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 SummaryWe are looking for an experienced and experienced professional to join our team as Director, Product Analytical Sciences.
You will manage the leadership and delivery of business-critical projects to support all the analytical aspects related to the late phase of product analytics lifecycle.
As a Director, you will lead a group of scientists for analytical development of multiple cell therapy drug candidates from clinical development through registration. You will represent Analytical Sciences and Development in cross-organizational governance and committees to lead and steer technical and business strategies. You will also lead product characterization, CQA assessment, method optimization, setting scientifically justifiable comparability strategies, specification and control strategies. You will author, review comparability protocols and reports, justification of specifications, and sections of regulatory filings (IND, IMPD), and lead teams to develop business processes and guidelines for coordinated early and late stage analytical development activities to support cell therapy products commercialization, including post-market life cycle management. You will lead and define transfer and comparability studies and characterization strategies to support early and late-phase and post-approval changes. You have expertise in cell therapy flow cytometry and cell-based assays, assay life cycle management and Regulatory requirements. The position is based in Santa Monica, CA and reports to the VP Process Development.
Essential Functions

• Vision in establishing analytical capabilities to support cell therapy products and new modalities.
• Demonstrated organizational and strategic leadership in establishing technical guidelines and business processes, and steering cross-organizational agreement within and outside of cell therapy CMC development.
• Team-oriented and experience in several development stages.
• Experience working with flow cytometry, bioassays and lot release/stability functions to ensure collaborations and integrated process and product development.
• Promote assay life cycle from development through qualification, validation, and assay tech transfer internally and externally.
• Author and review analytical CMC sections with solid datasets to evaluate assay characteristics and ensure regulatory compliance.
• Provide technical support for investigations and troubleshooting, identifying causes and actions for methodological issues and important quality events.
• Manage all aspects of analytical projects performed externally at CROs and CDMOs, ensuring assay technical quality and compliance with laboratory operation SOPs.

Required Abilities

• PhD in Immunology, Oncology, Cell Biology, or related discipline with 8 years of relevant academic or industry experience.
• Established experience in late stage product characterization, regulatory filing, and response to agency questions.
• Experience leading/developing staff members, including both direct reports and skip-level staff.
• Experience in analytical assays and data analysis in different cell-based assays, e.g. multi-color flow cytometry ( 10 colors), live imaging, or ELISA.
• Experience with technical and scientific challenges as applying the novel assays for drug product release from pre-IND to stage products.
• Willingness to occasionally travel for business purposes.

The anticipated salary range for candidates who will work in Santa Monica, CA is $ 190,000 to $230,000. The final salary offered to a successful you are dependent on several factors that may include the type and length of experience in the job type and length of experience within the industry, education.
Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage following the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an "at-will position" and we reserve the right to modify base salary (and any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.
Ready to join our team and make a difference? Apply now!
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 StatementHeadline: 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.”