Senior Director, Analytics
Proclinical is currently recruiting for a Senior Director of Analytics with a biotechnology company located in New York, NY. Successful candidate will be responsible for the development, qualification and validation of assays for or AAV-based gene therapy products, as well as oversight of the execution of these assays at contract organizations.
- Development of phase-appropriate testing strategies for viral gene therapy vectors.
- Identification and selection of contract testing organizations for performing development as well as product release testing.
- Responsibility for the development and implementation of assays at contract laboratories.
- Oversight of technical transfer between laboratories, qualification and validation of assays.
- Coordination with internal and external parties, including Program Management, Process Development, Manufacturing, Supply chain, Quality Assurance, Regulatory Affairs and Clinical Operations.
- Timely development of assays as well as testing of samples for material release.
- Identification and communication of risks in assay performance and their mitigation.
- Responsibility to develop, author, review, and/or approve Standard Operating Procedures, specifications, regulatory filing, or other controlled documents as needed.
- Representation of the company as analytical expert.
Skills and Requirements:
- MS or equivalent in Chemistry, Biological Sciences, Engineering or related discipline, with 15+ years of experience; Ph.D. with 12+ years of experience preferred.
- Experience managing team members essential.
- Knowledge in interacting efficiently with Quality Assurance and Regulatory Affairs.
- Expertise in early development as well as late stage/commercial pharmaceutical projects, preferably in gene therapy.
- Experience managing contract organizations.
- Occasional travel to contract organizations required.
- Familiarity with regulatory requirement for testing of viral gene therapy products preferred.
- Excellent written and verbal communication skills, good interpersonal and management skills to collaborate with and direct the work of others on assigned projects (including both internal teams and external collaborators).
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 Matthew Tong at (+1) 646-878-6308 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.