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- Associate Director CGT GMP Quality Operations
We seek a highly skilled and experienced immunologist to lead the CGT operations of the GMP cell and gene therapy unit at IMCPL. The role focuses on ensuring the development and delivery of multiple CGT allogeneic and autologous investigational and commercial products. This position spearheads QA and operations for compliance, control, and efficiency and interfaces with all unit operations to advance the facility's scientific and operational compliance and capabilities.
Education and Experience
Must have PhD in biochemistry, molecular biology, cell biology, virology or microbiology, along with 5+ years of CGT leadership experience with direct reports.
- Must have direct experience hosting and defending FACT inspections for more than minimal manipulation.
- Proven expertise in Cytometry Strategy in one or more therapeutic areas, including autoimmunity, cancer immunotherapy, and hematological oncology, to inform the clinical development of novel personalized medicines and to investigate the molecular pathways of disease to establish the mechanism of action of therapeutics.
- Thorough understanding of disease and drug target biology, creativity and attention to detail, and experience in integrating biomarkers into clinical trials. Demonstrable expertise in directing panel development and analyzing complex multi-modal data sets derived from flow cytometry.
- Proven experience in eQMS implementation, training, and oversight.
- Must have experience leading CGT operations across Quality Units, critical reagent qualification, eligibility testing, apheresis product receipt, drug product ordering, ISBT-128 labeling, final formulation, control rate freezer programs, cryostorage, dose calculations per IND dose levels, infusion package preparation, delivery to the clinic, and clinical outcome assessment.
- High-level experience in analyzing manufacturing data trends, gaps, and improvement opportunities and authoring manufacturing quality summaries for phase-specific clinical development
- Proven experience in analytic strategy and platform development is required. Expertise in developing and qualifying CGT release assays for cell banks, viral vectors, and CGT drug products.
- Proven expertise in developing, executing, analyzing, and reporting long-term and short-term stability studies for CGT products.
- Knowledge of Hematopoietic progenitor cell transplantation principles and practices
- History of developing Master Production Control Records, reviewing executed Batch Process Control Records, and approving/rejecting drug products.
- Experience in compliant and risk-based sampling points for in-process and release testing.
- Experience with PI, IRB, and FDA notification procedures for OOS investigations, and exceptional release is required.
- Experience in handling, investigating, and resolving clinical holds
- Expertise in CMC strategy and regulatory negotiations
- QC supervisor
This position will perform analytical testing and supervise the QC team to support clinical development, qualification, validation, and release testing. Must be an expert in analytical testing, including Flow Cytometry, endonuclease and mycoplasma testing.
Education and Experience
- Bachelor's degree in scientific disciplines such as Biochemistry, Biology or related field
- 5 years of experience in pharmaceutical industry or related industry.
- Proven leadership skills with experience in training and mentoring others within a quality laboratory environment.
- Extensive knowledge of GLP/GMP and quality principles and understanding quality management systems (QMS), regulatory requirements (FDA), and industry standards.
- Possess a strong understanding of QC testing methods, tools, and techniques
- Facility Manager
The Facility Manager plays a crucial role in maintaining a GMP-regulated facility's integrity, compliance, and operational efficiency. This role ensures that all processes and systems related to drug product release remain validated, adhering to current Good Manufacturing Practices (cGMP). The Facility Manager will oversee environmental monitoring, facility control, and equipment management to maintain compliance with corporate and regulatory standards.
Qualifications & Experience
Education
- Bachelor’s degree in a scientific discipline (Biology, Biotechnology, Microbiology, or related field).
Experience
- Minimum of 2 years of experience in a GMP facility environment.
- At least 2 years of experience in equipment management and environmental monitoring within a regulated setting.
- Proficiency in aseptic gowning procedures and cleanroom operations.
- Strong understanding of calibration and validation programs in GMP settings.
Preferred Experience in Cell and Gene Therapy manufacturing or related fields
- Specialty Lab tech (GMP manufacturing)
As a GMP Specialist in Cell Therapy Manufacturing, you will be critical in producing cell-based therapies, working in a GMP-regulated facility. This role supports manufacturing activities from cell culture to product harvesting and cryopreservation, ensuring that high-quality cell therapy products are produced according to Good Manufacturing Practices (cGMP) and standard operating procedures (SOPs). You will collaborate with cross-functional teams to maintain a seamless manufacturing process. This an excellent opportunity to build a career in Cell and Gene Therapy (CGT) drug development.
Education and Experience Requirements
- Bachelor’s degree in biology or a related field with 1-year minimum laboratory experience in molecular cell biology or immunology. The candidate must have demonstratable experience with aseptic techniques and basic analytic techniques.
- Candidates with demonstrable experience in cell and gene therapy manufacturing or working in a controlled GMP environment in academic or industry settings are preferred.
- Senior Specialty Lab Tech (GMP manufacturing)
The role is responsible for manufacturing cell therapy products in compliance with batch records and Standard Operating Procedures (SOPs), ensuring safe, effective, and compliant operations. Essential duties include troubleshooting manufacturing and equipment issues, authoring and revising SOPs, operating automated cell processing equipment, and collaborating across departments to execute GMP production runs.
Education and Experience Requirements
- Associate degree in Biology or Life Science with a minimum of 4 years of experience in Biologics or Cell and Gene Therapy (CGT), OR bachelor’s degree in biology or a related field with at least 2 years of cGMP experience in CGT process development or clinical manufacturing in an industry or academic GMP facility.
- Experience with cell therapy automation technologies, including cell selection, separation, activation, and expansion for autologous and allogeneic product manipulation.
- A strong understanding of biological mechanisms, immunology, and the drug development process.
- Lead Specialty Lab Tech (GMP manufacturing)
The Lead GMP Specialist, executes daily operations within a Cell and Gene Therapy GMP facility. This position involves working with advanced CGT manufacturing processes, ensuring compliance with Good Manufacturing Practices (cGMP), and delivering high-quality clinical-grade CGT products. The role includes troubleshooting issues, training and mentoring junior staff.
Education and Experience Requirements
Education
- Bachelor’s or master’s degree in Life Science with at least 3 years of experience in process development and manufacturing Biologics/CGT products in an Industry or Academic GMP facility OR PhD with 2- years of GMP experience in CGT.
Experience & Skills
- Experience with CGT automation technologies, including cell selection, separation, activation, and expansion for autologous and allogeneic product manipulation.
- Strong understanding of biological mechanisms, immunology, and the drug development process.
- Excellent troubleshooting, problem-solving, and analytical skills.
- Familiarity with batch records and documentation systems.
- Ability to train and mentor junior team members effectively.
- QA Coordinator
We are seeking a Quality Assurance (QA) Coordinator to join our dynamic team specializing in Cell and Gene Therapy (CGT). This role is critical in ensuring the quality and compliance of CGT products across the lifecycle of manufacturing and product release. The ideal candidate will have strong organizational skills, attention to detail, and the ability to collaborate across multidisciplinary teams to support clinical manufacturing and regulatory compliance requirements.
Experience Skills
- Bachelor’s degree in life sciences, biotechnology, or a related field.
- 2 years of experience in quality assurance or CGT manufacturing in a GMP- environment.
- Strong understanding of GMP, FDA, and FACT regulatory requirements.
- Experience with electronic quality management systems (eQMS).
- Excellent written and verbal communication skills.
- Ability to collaborate effectively in a team-oriented environment.
- Preferred Skills
Experience with batch record review in CGT manufacturing. - Knowledge of cell and gene therapy processes and regulatory requirements.
- Familiarity with scheduling tools and inventory management systems
- Document Specialist/Technical Writer
We seek a skilled Document Specialist to join our team in a cutting-edge Cell and Gene Therapy GMP manufacturing environment. The candidate will manage critical documentation processes, ensure compliance with Good Documentation Practices (GDP), and support quality assurance activities related to SOPs, batch records, forms, and regulatory requirements.
Experience Skills
- Bachelor’s degree in a related field (life sciences, technical writing, or regulatory affairs preferred).
- 2+ years of experience in document control, technical writing, or quality systems management in a GMP-regulated environment (preferably cell and gene therapy or biotech).
- Proficiency in using electronic document management systems (EDMS).
- Strong understanding of Good Documentation Practices (GDP) and quality management systems.
- Excellent communication skills, both written and verbal, with a keen attention to detail.
- Ability to manage multiple priorities and meet deadlines in a fast-paced environment.
- Experience supporting regulatory inspections and audits is highly desirable.
Preferred Skills
- Strong organizational skills and the ability to maintain accurate and comprehensive records.
- Proficiency with MS Office (Word, Excel, PowerPoint) and other relevant documentation tools.
- Ability to work collaboratively across teams and departments.