Principal Scientist - Fill Finish and Single-Use Systems

Role Summary

Lead the design and selection of single-use systems (SUS) suitable for the transition from development to commercial drug product manufacturing. Provide strategic direction to development teams on SUS technology selection and implementation to develop next-generation processes and technologies for manufacturing and cryopreserving adoptive T-cell therapies. Ensure compliant design, qualification, and lifecycle management of SUS used in drug product manufacturing, formulation, sterile filtration, and filling operations. Apply hands-on technical depth and regulatory filing/validation experience in a large-scale biopharma or CDMO environment.

Responsibilities

• Serve as a subject matter expert for aseptic fill finish operations including automated and semi-automated filling and sealing of bags and vials and support for filling line design, validation, and troubleshooting.
• Serve as development leader of SUS design, specification, and qualification for all DP unit operations in the clinical/pre-pivotal space, and provide technical training and mentorship to process engineers and validation staff.
• Partner with suppliers to evaluate product contact materials for adsorption, extractables/leachables, particulates, and compatibility with process, sterilization validation, and system integrity performance.
• Author and review technical documents including user requirement specifications, design qualification, IQ/OQ/PQ protocols, risk assessments, and tech transfer packages.
• Support supplier audits, regulatory audits, change controls, investigations, and CAPAs for SUS components impacting GMP manufacturing.
• Maintain awareness of emerging industry standards, regulatory expectations, and vendor technologies in fill finish and single-use systems.

Qualifications

• PhD in Chemical or Mechanical Engineering, Life Sciences, Materials Sciences, or related discipline with 3-5 years of industry experience preferred
• or BS/MS with equivalent experience in regulated biopharmaceutical manufacturing, MSAT, or validation engineering
• Excellent communication and interpersonal skills, including externally client facing as the single point of contact with suppliers to communicate user requirements and provide guidance to address gaps in supplier capabilities and/or technologies
• Expertise in small batch fill/finish process development including single use kit design, primary container selection and design, filling parameter optimization, sealing parameter optimization, access devices and clinical administration options
• Expertise in fill/finish testing methods including sterile filtration validation, residual seal force, and container closure integrity testing to meet USP standards
• Experience in polymer/material science or polymer manufacturing to inform materials risk assessments
• Familiar with Cell Therapy SUS sub-components (e.g., hose barbs, boat ports, oetiker clamps, etc.), and material types (e.g., Tepoflex (TPE), silicone, PVC, fluoropolymers, polyethylene (PE), etc.) and characteristics of these plastics and polymers including biocompatibility, process suitability, extractables/leachables, and connections to enable aseptic processing
• Working knowledge of single-use and consumable compliance standards including ASTM F-2097, USP, ISO 11137, ISO 11737, ICH Q9, and USP Annex 1
• Understanding of the regulatory and compliance requirements for raw materials and SUS/SUT used in CGT manufacturing
• Strong understanding of cGMP principles, 21 CFR and ICH Guideline compliance
• Self-motivated individual with demonstrated ability to lead and support highly cross-functional teams
• Demonstrated ability to analyze technical data and support the design of experiments
• Strong documentation skills including authorship of technical reports and regulatory submissions

Skills

• Strong technical leadership in aseptic fill finish and SUS design
• Regulatory filing and validation execution experience in biopharma/CDMO environments
• Process development and qualification for single-use systems
• Material science and extractables/leachables risk assessment
• Strong communication and collaboration across suppliers, internal teams, and external auditors

Education

• PhD in Chemical or Mechanical Engineering, Life Sciences, Materials Sciences, or related discipline (preferred) or BS/MS with equivalent experience