Lead Scientist Ii Viral Dsp

**Position Summary**:
As a Lead Scientist II (LS II), you will be part of a diverse bioengineering team focused on defining and executing process optimization and technology development projects within the cell and gene therapy and regenerative medicine field. You will be responsible for leading, with internal and some external client-facing focus, upstream and downstream process development activities for various products related to cell and gene therapy. The LS II will provide deep technical expertise to increase CCRM capabilities in at least two of the following: process development, integration/automation of upstream and downstream processing, cryopreservation of cell and gene therapy products, ensuring scalability and robustness of processes for future GMP manufacturing, and development of analytical methods for QC release and characterization of cell and gene therapy products.

**Responsibilities**:

- Provide scientific leadership within the organization and for management and in cell and gene therapy project execution.
- Leading one or more projects including; Independently** **define and execute experiments in the field of cell and gene therapy. This includes definition of tasks, experimental planning, experimental execution, data analysis, documentation, reporting of results, providing recommendations and standard operating procedure (SOP) drafting based on assigned project
- Train and lead a small team to execute on project milestones based on projects you are assigned
- Assist in drafting and reviewing statement of work for external partners and/or Customers based on their specific needs
- Engage external customers and partners to understand and overcome workflow challenges and independently prepare and present milestone based data to external customers and partners
- Work within project teams and/or management to identify and prioritize future project opportunities
- Drive effective communication across the organization and management team.
- Demonstrate integrity and a positive attitude in daily performance and establish credibility to motivate others to do the same.
- Provide guidance, mentor, and project leadership, as assigned, to junior staff.

**Requirements**:

- PhD in bioengineering, chemical engineering, bioprocess, biotechnology, cell biology, or a relevant field with 2-4+ years of relevant industry work experience or M.Sc with 8+ years of relevant industry work experience required
- Experience in a biotechnology industry with a particular focus in process development, process scale up, process analytics, analytical product testing, tech transfer or manufacturing.
- Experience in downstream processes for clarification, UFDF and chromatography
- Solid scientific approach with deep experience in experimental planning, design (DoE), statistical analyses, interpretation, documentation and communication.
- Excellent communication and intrapersonal skills.
- Independent, detail-oriented, self-starter with excellent analytical skills and the ability to multitask and succeed in a team environment. People and team management skills are an important asset.
- Must be flexible to support research activities outside of normal business hours, as needed.
- Primarily a lab-based role, with people and project leadership responsibilities.

**Desired Characteristics**:

- Experience with process development, process optimization, analytical development and optimization, workflow simplification for virus production and purification including where applicable
- Experience in viral vector manufactuing production platforms in either wave-mixed (E.g. Xuri Bioreactors) or stirred tank reactors (e,g, Xcellerex, DASbox, and Bioflo/BiBLU bioreactors )
- Experience in characterization assays for cells and proteins (flow cytometry, cell viability/killing, qPCR, ddPCR, particle measurement, ligand binding, enzyme activity, concentration, etc)
- Knowledgeable of the requirements for GMP Manufacturing and QA release
- Experience working with customers

Revision Number**:CCRMLSII-20241003