Director, Manufacturing Sciences & Technology and Tech Transfer (MSAT)

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
Neogene Therapeutics is a clinical stage biotechnology company aiming to change the paradigm of treatment for solid cancers. Our mission is to provide cancer patients with T cell therapies targeting mutated proteins called neo-antigens, which are present on cancer cells as a consequence of DNA mutations. Neogene is developing novel technologies to enable the engineering of 'designer T cells' with neo-antigen specificities that display an optimized ability to seek and destroy cancer cells.
We are seeking a highly motivated individual to join our Process Development Team in Santa Monica, CA as Director MSAT and Tech Transfer. The ideal candidate is responsible for managing a diverse range of projects that spans from Tech Transfer activities to technical manufacturing support and process improvements implementation. The complexity of the work demands a solid technical background across a variety of scientific disciplines and fundamentals (Tech Transfer, manufacturing process technologies, biopharmaceutical best practices, statistical analysis, technical documents authoring etc.).
Responsibilities include, but are not limited to:

• Create templates to support and implement technology transfer business process including technical documentation, gap assessments, RACIs, risk assessments, verification/validation protocols and reports.
• Perform all MSAT activities associated with process transfer and process support and drive technology transfer planning, development and execution of timelines to meet project goals, working with project teams
• Lead the Technology Transfer from Process Development to Operations.
• Perform process monitoring, author campaign summaries, perform activities for continue process verification activities.
• Give technical and Technological support during the clinical trial production activities, with the objective to deliver the pharmaceutical product on time and in compliance with cGMP.
• Maintain accurate records of experimental results, analysis and interpretation of experimental data.
• Build & deliver training presentations to manufacturing and other departments.
• Prepare and present technical reports and data to appropriate groups.
• Support regulatory filings, site readiness, and facility startup as needed.

Requirements:

• Experience in new product introductions/manufacturing/ manufacturing science and Technology/technical development/quality/R&D.
• Experience in Tech transfer, production and engineering.
• Excellent organizational and managerial skills with experience in the supervision of junior research staff.
• Comfortable with electronic document management systems and authoring tools.
• A strong sense of urgency with regards to work duties and the ability to deliver results based on challenging timelines.
• Strong verbal and written communication skills and the ability to communicate results to a diverse cross-functional audience.
• Comfortable in a fast-paced growing company environment and able to adjust workload based upon changing priorities.
• We are seeking a person who will lead by example and is a self-motivated team player with strong interpersonal skills.
• May be required to work outside of normal hours if the business dictates.

Education and Experience

• Bachelor's degree, in life sciences, engineering or related field with 10 or more years of experience; Masters degree with 7 or more years of experience; PhD and 2-4 years of experience
• Experience or an affinity for working in a GMP environment.
• Industry experience is preferred.

This is a full-time position reporting to the Head of Process Development and is located in Santa Monica, CA. travel might be required (up to 10%).
The anticipated salary range for candidates who will work in Santa Monica, CA is $170,000 to $201,000. 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.
Note: At this time, Neogene is not sponsoring VISAs.
Neogene Therapeutics requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.
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."