MS&T Scientist/Senior Scientist

Hobson Prior are currently looking for a MS&T Scientist/Senior Scientist 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:

• You will be accountable to transfer and implement the proposed process to demonstrate it is robust, high purity/yield, economic and scalable for clinical stage manufacturing of nanoparticle vaccine and other biologic product candidates.
• Ensure unit operations are feasible to implement at the intended manufacturing scale.
• You will perform and analyse Design of Experiment studies to develop or optimizing processes to ensure a phase-appropriate, consistent, high-yielding, high-purity, and scalable downstream purification.
• Capability to process complex data and communicate clearly and timely the implications of the results.
• Responsible to co-operate and coordinate with colleagues from Discovery, Process Development, Analytical Development, Manufacturing, and QA/QC teams.
• Develop and implement process validation strategy including validation protocol writing, execution and report writing.
• Generate, manage, evaluate, and maintain critical data in a highly organized manner. Provide reports for assessment by senior management.
• Assist in scale up and optimization of early stage processes, support critical operations as needed in our GMP manufacturing facility and deliver materials for pre-clinical and clinical studies.
• Provide reagents and other supplies for various projects and departments.
• Accountable for integrating robust viral clearance steps into the process and working closely with the Viral Clearance Validation team, including review of protocols, execution of studies, and report writing.

Key Skills:

• Capable of performing multiple functions in a fast-paced environment.
• Strong technical protocol/report writing, and good organization skills are required.
• Proficient in Window based software including Excel, PowerPoint and Word.
• Demonstrated verbal and written skills in communicating scientific and technical information.
• Excellent record keeping abilities to adequately record, analyse and document data generated in support of regulatory requirements.

Requirements:

• A Ph.D. Degree with more than 2 years of relevant industrial experience, or MS with more than 5 years relevant industrial experience in Biochemistry, Microbiology, Biology, or closely related field.
• Biologic/Vaccine manufacturing experience is required. Multi-year industrial purification experience with approved vaccines/biologics is preferred; direct experience with virus-derived recombinant products and/or viral particles is a plus.
• Diverse knowledge and experience in various relevant areas, including but not limited to molecular/cell biology, harvest, formulation and common analytical tools is preferred.
• Strong understanding of FDA regulatory requirements associated with analytical characterization and documentation of vaccine products.

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.