- Lead technology transfer activities for autologous cell therapy programs, including process development, scale-up, and manufacturing optimization.
- Develop and implement comprehensive technology transfer strategies to facilitate the successful transition of processes from research to manufacturing.
- Serve as the primary point of contact for internal and external partners involved in technology transfer activities, including research scientists, manufacturing teams, and external collaborators.
- Collaborate with cross-functional teams to identify and address technical challenges and ensure compliance with regulatory requirements.
- Drive continuous improvement initiatives to enhance efficiency, scalability, and robustness of manufacturing processes.
- Develop and maintain documentation, including standard operating procedures, batch records, and technology transfer protocols.
- Participate in tech transfer project planning, budgeting, and resource allocation activities.
- Provide technical expertise and guidance to support process troubleshooting and optimization efforts.
- Stay abreast of industry trends, best practices, and emerging technologies related to autologous cell therapy manufacturing.
- Build and sustain strong relationships with internal and external stakeholders to meet Business requirements.
Required Skills/Abilities - Experience with autologous cell therapy products and associated manufacturing challenges.
- Familiarity with analytical methods and characterization techniques used in cell therapy manufacturing.
- Prior experience in managing cross-functional teams and external partnerships.
- Understanding of cell therapy regulatory requirements in major markets such as FDA and EMA.
- Great verbal and written communication skills with the ability to interpret, summarize, and present scientific results in a concise manner to both technical and non-technical audiences.
- Self-motivated and willing to accept responsibilities outside of initial job description.
- Self-awareness, integrity, authenticity, and a growth mindset.
- Ability to distill complex information and tailor verbal and written communications in a concise, logical, and audience appropriate manner.
Education and Experience - PhD or Master's degree in Bioengineering, Chemical Engineering, Biotechnology, or related field.
- Minimum of 6 years of experience in technology transfer, process development, or manufacturing within the biopharmaceutical or cell therapy industry.
- Proven track record of successfully leading technology transfer projects from research to manufacturing scale.
- Strong understanding of cell therapy manufacturing processes, including cell culture, cell isolation, and cryopreservation techniques.
- Experience with cGMP regulations and quality systems in a regulated environment.
- Excellent project management, communication, and leadership skills.
The anticipated salary range for candidates who will work in Santa Monica, CA is $160,000 to $184,000. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job type and length of experience within the industry, education, etc.
At Neogene we celebrate the diversity of our employees and our leadership. Neogene is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status or any other characteristic protected by law.DE&I Statement
Headline: We embrace our individual differences.
"Our mission is to build a workforce reflective of our communities to be receptive to patients' broad and unique perspectives, enabling us to empathize with their needs. Together, we strive to uphold a value system that promotes:
- Opportunities for continuous learning to drive behavioral change and to be respectful of other points of view
- A collaborative culture that leverages the diverse perspectives of employees and supports courage
- Zero tolerance for discrimination
We are committed to an emotionally and psychologically safe workplace that trusts employees to boldly explore innovative solutions. We recognize that intentionally embracing diversity at Neogene, empowers us to better relate to patients, and advance our mission to deliver cures where none exist." - Opportunities for continuous learning to drive behavioral change and to be respectful of other points of view
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Associate Director, Tech Transfer Autologous Cell Therapy - Santa Monica, United States - Neogene Therapeutics
Description
Pushing the frontier of solid cancer therapy, Neogene Therapeutics is a global, clinical stage biotechnology company built on the premise of innovation and novel paradigm-changing science. Using tumor mutation profiles to engineer fully individualized T cell therapies, Neogene is bringing new hope to address the current limitations of treatments available today.
We offer the opportunity to join a highly dynamic biotech with locations in Amsterdam, Netherlands and in Santa Monica, CA. You can expect a collaborative environment created by a team with deep scientific expertise and an industrial track-record in T cell therapies.
Neogene values pro-active team-players who pursue their goals with dedication, endurance, and a daring mindset. If you share our commitment to make a difference to patients in need, we can provide an exciting opportunity for your career.
Position Summary
We are seeking a highly skilled and motivated Associate Director of Technology Transfer to join our dynamic team. The successful candidate will play a pivotal role in facilitating the transfer of novel autologous cell therapy technologies from research and development into manufacturing and commercialization. This individual will lead cross-functional teams and collaborate closely with internal and external stakeholders to ensure seamless technology transfer processes.
This position is based in Santa Monica, CA and reports to the Director MSAT.
We offer the opportunity to join a highly dynamic biotech start-up. You can expect a collaborative environment created by a team with deep scientific expertise and an industrial track-record in T cell therapies. We value pro-active team-players who pursue their goals with dedication, endurance and a daring mindset. If you share our commitment to make a difference to patients in need, we can provide an exciting opportunity for your career.
Essential Functions and Responsibilities
