| Position Summary: Rutgers, the State University of New Jersey is seeking Process Development Managing Director for the Cancer Immunology and Metabolism department at Rutgers, Cancer Institute of New Jersey (CINJ). The Managing Director, Process Development (Cellular Therapy) is to initiate and run a shared service for cellular and immunotherapy development. This position is responsible for working with collaborating laboratories to transfer, develop, and implement methodologies for the production of translational products and projects. This position will lead the process development team. Among the key duties of this position are the following: - Directs the daily activities of the process development laboratory.
- Manages a group of highly trained technicians that comprise the process development team.
- Generates Chemistry, Manufacturing, and Control (CMC) documents for Investigational New Drug Applications (INDs).
- Generates validation plan for new products.
- Supervises validation experiments for new products.
Minimum Education and Experience: - Master’s Degree in Biomedical Science, Biology, Chemistry, Engineering or related field.
- Five (5) years in scientific research with five (5) years of experience in supervising/managing cellular therapies labs, cGMP facilities, in vitro cell culture, related analytical labs, experimental and clinical trials studies, and FDA IND submissions.
- Experience in participating and leading cross-functional/matrix project teams.
Required Knowledge, Skills, and Abilities: - Knowledge of cGMP, GCP, FDA, FACT, and AABB.
- Knowledge of laboratory and regulatory requirements in cellular therapy related research.
- Working knowledge of IRB and regulatory approvals and developing FDA IND submissions.
- Working knowledge of Materials and Technology Transfer including transitioning of research techniques into cGMP production methods and start-up of existing or new processes at internal and external manufacturing facilities.
- Knowledge of Microsoft Suite (Word, Excel, PowerPoint, Visio) and general analytics.
- Demonstrated ability to work in a fast-paced environment supervising multiple projects and activities simultaneously.
- Possesses personal leadership qualities that inspire trust, respect, credibility, and confidence of peers and colleagues and takes the organization to a higher level.
- Knowledge of Stem Cell literature and experience in science-based cGMP manufacturing, demonstrated innovative thinking.
- Well-developed interpersonal skills; experienced communicator, ability to provide clear and logical presentation of complex strategic issues.
- Demonstrated ability to manage people and to assign work effectively based on staff skills.
- Proven ability to design and implement studies with direct translation.
- Resilient, energetic, and enthusiastic, responding constructively to challenging new ideas and inputs.
- Strategic thinking: innovating with informed, sharp, and objective practical purpose, experienced in detailed analysis, interpretation, and reporting.
- Strong interpersonal skills and networking.
- Ability to develop productive relationships with academic scientists and research/business executives in the biotechnology, pharmaceutical, and medical device industries.
- Proven ability to maintain effective oversight of a project and schedule progress to predetermined milestones, experience in developing and monitoring detailed budgets.
- Demonstrated ability to handle pressure and ambiguity; comfortable with the pressure to excel and ability to maintain focus in situations of ambiguity and uncertainty.
- Effective oral and communication skills.
- Computer literate with proficiency and working knowledge of database and reporting tools such as Microsoft Word, Excel, Access, and PowerPoint.
Preferred Qualifications: - Ph.D. strongly preferred.
Posting Number: 20ST2380 Location: Downtown New Brunswick |
