Job Function: Discovery & Pre-Clinical/Clinical Development
Job Sub Function: Biotherapeutics R&D
Job Category:Scientific/Technology
All Job Posting Locations:Spring House, Pennsylvania, United States of America
Job Description:We are searching for the best talent for Experienced Scientist, Biotherapeutics RD to join our team in Spring House, PA.Purpose: The Experienced Scientist Biotherapeutics RD in BioTD CAR-T leads the manufacturing team responsible for producing autologous CAR-T products for Phase 1/2a clinical trials. This role leads on-the-floor clinical cell therapy manufacturing operations in a cGMP environment, ensuring adherence to manufacturing, safety, quality, and regulatory requirements while maintaining production schedules and supporting business goals. The position is responsible for coordinating and troubleshooting manufacturing activities, authoring and reviewing technical documentation and batch records, communicating operational status to stakeholders and management, supporting audits and internal meetings, training new operations staff, and driving continuous improvement initiatives related to safety, environmental, quality, compliance, and process performance.
You will be responsible for:- Support the BioTD CAR-T organization in the manufacturing of CAR-T products for clinical trials.
- Work in a team environment and contribute individually to meet project timelines and objectives.
- Author SOPs and other technical documentation.
- Ensure the manufacturing facility adheres to cGMP manufacturing and safety policies, quality systems, and cGMP requirements while maintaining appropriate environmental control and using proven aseptic techniques.
- Effectively communicate operational status to stakeholders and management.
- Work closely with production staff to troubleshoot process and equipment issues.
- Maintain the production schedule to meet business goals.
- Participate in internal meetings and audits.
- Review batch records and logbooks for completeness and accuracy.
- Successfully complete regulatory and job training requirements, make positive contributions to the organization, and seek opportunities for improvement.
- Identify and implement process improvements related to safety, environmental performance, quality, and compliance within the change control system. Assure regulatory compliance and technical feasibility of proposed changes.
- Conduct training for new operations staff.
- Demonstrate expertise in several areas, including cGMPs, FDA regulations, and sterile/aseptic processing.
- Provides technical support for the investigation and resolution of deviations and atypical events utilizing phase appropriate GMPs.
- Serves as Subject Matter Expert (SME) during internal and external regulatory audits (including FDA, EMA).
Qualifications/Requirements:Education: Minimum of a Bachelor's Degree is required.
- Minimum of 5 years of experience in CAR-T or cell/gene therapy GMP manufacturing using single-use vessels and automated cell processing/expansion equipment.
- Experience leading and/or directing a team of operators to manufacture GMP CAR-T or cell/gene therapy products.
- Experience coordinating manufacturing preparation activities and anticipating future processing needs.
- Knowledge of cGMP regulations, FDA guidance, and other external regulatory authority requirements related to the manufacturing of cell-based products, including ATMPs and Annex 1.
- Experience conducting training for junior operators or new manufacturing staff.
- Experience with Aseptic Processing Simulation.
- Excellent problem-solving skills and the ability to resolve manufacturing issues in real time through coordination with management and QA.
- Excellent communication skills.
- Experience with Microsoft Office software.
- Ability to actively drive innovation, think outside the box, and challenge others to do the same using a risk-based approach.
Prior Experience (preferred):
- Experience with SAP.
- Experience with MES/PAS-X.
- Experience with LIMS.
- Experience leading projects.
- Experience with change control.
#LI-Hybrid
Required Skills: Preferred Skills:Analytical Reasoning, Biochemistry, Chemistry, Manufacturing, and Control (CMC), Coaching, Collaboration, Conducting Experiments, Data Quality, Drug Discovery Development, Molecular Diagnostics, Patent Applications, Pharmacogenetics, Report Writing, Research Documents, Scientific Research, Technologically Savvy, Written Expression
