Team Leadership and Management
Build, develop, and manage a high-performing team of process development scientists and engineers
Establish project priorities, resource allocation, and departmental objectives
Foster a collaborative and innovation-driven culture
PPQ & Technology Transfer
Support PPQ activities including but not limited to protocol authoring, batch record authoring and planning
Support technology transfer of cell therapy processes to internal manufacturing sites including make-a-batch assessments and drafting manufacturing batch records
Lifecycle Management
Lead lifecycle management activities for commercial cell therapy products, including process monitoring, continuous improvement, post-approval changes, comparability assessments, and regulatory commitments.
Partner with Manufacturing, Quality, Regulatory Affairs, and Technical Operations to implement process improvements, maintain process control, and support ongoing commercial readiness.
Manufacturing Support & Scientific Deviation Management
Serve as the Process Development and Engineering SME for manufacturing operations, providing scientific support for deviations, investigations, atypical events, and process-related issues.
Lead root cause analyses, impact assessments, and CAPA development using data-driven and risk-based approaches to ensure product quality, compliance, and uninterrupted manufacturing operations.
Regulatory Support
Contributes to authoring and reviewing CMC documentation, including cell therapy process descriptions, characterization summaries, PPQ protocols and reports, and control strategy elements.
Support preparation of BLA/MAA submissions and responses to regulatory questions related to cell therapy manufacturing.
Cross‑Functional Collaboration
Work closely with analytical sciences, quality, regulatory, and manufacturing teams to ensure end‑to‑end process alignment.
Represent cell therapy characterization activities in technical meetings, reviews, and governance discussions.
Required Qualifications
Ph.D. in Chemical Engineering, Biochemical Engineering, Biological Sciences, Biotechnology, Pharmaceutical Sciences, or related discipline with 6+ years of industry experience; or M.S. with 10+ years of relevant experience; or B.S. with 12+ years of relevant experience.
Strong technical expertise in cell therapy process development, GMP operations and late‑stage / commercial readiness.
Experience with late‑stage development, and PPQ for cell therapy processes.
Demonstrated proficiency in applying AI tools and digital solutions to data analysis, documentation, and workflow automation.
Strong technical writing, data analysis, and problem‑solving skills.
Preferred Qualifications
Experience with commercial-stage cell therapy or biologics products.
Experience supporting PPQ, process validation, and post-approval changes.
Familiarity with global regulatory requirements and lifecycle management strategies.
Experience designing and executing DOE and multivariate data analysis for cell therapy processes.
Key Competencies
Strong team management and talent development experience
Excellent cross‑functional communication and collaboration.
Ability to operate effectively in fast‑paced, late‑stage development environments.
Scientific curiosity, ownership mindset, and willingness to support manufacturing operations.
The annual base pay for this position ranges from $138K to $207K. Our positions offer eligibility for multiple incentives an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles. Benefits offered include qualified retirement programs, paid time off (i.e., vacation, holiday, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the applicable plans.
# Hybrid # Cell Therapy
Closing Date 19-Nov-2026 Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.
