No Deviation is a provider of patient-centric solutions for the pharmaceutical industry, and we are currently seeking individuals who are passionate about joining our team. Our areas of expertise include engineering consultancy, Commissioning Qualification Validation (CQV), as well as Quality, Compliance, and Regulatory services.
We strongly uphold our core values of Empathy, Integrity, and Transparency, and we strive to create a collaborative, innovative, and inclusive work environment that fosters personal growth and development.
As a Lead Scientist, you will act as a Study Director to independently design and execute specific virus clearance studies that demonstrate the effectiveness of purification processes for the reduction of viruses to support customers' regulatory filings (IND & BLA).
By joining our team, you will have the opportunity to make a meaningful impact in the pharmaceutical industry while advancing your career.
Roles & Responsibilities:
- Function as a Study Director with the overall responsibility of planning and conducting studies, as well as interpreting, analyzing, documenting, and reporting 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, ultra-filtration, 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.
- Author protocols and reports, and interact with regulatory agencies as required.
- Supervise project teams and lead troubleshooting activities.
- 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, coordinate multiple projects, and ensure timely delivery of project work stages.
Qualifications:
- Degree/PhD in Biological Science/Engineering as appropriate for the area of expertise.
- 4-7 years’ experience or 2-5 years plus a PhD with experience gained in a lab either in industry or academia, or via an industry work training program.
- Practical laboratory experience in virus clearance studies, study directing, and project management is required.
- 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 teamwork skills.
