Associate Director, Wake Forest Institute for Regenerative Medicine Process Development - Full-time, 40 hours/week
Process Development Associate Director (AD) is expected to develop goals with respect to grants and projects in the translational pipeline to drive advances in speed, efficiency, value and utility of data from Proof-of-Concept to Clinical Trials. The AD will identify and drive value added technical advances in aseptic processing, technologies, techniques, concepts, equipment and generation of data to qualify process to transfer to manufacturing.
The AD must work closely with the RMCC team in Manufacturing, Quality Assurance, Quality Control, Regulatory Affairs and the associated Principal Investigators. The Associate Director will be responsible for management and all staff within Process Development. Responsible for highly and moderately complex and physical, chemical, or biological operations using equipment and procedures. Oral and/or written instructions received from management.
PhD in pharmaceutics, biomaterials, biotechnology, engineering or similar terminal degree. Prior experience as a manager or director within a research facility, cell processing/cell therapy, tissue bank or pharmaceutical company required. Leadership experience should include new product development, implementation management, technology transfer, statistical process design, analysis of experiments and/or process/product characterization. Prefer experience in biomaterials and scaffolds in Tissue Engineering.
Reports To: Director, Regenerative Medicine Clinical Center
1. Develop and maintain a high level of experienced scientists and engineers with advanced degrees for process and product development.
2. Drive continuous improvement in the development process for, biologics, drugs, devices and combination products by driving the innovation and align with manufacturing and regulatory requirements.
3. Guide and mentor teams in process development leading projects during commercialization.
4. Identify critical scientific and business decisions that must be addressed that require management during product/process lifecycle.
5. Deliver progress, technical and quarterly reports to confirm management is aware of current status, progress and future needs to meets the needs of the grant or collaborative effort.
6. Assure appropriate talent within Process/Product Development including hiring, development, mentoring and training to meet compliance with regulatory requirements and quality systems of GMP.
7. Develop and maintain a system within PD for solution preparation records, batch records and Standard Operating Procedures including all documentation that will be transferred to manufacturing at technology transfer.
8. Guide and develop in-process testing, lot release testing, potency testing (if applicable) and analytical testing required as determined by project.
9. Responsible for ensuring team members understand project objectives, deliverables and timelines through consistent and clear communication.
10. Provide direction to project manager in regards to changes opr amendemnts to statement of work.
11. Identifies issues and challenges that may creat delay or additional financial considerations and makes recommendations in regards to appropriate mitigation of risk and startegies to assure program success.
12. Assure product development falls within financial aspects and timelines of grants or collaborative effort.
Skills and Qualifications:
Experience in problem solving, trouble shooting and communication skills with staff at many levels and in cross functional teams working effectively in a team to drive development
Experience leading technical experts with new product development to first in man
Strong knowledge of aseptic processing, manufacturing, biotechnology products, associated GMP documentation and regulatory filings
Advanced understanding of primary containers, equipment, labelling, packaging and cold chain expertise Experience working with cell cultures in flasks and bioreactors, culture media optimization, cell culture associated operations for harvest, concentration, centrifugation, cryopreservation, thaw and recovery of cells Knowledge of assays to characterize cells/constructs
Proven ability to learn and act on dynamic information at a rapid pace
Excellent recordkeeping and documentation skills
Strong communication skills, both verbal and written
Understanding of Microsoft Office products (i.e. Word and Excel) and other computer software
Outstanding interpersonal skills, high energy and motivated
Office and lab setting
Clean, well-lit climate
Exposure to bloodborne pathogens, chemicals, research animals
May be subject to evening or weekend hours and some overnight travel may be required.