Hobson Prior are currently working with a late-stage biotech organisation specialising in improving health all over the world through discovering, developing and commercializing pioneering vaccines to prevent serious diseases. Our client is seeking a Director (Downstream Process Development) to join them on a permanent basis based in Gaithersburg.

Job Responsibilities:

• Accountable to lead a group responsible for the development of consistent, high-yielding, high-purity, scalable, validatable, and economical downstream purification.
• Demonstrate sound scientific and technical understanding when optimizing a process.
• Recognise, apply, and develop new technologies to advance purification capabilities.
• Design, in conjunction with staff, well-thought out experiments using a Design of Experiments approach incorporating QbD into the process characterization.
• Assist in scale up, characterization, and optimization of all programs. Provide support for critical operations as needed in our GMP manufacturing facility.
• Accountable for supporting and/or leading process validation activities and strategies including evaluating downstream process characterization plans from process validation protocol creation to report writing.
• Responsible for project coordination and resource management including identification of personnel hiring requirements and skill set gap analysis.
• Partake in tech transfer to other groups and external partners.
• Thoroughly analyse results and methods, troubleshoot processes, generate solutions to problems, and meet regulatory expectations for process development.
• Any other tasks assigned.

Key Skills:

• Ability to manage a team of scientists/engineers and develop and motivate team to achieve results.
• Ability to define priorities and process to get things done.
• Ability to work effectively with cross-functional groups. Experienced in process tech transfer.
• Ability to critically review data and technical reports.

Requirements:

• BS, MS or Ph.D. in Engineering, chemistry or biological science with commensurate years of experience.
• Ability to improve product purity and yield with economically viable process choices.
• Strong expertise in process design and development of downstream unit operations with a thorough understanding of chromatography separation and viral inactivation.
• Strong understanding of FDA regulatory requirements associated with process characterization and documentation of vaccine products.
• Knowledge and expertise in principles and practice of current Good Manufacturing Practices.
• Present scientific findings at internal and external meetings.

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.