TOGETHER, WE MAKE CANCER CURABLE
Led by an experienced management team of academic professionals and industry veterans, we have built an integrated cell therapy platform with in-house capabilities that span from target discovery, lead antibody development, clinical studies to commercial-scale manufacturing. Our vision is to become a leading biopharmaceutical company developing globally revolutionary cell therapies to make cancer curable. If you are looking for an opportunity with an innovative and solidly growing company, join us.
Key Responsibilities:
- Lead the MSAT team and is responsible for technology transfers both from headquarter to the RTP site
- Responsible for preparing manufacturing batch records and reviewing quality specifications for raw materials and final products
- Execute strategic planning and implementation of MSAT functions
- Drive growth and expansion of MSAT Assess new opportunities based on departmental capabilities, facilities, and resources
- Manage the MSAT budget and efficient utilization of resources
- Facilitate inter/intra-departmental communication
- Escalate issues as needed regarding communications with the project manager
- Direct, develop, and mentor staff.
- Provide an environment that enables collaboration and effective teamwork
- Identify and facilitate change for increased organizational effectiveness and competitive advantage.
- Prepare and review regulatory submission documents
- Support equipment qualification
Requirements:
- Advanced degree in relevant scientific or engineering discipline
- Minimum 10 years of biologics experience, preferably in cell therapy and/or 5 years of experience in a development environment, preferably manufacturing development for cell therapy products.
- Proven ability to lead, coach, and motivate employees, clearly, communicate job requirements and effectively manage the performance of assigned staff with a minimum of three years in a management position.
- Experience with human cell culture, aseptic processing, GMPs, cell-based analytical methods (e.g. FACS, PCR), and sound knowledge of aseptic processing and supporting technologies
- Understanding of current Good Manufacturing Practices
- Working knowledge of routine cell therapy tests such as flow cytometry, CBC analysis, endotoxin testing, sterility testing, laboratory instrumentation, and software.
- Competencies /Candidate Profile Mindset aligned with Carsgen core values: a can-do attitude, highly collaborative, accountability, and adaptability.
- Strong communication and influencing skills and ability to work well in a cross-functional, matrixed environment.
- Driven to deliver high-quality work in a timely manner.
- Flexible and able to adapt to company growth and evolving responsibilities.
- Passion for leadership.
- Drive to develop self and others.
CARSGEN THERAPEUTICS is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation, gender identity, or any other protected class.
To all agencies: Please, no phone calls or emails to any employee of CARsgen about this requisition. All resumes submitted by search firms/employment agencies to any employee at CARSGEN THERAPEUTICS via email, the internet, or in any form and/or method will be deemed the sole property of CARSGEN THERAPEUTICS unless such search firms/employment agencies were engaged by CARSGEN THERAPEUTICS for this requisition and a valid agreement with CARSGEN THERAPEUTICS is in place. In the event a candidate who was submitted outside of the CARSGEN THERAPEUTICS agency engagement process is hired, no fee or payment of any kind will be paid.