Manager, Manufacturing Science & Technology (MSAT)

Applied StemCell, Inc.; Milpitas (CA); On-site; USD 150,000 - 200,000; Full time

Job summary

Applied StemCell, Inc. in Milpitas, CA is seeking an experienced Manufacturing Manager with hands-on GMP operation experience to lead cell- and gene-therapy manufacturing efforts. The role combines scientific leadership with process optimization and compliance to cGMP.

You will oversee manufacturing operations, investigations, CAPAs, tech transfer, and cross-functional collaboration to drive quality, yield, and scalability for regulated products.

Qualifications

• Must have hands-on experience with GMP operations in regulated environments.
• Strong track record in cell-based drug product development and manufacturing.
• Proven ability to lead cross-functional teams and drive process improvements.
• Excellent troubleshooting and problem-solving abilities.

Responsibilities

• Serve as technical lead for GMP manufacturing of cell-based and biologic products.
• Provide leadership for manufacturing execution, process troubleshooting, and CAPA.
• Lead investigations of deviations, OOS results, and excursions; implement corrective actions.
• Support development activities to ensure robust, scalable manufacturing processes for clinical production.
• Collaborate with QA, Regulatory, and Tech Transfer during filings and inspections.

Skills

iPSC/stem cell culture

Genome engineering

Analytical skills

Communication skills

Education

PhD in Biology, Cell Biology, Developmental Biology, or related discipline

Job description

Applied StemCell (ASC) is a genome engineering platform company advancing the future of genetic and cell-based medicine through its proprietary TARGATT™ and S-SELeCT™ technologies. These innovations enable safe, scalable, site-specific integration of large payloads with reliable gene expression for the development of next‑generation therapies, both ex vivo and in vivo.

With deep expertise in induced pluripotent stem cells (iPSCs) and cell line engineering, ASC provides end‑to‑end solutions that accelerate innovation across academia and biopharma. Our strong IP foundation and cutting‑edge technologies empower partners to move from concept to clinic with precision, scalability, and confidence. Please visit www.appliedstemcell.com for more information.

Position Overview

Applied StemCell is seeking an experienced and highly motivated Manufacturing Manager with hands‑on GMP operation experience to provide technical leadership supporting the development and GMP manufacturing of advanced cell and gene therapy products.

. The successful candidate will lead manufacturing operations, process optimization, , manufacturing investigations, and continuous improvement initiatives while ensuring manufacturing processes remain scientifically sound, scalable, and compliant with current Good Manufacturing Practices (cGMP).

The ideal candidate combines strong scientific expertise in molecular and cellular biology with hands‑on experience supporting regulated manufacturing environments and drug product development.

Key Responsibilities

Manufacturing Science & Technical Operations

• Serve as the primary technical resource supporting GMP manufacturing operations for cell‑based and biologic products.
• Provide scientific leadership for manufacturing execution, process troubleshooting, and technical problem solving.
• Evaluate manufacturing performance and implement process improvements to improve quality, efficiency, yield, and scalability.
• Lead investigations involving manufacturing deviations, out‑of‑specification (OOS) results, and process excursions.
• Perform root cause analyses and develop effective CAPAs.
• Drive operational excellence initiatives utilizing scientific and data‑driven approaches.

Drug Product Development

• Provide technical leadership supporting development of cell‑based drug products including formulation, cryopreservation, storage, thawing, fill‑finish, and shipping strategies.
• Collaborate with Development teams to ensure manufacturing processes are robust, scalable, and suitable for clinical production.
• Support Chemistry, Manufacturing and Controls (CMC) activities for regulatory submissions.
• Contribute to manufacturing sections of IND, regulatory filings, client technical packages, and manufacturing documentation.

Cell Therapy & Advanced Manufacturing

• Support manufacturing processes involving:
• Induced pluripotent stem cells (iPSCs)
• Genome engineered cell lines
• Cell banking and characterization
• Exosome manufacturing and purification
• Cell expansion and harvesting
• Aseptic processing
• Cryopreservation and cold‑chain management
• Evaluate emerging manufacturing technologies to improve process robustness and scalability.

GMP Compliance & Quality Systems

• Ensure manufacturing activities comply with FDA, ICH, USP, and cGMP requirements.
• Experience with reviewing:
• SOPs
• Manufacturing Batch Records
• Process Validation Protocols
• Technical Reports
• Change Controls
• Support client audits, internal audits, and regulatory inspections.
• Maintain manufacturing inspection readiness in partnership with Quality Assurance.
• Identify opportunities to improve manufacturing processes, automation, and operational efficiency.
• Evaluate and implement new manufacturing technologies and equipment that enhance scalability and product quality.
• Support facility expansion, equipment selection, and manufacturing capacity planning.
• Assist Business Development teams by providing technical expertise during customer discussions, proposal development, and manufacturing feasibility assessments.
• Stay current with emerging trends in cell therapy, genome engineering, exosome manufacturing, and advanced bioprocessing technologies to support ASC's strategic growth.

Cross‑Functional Leadership

• Collaborate with Manufacturing, Research, Process Development, Quality Assurance, Quality Control, Supply Chain, Regulatory Affairs, Project Management, and Business Development.
• Provide technical expertise during customer meetings and manufacturing planning discussions.
• Support new product introductions and commercial manufacturing readiness.
• Mentor manufacturing scientists and technical staff while promoting continuous improvement and GMP best practices.

Essential Qualifications

• Deep expertise and hands‑on experience in iPSC/stem cell culture with proven track records.
• Working knowledge and hands‑on experience with genome engineering technology and workflow.
• Excellent analytical, troubleshooting, and problem‑solving abilities.
• Strong communication skills with the ability to effectively collaborate across scientific, manufacturing, quality, and commercial teams.

Desired Qualifications

• Over 2 years of experience in GMP operations within biotechnology or pharmaceutical industries.
• Demonstrated experience working in regulated GMP manufacturing environments.
• Hands‑on experience supporting drug product development and manufacturing process development.
• Experience with technology transfer from development into manufacturing.
• Experience supporting process validation, engineering runs, manufacturing investigations, and process optimization.
• Working knowledge of FDA cGMP regulations, ICH guidance, and pharmaceutical quality systems.
• Experience supporting cell therapy, gene therapy, stem cell, biologics, or advanced therapy manufacturing strongly preferred.

Technical Skills

The successful candidate will possess expertise in the following areas:

• Cell & Molecular Biology – Strong scientific foundation in mammalian cell culture, iPSC technologies, genome engineering, biologics, and advanced cell‑based manufacturing.
• GMP Manufacturing – Experience supporting drug product development, , manufacturing scale‑up, and continuous improvement within GMP‑regulated environments.
• Quality Systems & Technical Leadership – Working knowledge of cGMP regulations, manufacturing investigations, CAPA, change control, technical documentation, and the ability to lead cross‑functional teams in resolving complex manufacturing challenges.

Education

• PhD in Biology, Cell Biology, Developmental Biology, or related discipline required

This job description in no way states or implies that these are the only duties to be performed by this employee.He or she will be required to follow any other instructions and perform any other duties requested by his or her supervisor or the management of the company.