Senior Principal Investigator
Proclinical is currently recruiting for a Senior Principal Investigator for a biopharmaceutical company located in Wilmington, DE. Successful candidate will be responsible for the development of commercially viable cell lines that will be used in the production of recombinant proteins such as monoclonal and bispecific antibodies.
- Evaluate CHO host and vector technologies of in-house licensed and new CRO technologies to establish platform for mAb production.
- Develop workflow using high throughput technologies for rapid development of commercially viable cell lines with opportunity to select equipment for new lab.
- Represent BPPD and communicate timelines and decisions effectively throughout the company.
- Design and execute studies to ensure production, product quality, and genetic stability of cell lines.
- Qualify single cell plating and imaging workflow to ensure that monoclonality assessments meet regulatory expectations.
- Perform phase appropriate studies and testing to satisfy global health authorities.
- Oversee the creation and maintenance of research cell banks as well as Master and Working Cell Banks manufactured and tested at Contract Labs.
- Participate on working group teams with Discovery and Product Development Team (CMC)
- Develop appropriate number of staff to support multiple new products each year
- Ensure all work is appropriately documented in electronic lab notebook and reports are written in timely manner
Skills and Requirements:
- PhD in molecular or cell biology, chemical engineering, or related field.
- 5+ years' experience in developing high titer CHO cell lines for monoclonal and/or bispecific antibody expression.
- Good knowledge of phase appropriate regulatory requirements for Biotechnology derived cell substrates.
- Experience with high throughput techniques in 384 and 96 well plate format such as: FACS, ClonePix, Cell Printers, Octet, ELISA etc…
- Experience with statistical Design of Experiment is a plus.
- Leadership; ability to build trust and create collaborative environment and relationships.
- Effective planning skills; ability to anticipate resources needs and help establish priorities.
- Ability to develop effective, flexible relationships with others; understands the business agendas and perspectives of others; recognizes and effectively balances the interest and needs within the organization.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Hunter Tonn at (+1) 646-851-0086 or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.