Hobson Prior are currently looking for a Director of Analytical Development to join a late-stage biotech organisation, specialising in improving health all over the world through discovering, developing and commercializing pioneering vaccines to prevent serious diseases. This is a permanent position, located in Gaithersburg Maryland.

Job Responsibilities:

• Accountable to establish an Analytical Development laboratory capable of performing all release and in process testing required for the company's product portfolio.
• Develop a comprehensive Analytical Development Program that includes troubleshooting of existing methods as well as developing new analytical methods.
• You will lead a cross-functional team to establish a strategy for development stage-appropriate master specifications for vaccine products.
• Responsible to hire junior staff to perform all the necessary release testing.
• Develop a comprehensive Critical Reagent/Reference Standard Program including the preparation, qualification, stability monitoring, and inventory management of critical reagents used for vaccine product testing.
• Partake in analytical technology transfer activities to QC and outside laboratories and manage contracts for outside testing.
• Assist in assay qualification and validation activities and manage timelines to meet project needs.
• Oversee sample management to ensure proper turn-around time for assay testing and result reporting. Prepare Data summary reports and technical reports.
• Interface with IT for Development Informatics support, such as DLIMS and chromatography control systems.
• Accountable for instrument maintenance and service contracts, laboratory service management, and contracts for external testing and reagent supply for the Analytical Development department.
• Align Reference Standard and critical reagent practices across the organisation (U.S., Czech and Sweden sites).

Key Skills:

• Strong Leadership skills and the ability to work collaboratively and cross functionally.
• Strong communication skills.
• Excellent organisation and record keeping skills to timely record, track and analyse sample testing and analytical data.

Requirements:

• Ph.D. in biological science or biochemistry.
• Experience in preparing analytical sections of regulatory documents such as IND, BLA and regulatory discussion documents.
• A minimum of 12 years' experience in analytical chemistry in biotechnology industry.
• A solid understanding of FDA and ICH guidelines for critical reagents, Reference Standards, and master specifications.
• Previous experience in leading an Analytical Development/QC program that includes lifecycle management of analytical methods.
• Previous experience building programs for critical reagents, Reference Standards and master specifications.
• An in-depth understanding of biochemistry, protein chemistry, analytical techniques for biotechnology product characterization
• Good understanding of FDA regulatory requirements and GMP practice associated with analytical analysis and documentation of vaccine products
• Proficient in preparation and review of technical reports.
• Proficient in Window based software to include Excel, Word, Access and PowerPoint (at least one year of experience with LIMS would be desired).

Apply now:

If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.