Senior Director, Analytical Method Development
Location: West Palm Beach, FL
Exuma Biotech is looking for another individual to share our passion for making a lasting difference in the fight against cancer.
The big picture is:
This position will report directly to the VP of Oncology Research and Development and will support clinical research and development programs working in our new laboratory. The selected individual will be expected to be well organized and meticulous in their approach to complex experiments and be able to both understand the aim as well as communicate results and present conclusions. EXUMA Biotech promotes matrix project management and therefore expects all employees to collaborate with others and share experience openly to achieve our goals.
Why join us?
Exuma Biotech is a clinical-stage biotechnology company committed to discovering, developing, and commercializing cell and gene therapies for the treatment of cancer. The company has rapidly built its core technologies via a growing global presence with operations in the US and Asia and headquarters in West Palm Beach, Florida.
This is a full-time position working with a great team and with excellent benefits including medical, dental, vision, life insurance, 401K plan with a company match, and unlimited PTO.
This is an exciting opportunity in sunny West Palm Beach, FL to develop next-generation analytical methods with quality control for the rapid release of an innovative Cell Therapy Process/Platform based on EXUMA’s novel lentiviral technology. Your role as the Senior Director/Director of Analytical Methods Development will involve developing, qualifying, and validating cell culture, flow cytometry, PCR, and ELISA-based assays to characterize gene-modified cell products following pre-manufacturing engineering runs at production scale for the development of a subcutaneous product for clinical trials. Importantly, you will play a major role in transferring the key release assays to GMP manufacturing facilities to enable early phase clinical trials and developing new foundations of regulatory science in support of novel platform technologies.
Here are some of the responsibilities:
- Investigates, creates, and develops novel analytical methodology and validation strategies compatible with a quality environment
- Optimizes, characterizes and develops flow cytometry, PCR, and ELISA based assays
- Manages analytical methods technicians with an ability to mentor and guide research associates
- Performs quality control of data generated during engineering and production runs
- Draft and review SOPs, Master Batch Records, Bill of Materials, and other technical documents related to technology and process transfers to GMP production/ manufacturing facilities
- Authorship of CMC sections of regulatory filings and supporting documents with a clear ability to contribute and execute the analytical method strategy
- Provide support for CMC, CDMO (onsite), training of new technicians/operators, and execution of technology/process transfers.
- Experience in immunobiology with proficiency in flow cytometry and ELISA based assays
- Experience in molecular biology with proficiency in cell culture and PCR-based assays
- Write protocols, reports with statistical analysis, policies, risk assessments, and other related procedures for regulatory support, technology transfer, and internal use
- Perform troubleshooting and preventative maintenance of laboratory equipment
- Provide technical assistance, guidance, and training to other laboratory personnel
- Prepare data for internal and external meetings and presentations
- Maintain a level of technical knowledge and understanding in the assigned areas of responsibility that are consistent with the current scientific requirements of the company
- Participates on cross-functional teams both internally and externally
We are looking for candidates with this background and education:
- Ph.D., M.D., or equivalent degree from an accredited institution plus 10+ years of relevant experience in Cell and Gene therapy processing and manufacturing
- Excellent communication and collaboration skills
- Demonstrated leadership and managerial skills
- Hands-on experience with flow cytometry, qPCR, and ELISA-based assays
- Ability to illustrate complex issues and to evaluate them critically as well as to navigate a goal-orientated decision process
- Possesses planning and organizational skills
- Able to manage a number of projects simultaneously
- Experience in multicultural environments
- Experience working in Oncology or Immuno-oncology field – Preferred
- Proven ability to work efficiently and independently
- Strategic thinker, self-starter, and results-oriented
To apply or obtain additional information, contact: firstname.lastname@example.org with your resume and cover letter or use the form below.