Job Details

Position Overview
Our client is seeking an experienced Senior Scientist or Manager to lead Process Development (PD) and Manufacturing Science & Technology (MSAT) activities for our cell therapy pipeline. This role owns the design, optimization, and scale-up of GMP manufacturing processes, and drives technology transfer from development to clinical manufacturing — including transfer to external Contract Development and Manufacturing Organizations (CDMOs).

The successful candidate will provide technical leadership across process development initiatives, mentor junior scientists and process engineers, and ensure rigorous, well-documented, GMP-compliant workflows — partnering closely with R&D, Manufacturing, Quality, Regulatory, and Clinical teams to advance novel immunotherapy products toward the clinic.

Key Responsibilities
Process Development & Manufacturing
*    Lead the design, optimization, and scale-up of manufacturing processes for new and existing cell therapy products.
*    Lead technology transfer of processes from development to internal GMP manufacturing and to external Contract Development and Manufacturing Organizations (CDMOs), partnering with cross-functional and external teams.
*    Direct feasibility studies and process evaluations to identify the most efficient, cost-effective production methods.
*    Partner with Analytical Development (AD) to establish in-process controls and final release criteria.
*    Develop, review, and maintain SOPs, work instructions, batch records, and process control plans.
*    Drive continuous process improvement initiatives to enhance product quality, yield, and throughput.
*    Ensure all process development and manufacturing activities comply with current Good Manufacturing Practices (cGMP) and other applicable regulatory standards.
Team Leadership & Cross-Functional Collaboration
*    Provide technical mentorship and guidance to process development scientists, engineers, and associates.
*    Represent PD/MSAT in cross-functional meetings, offering technical expertise and strategic recommendations.
*    Collaborate with Quality and Regulatory Affairs to ensure processes and products meet applicable compliance standards.
*    Manage relationships with external partners, suppliers, and CDMOs to coordinate technology transfer, development, and manufacturing activities.
*    Partner with senior management to define project timelines, resource allocation, and program milestones.
Documentation, Reporting & Regulatory Support
*    Prepare and maintain comprehensive process development documentation supporting regulatory submissions.
*    Analyze process and experimental data; deliver reports, presentations, and status updates to stakeholders and leadership.
*    Ensure document control practices are followed and records remain audit-ready at all times.

Required Qualifications
*    M.S. or Ph.D. in Immunology, Bioengineering, Cell Biology, Cancer Biology, Biomedical Sciences, or a related discipline.
*    See Leveling Guidelines below for years-of-experience requirements by degree.
*    Industry experience in biotechnology, cell therapy, or immunotherapy organizations is required.
*    Direct, hands-on cGMP process development and/or manufacturing experience is required.
*    Knowledge of GLP and/or GMP environments and associated documentation practices is required.
*    Demonstrated experience leading technology transfer — including transfer to CDMOs — scale-up/scale-out, and process optimization initiatives in a cell therapy or biologics setting.
*    Working knowledge of process analytics, flow cytometry, potency assays, and statistical data analysis.
*    Experience developing and authoring SOPs, batch records, and regulatory-facing process documentation.
*    Experience authoring technical reports and study protocols is required.
*    Proven ability to manage cross-functional relationships, external partners/vendors, and project timelines.
*    Strong scientific problem-solving, experimental design, and communication skills.
*    Prior experience mentoring or providing technical leadership to junior staff.

Preferred Qualifications
*    Experience with T-cell, NK-cell, macrophage, dendritic cell, or other immune cell-based therapeutic platforms.
*    Experience supporting translational research, IND-enabling studies, or preclinical development programs.
*    Direct people-management experience (performance reviews, hiring, coaching).
*    Experience with assay development, biomarker evaluation, and translational immunology.
*    Experience authoring regulatory support documents or scientific publications.

Salary Range: $110,000-$180,000
*depending on exp