratories and help improve current methods to increase method robustness and over all assay performance. Other responsibilities include but not limited to:
Develop and execute innovative and/or cutting-edge technologies and strategies to wide range of methods including, but not limited to, liquid chromatography, electrophoretic techniques, and other analytical technologies relevant to the release and characterization.
Provide leadership in the development, validation, and technical transfer of methods to Contract Testing Labs (CTL) for the release, stability, and characterization testing products.
Manage methods through analytical life cycle and identify potential improvements for existing methods and develop remediation plans/timelines to align to overall corporate goals.
Oversee the planning and execution of trending/tracking strategies for method monitoring.
Provide support for reagent sourcing/supply strategy.
Communicate technical information to Senior Management and external partners.
Represent the Analytical Development group in internal meetings and external interactions with vendor laboratories.
Write and review development and GxP technical documents and regulatory submissions.
Utilize external networks to identify, evaluate, and qualify potential partners for the performance of GMP assays and extended characterization.
Support preparation of relevant regulatory filings.
Requirements:
PhD with 2-3 years of industry experience in vaccine or biologics method development, transfer, validation and/or release and stability testing.
Well-developed knowledge of cGMP practices as applicable to analytical development, technology transfer, and method validation is preferred.
Demonstrated technical expertise with practical hands-on experience multiple analytical methods, such as Reverse Phase and Size Exclusion HPLC, UV spectrometry, or electrophoretic techniques (SDS-PAGE, CE-SDS, iCIEF) is required
Experience in biomolecular interaction analysis (Octet, SPR), molecular amplification technologies (ddPCR, qPCR), and/or flow cytometry is desirable.
Knowledge in the areas of Particle Size analysis (FlowCam, NTA, MFI), MALS/DLS, DSC, SV-AUC, FTIR, electron microscopy, or mass spectrometry will be a key differentiator.
Proficiency in statistical software (JMP, R, etc.) for data analysis, tracking, and trending is highly desired.
Other:
Seeking Boston local candidates to be on-site 2-3 days per week, or more depending upon lab work required.
Willingness to travel to various meetings or client sites, including overnight trips.
Some international travel may be required (10-15%)