Lead Scientist - Emory, United States - EPM Scientific

EPM Scientific Emory, United States

3 weeks ago

Description

Job Opportunity:
Lead Scientist (Study Director), Viral Clearance

Company:

Join a leading multinational leader in the CDMO industry, responsible for development and characterization manufacturing processes used for the production of novel therapeutic recombinant proteins for their client base.

We are currently seeking a dynamic and passionate Lead Scientist to join our team in Singapore.

Key Responsibilities

Function as a Study Director, who has the overall responsibility of planning and conducting, as well as the interpretation, analysis, documentation and reporting of results.

Design viral clearance studies in accordance with guidelines (e.g. EMEA and ICHQ5A) and perform hands-on laboratory work (e.g. small-scale control run, virus models spiked run, virus inactivation step evaluation, virus reduction filtration) following protocols and working to GMP standards.

Follow work procedures to set up and operate chromatography, ultrafiltration and dead-end filtration systems to GMP standards.

Review and interpret raw data to produce good quality process knowledge and data sets suitable for inspection by regulatory agencies.

Authoring of protocols and reports and interaction with regulatory agencies required.

Supervision of project teams and leading troubleshooting activities required.

Develop and manage relationships with external customers and teams at contract testing laboratories.

Deliver high quality communication to ensure an outstanding customer experience (written reports, telecons, face to face meetings).

Work as part of a site and global project team, co-ordinate multiple projects and ensure timely delivery of project workstages.

Requirements

Degree/PhD in Biological Science/Engineering as appropriate for area of expertise.

4-7 years' experience or 2-5 years and a PhD with experience gained in a lab either in industry or academia, or via an industry work training programme.

Practical laboratory experience in virus clearance studies, study directing and project management is required.

Developing a detailed understanding of the scientific rationale behind one or more technical areas involved in the development of biopharmaceuticals.

The final role offered will be commensurate with the candidate's experience.

Understanding of cGMP regulations and quality management is required.

Excellent problem solving and analytical skills.

Excellent communication skills (verbal and written).

Excellent team work skills.

How to Apply

If you are enthusiastic about making a meaningful impact in the field of the CDMO industry and possess the required qualifications and experience, we invite you to apply for this exciting opportunity.

Please submit your resume to this job advert.

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