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Current positions

Senior Process Engineer

Role Summary:

The Process Engineer in the Cell and Gene Therapy (CGT) industry is a critical technical role responsible for the design, development, optimization, scale-up, and continuous improvement of manufacturing processes for life-changing cell and gene therapies. This individual ensures processes are robust, reproducible, scalable, cost-effective, and compliant with cGMP regulations, ultimately enabling the safe and efficient production of high-quality therapeutic products.

Key Responsibilities:

I. Process Design & Development:

• Conceptualization & Feasibility: Collaborate with R&D and clinical teams to translate early-stage scientific discoveries into scalable and manufacturable processes. Conduct feasibility studies and risk assessments for new process technologies.

• Process Definition: Define process parameters, equipment specifications, raw material requirements, and in-process controls for cell and gene therapy manufacturing.

• Unit Operation Design: Design and optimize individual unit operations (e.g., cell culture, cell harvesting, viral vector production, gene editing, purification, formulation, fill/finish) specific to CGT modalities.

• Process Flow & Layout: Develop detailed process flow diagrams (PFDs), piping and instrumentation diagrams (P&IDs), and facility layouts considering unidirectional flow, contamination control, and segregation.

• Equipment Selection & Specification: Research, evaluate, and select appropriate manufacturing equipment, single-use technologies, and automation solutions suitable for CGT production, considering scalability, closed systems, and regulatory compliance.

• Process Modeling & Simulation: Utilize process modeling and simulation tools to predict process behavior, optimize parameters, and identify potential bottlenecks or failure modes.

• Process Intensification: Explore and implement strategies for process intensification to improve yield, reduce footprint, and enhance efficiency.

II. Process Optimization & Scale-Up:

• DoE & Statistical Analysis: Design and execute Design of Experiments (DoE) studies to identify critical process parameters (CPPs) and critical quality attributes (CQAs). Apply statistical analysis to interpret data and optimize processes.

• Scale-Up/Down Strategies: Develop and implement robust scale-up and scale-down strategies to transition processes from lab-scale to clinical and commercial manufacturing, maintaining product quality and yield.

• Troubleshooting & Root Cause Analysis: Lead and participate in troubleshooting activities for process deviations, unexpected results, and manufacturing challenges, performing thorough root cause analysis and implementing effective corrective and preventative actions (CAPAs).

• Yield & Efficiency Improvement: Continuously identify opportunities to improve process yield, reduce manufacturing costs, decrease cycle times, and enhance overall operational efficiency.

• Process Robustness: Implement strategies to enhance process robustness and reduce variability, ensuring consistent product quality.

III. Validation & Qualification:

• Process Validation: Develop and execute process validation protocols (e.g., PPQ – Process Performance Qualification) to demonstrate the consistent and reproducible performance of manufacturing processes.

• Cleaning Validation: Design and oversee cleaning validation studies to ensure equipment is adequately cleaned and free from residues, preventing cross-contamination.

• Equipment Qualification: Support equipment qualification activities (IQ/OQ/PQ) ensuring equipment is installed correctly, operates as intended, and performs reproducibly.

• Aseptic Process Simulation (APS): Participate in and support APS studies for sterile manufacturing processes.

IV. Documentation & Regulatory Compliance (cGMP):

• SOP Development: Author and revise Standard Operating Procedures (SOPs), batch records, and other critical manufacturing documentation.

• Risk Management: Conduct process risk assessments (e.g., FMEAs) to identify and mitigate potential risks to product quality, safety, and regulatory compliance.

• Change Control: Initiate, assess, and manage change controls related to process modifications, equipment changes, and raw material changes.

• Deviation Management: Investigate and document deviations, non-conformances, and out-of-specification (OOS) results, ensuring timely closure and effectiveness of CAPAs.

• Regulatory Submissions: Provide technical support and data for regulatory filings (INDs, BLAs, MAAs) and respond to regulatory agency inquiries.

• Audit Support: Participate in internal and external audits (e.g., FDA, EMA) as a subject matter expert for process-related inquiries.

• Data Integrity: Ensure data integrity throughout all process development and manufacturing activities.

V. Collaboration & Project Management:

• Cross-Functional Teamwork: Collaborate effectively with R&D, Quality Assurance, Quality Control, Manufacturing Operations, Facilities, Supply Chain, and Regulatory Affairs teams.

• Project Leadership: Lead or contribute to cross-functional project teams for new product introductions, process improvements, or technology transfers.

• Technical Transfer: Facilitate the seamless technical transfer of processes between development, clinical, and commercial manufacturing sites.

• Vendor Management: Interface with equipment vendors and service providers to ensure successful project execution and ongoing support.

• Mentorship & Training: Provide technical guidance and training to junior engineers, manufacturing personnel, and other team members.

Qualifications:

• Education: Bachelor’s or Master’s degree in Chemical Engineering, Biochemical Engineering, Bioengineering, or a related scientific discipline.

• Experience: 3-7+ years of experience in process development, process engineering, or manufacturing support within the biotechnology or pharmaceutical industry, with a strong preference for experience in Cell and Gene Therapy (CGT).

• Technical Skills:

  • Strong understanding of aseptic processing and sterile manufacturing principles.

  • Familiarity with cell culture, viral vector production, gene editing technologies (CRISPR, TALENs), and downstream purification techniques relevant to CGT.

  • Proficiency in statistical analysis software (e.g., JMP, Minitab) and DoE methodologies.

  • Experience with process modeling software (preferred).

  • Knowledge of single-use technologies in biopharmaceutical manufacturing.

  • Understanding of automation and process control systems.

• Regulatory Knowledge: In-depth knowledge of cGMP regulations (FDA, EMA, ICH guidelines) applicable to biologics and ATMPs (Advanced Therapy Medicinal Products).

• Soft Skills:

  • Excellent problem-solving and analytical skills.

  • Strong written and verbal communication skills.

  • Ability to work independently and as part of a team in a fast-paced environment.

  • Proactive, results-oriented, and detail-oriented.

  • Adaptability to evolving scientific and regulatory landscapes.

This role requires a highly skilled and adaptable individual who can navigate the unique challenges and rapid advancements within the CGT landscape, contributing significantly to bringing life-saving therapies to patients.

Apply Now

Quality Assurance (QA) Specialist

Role Summary:

A Quality Assurance (QA) Specialist is a pivotal role dedicated to ensuring that products, processes, and systems consistently meet established quality standards and regulatory requirements. This individual acts as a guardian of quality, implementing and upholding the Quality Management System (QMS) to guarantee product safety, efficacy, and compliance, ultimately protecting patient well-being and maintaining the organization’s reputation.

Key Responsibilities:

I. Quality Management System (QMS) Adherence & Improvement:

• SOP Management: Develop, review, approve, and revise Standard Operating Procedures (SOPs), policies, and other QMS documentation to ensure they are current, accurate, and compliant with relevant regulations (e.g., cGMP, ISO).

• Documentation Control: Manage and control essential quality records, ensuring proper archiving, retrieval, and traceability.

• Training: Support and participate in quality-related training programs, ensuring personnel are adequately trained on QMS procedures, regulatory requirements, and their impact on product quality.

• Continuous Improvement: Identify opportunities for QMS process improvements, advocating for and implementing changes that enhance efficiency, compliance, and overall quality.

II. Deviation, CAPA, and Change Control Management:

• Deviation Management: Investigate, document, and manage deviations (non-conformances) from established procedures, specifications, or expectations. This includes performing root cause analysis, assessing impact, and ensuring timely closure.

• Corrective and Preventive Actions (CAPA): Lead or support the development, implementation, and verification of Corrective and Preventive Actions (CAPAs) to address root causes of deviations and prevent recurrence. Monitor CAPA effectiveness.

• Change Control: Initiate, review, assess, and approve change control requests for processes, equipment, materials, or documents, ensuring all changes are thoroughly evaluated for potential quality impact and properly implemented.

III. Batch Review & Release:

• Batch Record Review: Conduct thorough and meticulous reviews of batch records (manufacturing, packaging, testing) to ensure compliance with cGMP, approved procedures, and specifications before product release.

• Product Disposition: Participate in the final product disposition decision, ensuring all quality requirements are met before a product is released to the market or for further processing.

• Material Release: Review and approve the release of raw materials, in-process materials, and finished goods based on specifications and testing results.

IV. Auditing & Inspection Readiness:

• Internal Audits: Conduct or participate in internal audits of manufacturing operations, laboratories, and support functions to assess compliance with QMS requirements and regulatory standards.

• Supplier/Vendor Qualification: Support the qualification and auditing of suppliers and vendors of critical materials and services, ensuring they meet quality standards.

• Inspection Readiness: Prepare the organization for and support regulatory inspections (e.g., FDA, Health Canada, EMA) and customer audits, acting as a Subject Matter Expert (SME) for QA-related topics.

• Audit Response: Assist in developing responses to audit observations and ensuring timely implementation of corrective actions.

V. Quality Oversight & Support:

• Manufacturing Support: Provide direct QA oversight and support to manufacturing operations, ensuring adherence to cGMPs, responding to real-time quality events, and making critical decisions impacting batch quality.

• Laboratory Support: Review and approve laboratory data, test methods, and OOS/OOT (Out-of-Specification/Out-of-Trend) investigations from Quality Control (QC) to ensure data integrity and compliance.

• Validation & Qualification: Review and approve validation and qualification protocols and reports (e.g., IQ, OQ, PQ for equipment; process validation; cleaning validation) to ensure they meet quality and regulatory requirements.

• Risk Management: Participate in quality risk management activities (e.g., FMEAs) to proactively identify, assess, and mitigate risks to product quality.

Qualifications:

• Education: Bachelor’s degree in a scientific discipline (e.g., Chemistry, Biology, Pharmacy, Engineering) or a related field.

• Experience: Typically 2-5+ years of experience in Quality Assurance within a regulated industry (e.g., pharmaceutical, biotechnology, medical device).

• Regulatory Knowledge: Strong understanding of relevant GxP regulations (e.g., cGMP, GLP, GCP), ISO standards (e.g., ISO 9001, ISO 13485), and other applicable industry guidelines.

• Technical Skills:

  • Familiarity with quality tools (e.g., root cause analysis, FMEA, statistical process control).

  • Experience with electronic QMS systems (e.g., Veeva, TrackWise, MasterControl) is often preferred.

  • Proficiency in reviewing technical documents and data.

• Soft Skills:

  • Exceptional attention to detail and strong analytical skills.

  • Excellent written and verbal communication skills.

  • Strong interpersonal skills and the ability to collaborate effectively with cross-functional teams.

  • Ability to work independently, prioritize tasks, and manage multiple projects in a dynamic environment.

  • A high degree of integrity and a commitment to quality.

Apply Now

Role Summary:

The Process Engineer in the Cell and Gene Therapy (CGT) industry is a critical technical role responsible for the design, development, optimization, scale-up, and continuous improvement of manufacturing processes for life-changing cell and gene therapies. This individual ensures processes are robust, reproducible, scalable, cost-effective, and compliant with cGMP regulations, ultimately enabling the safe and efficient production of high-quality therapeutic products.

Key Responsibilities:

I. Process Design & Development:

• Conceptualization & Feasibility: Collaborate with R&D and clinical teams to translate early-stage scientific discoveries into scalable and manufacturable processes. Conduct feasibility studies and risk assessments for new process technologies.

• Process Definition: Define process parameters, equipment specifications, raw material requirements, and in-process controls for cell and gene therapy manufacturing.

• Unit Operation Design: Design and optimize individual unit operations (e.g., cell culture, cell harvesting, viral vector production, gene editing, purification, formulation, fill/finish) specific to CGT modalities.

• Process Flow & Layout: Develop detailed process flow diagrams (PFDs), piping and instrumentation diagrams (P&IDs), and facility layouts considering unidirectional flow, contamination control, and segregation.

• Equipment Selection & Specification: Research, evaluate, and select appropriate manufacturing equipment, single-use technologies, and automation solutions suitable for CGT production, considering scalability, closed systems, and regulatory compliance.

• Process Modeling & Simulation: Utilize process modeling and simulation tools to predict process behavior, optimize parameters, and identify potential bottlenecks or failure modes.

• Process Intensification: Explore and implement strategies for process intensification to improve yield, reduce footprint, and enhance efficiency.

II. Process Optimization & Scale-Up:

• DoE & Statistical Analysis: Design and execute Design of Experiments (DoE) studies to identify critical process parameters (CPPs) and critical quality attributes (CQAs). Apply statistical analysis to interpret data and optimize processes.

• Scale-Up/Down Strategies: Develop and implement robust scale-up and scale-down strategies to transition processes from lab-scale to clinical and commercial manufacturing, maintaining product quality and yield.

• Troubleshooting & Root Cause Analysis: Lead and participate in troubleshooting activities for process deviations, unexpected results, and manufacturing challenges, performing thorough root cause analysis and implementing effective corrective and preventative actions (CAPAs).

• Yield & Efficiency Improvement: Continuously identify opportunities to improve process yield, reduce manufacturing costs, decrease cycle times, and enhance overall operational efficiency.

• Process Robustness: Implement strategies to enhance process robustness and reduce variability, ensuring consistent product quality.

III. Validation & Qualification:

• Process Validation: Develop and execute process validation protocols (e.g., PPQ – Process Performance Qualification) to demonstrate the consistent and reproducible performance of manufacturing processes.

• Cleaning Validation: Design and oversee cleaning validation studies to ensure equipment is adequately cleaned and free from residues, preventing cross-contamination.

• Equipment Qualification: Support equipment qualification activities (IQ/OQ/PQ) ensuring equipment is installed correctly, operates as intended, and performs reproducibly.

• Aseptic Process Simulation (APS): Participate in and support APS studies for sterile manufacturing processes.

IV. Documentation & Regulatory Compliance (cGMP):

• SOP Development: Author and revise Standard Operating Procedures (SOPs), batch records, and other critical manufacturing documentation.

• Risk Management: Conduct process risk assessments (e.g., FMEAs) to identify and mitigate potential risks to product quality, safety, and regulatory compliance.

• Change Control: Initiate, assess, and manage change controls related to process modifications, equipment changes, and raw material changes.

• Deviation Management: Investigate and document deviations, non-conformances, and out-of-specification (OOS) results, ensuring timely closure and effectiveness of CAPAs.

• Regulatory Submissions: Provide technical support and data for regulatory filings (INDs, BLAs, MAAs) and respond to regulatory agency inquiries.

• Audit Support: Participate in internal and external audits (e.g., FDA, EMA) as a subject matter expert for process-related inquiries.

• Data Integrity: Ensure data integrity throughout all process development and manufacturing activities.

V. Collaboration & Project Management:

• Cross-Functional Teamwork: Collaborate effectively with R&D, Quality Assurance, Quality Control, Manufacturing Operations, Facilities, Supply Chain, and Regulatory Affairs teams.

• Project Leadership: Lead or contribute to cross-functional project teams for new product introductions, process improvements, or technology transfers.

• Technical Transfer: Facilitate the seamless technical transfer of processes between development, clinical, and commercial manufacturing sites.

• Vendor Management: Interface with equipment vendors and service providers to ensure successful project execution and ongoing support.

• Mentorship & Training: Provide technical guidance and training to junior engineers, manufacturing personnel, and other team members.

Qualifications:

• Education: Bachelor’s or Master’s degree in Chemical Engineering, Biochemical Engineering, Bioengineering, or a related scientific discipline.

• Experience: 3-7+ years of experience in process development, process engineering, or manufacturing support within the biotechnology or pharmaceutical industry, with a strong preference for experience in Cell and Gene Therapy (CGT).

• Technical Skills:

  • Strong understanding of aseptic processing and sterile manufacturing principles.

  • Familiarity with cell culture, viral vector production, gene editing technologies (CRISPR, TALENs), and downstream purification techniques relevant to CGT.

  • Proficiency in statistical analysis software (e.g., JMP, Minitab) and DoE methodologies.

  • Experience with process modeling software (preferred).

  • Knowledge of single-use technologies in biopharmaceutical manufacturing.

  • Understanding of automation and process control systems.

• Regulatory Knowledge: In-depth knowledge of cGMP regulations (FDA, EMA, ICH guidelines) applicable to biologics and ATMPs (Advanced Therapy Medicinal Products).

• Soft Skills:

  • Excellent problem-solving and analytical skills.

  • Strong written and verbal communication skills.

  • Ability to work independently and as part of a team in a fast-paced environment.

  • Proactive, results-oriented, and detail-oriented.

  • Adaptability to evolving scientific and regulatory landscapes.

This role requires a highly skilled and adaptable individual who can navigate the unique challenges and rapid advancements within the CGT landscape, contributing significantly to bringing life-saving therapies to patients.

Apply Now

Role Summary:

A Quality Assurance (QA) Specialist is a pivotal role dedicated to ensuring that products, processes, and systems consistently meet established quality standards and regulatory requirements. This individual acts as a guardian of quality, implementing and upholding the Quality Management System (QMS) to guarantee product safety, efficacy, and compliance, ultimately protecting patient well-being and maintaining the organization’s reputation.

Key Responsibilities:

I. Quality Management System (QMS) Adherence & Improvement:

• SOP Management: Develop, review, approve, and revise Standard Operating Procedures (SOPs), policies, and other QMS documentation to ensure they are current, accurate, and compliant with relevant regulations (e.g., cGMP, ISO).

• Documentation Control: Manage and control essential quality records, ensuring proper archiving, retrieval, and traceability.

• Training: Support and participate in quality-related training programs, ensuring personnel are adequately trained on QMS procedures, regulatory requirements, and their impact on product quality.

• Continuous Improvement: Identify opportunities for QMS process improvements, advocating for and implementing changes that enhance efficiency, compliance, and overall quality.

II. Deviation, CAPA, and Change Control Management:

• Deviation Management: Investigate, document, and manage deviations (non-conformances) from established procedures, specifications, or expectations. This includes performing root cause analysis, assessing impact, and ensuring timely closure.

• Corrective and Preventive Actions (CAPA): Lead or support the development, implementation, and verification of Corrective and Preventive Actions (CAPAs) to address root causes of deviations and prevent recurrence. Monitor CAPA effectiveness.

• Change Control: Initiate, review, assess, and approve change control requests for processes, equipment, materials, or documents, ensuring all changes are thoroughly evaluated for potential quality impact and properly implemented.

III. Batch Review & Release:

• Batch Record Review: Conduct thorough and meticulous reviews of batch records (manufacturing, packaging, testing) to ensure compliance with cGMP, approved procedures, and specifications before product release.

• Product Disposition: Participate in the final product disposition decision, ensuring all quality requirements are met before a product is released to the market or for further processing.

• Material Release: Review and approve the release of raw materials, in-process materials, and finished goods based on specifications and testing results.

IV. Auditing & Inspection Readiness:

• Internal Audits: Conduct or participate in internal audits of manufacturing operations, laboratories, and support functions to assess compliance with QMS requirements and regulatory standards.

• Supplier/Vendor Qualification: Support the qualification and auditing of suppliers and vendors of critical materials and services, ensuring they meet quality standards.

• Inspection Readiness: Prepare the organization for and support regulatory inspections (e.g., FDA, Health Canada, EMA) and customer audits, acting as a Subject Matter Expert (SME) for QA-related topics.

• Audit Response: Assist in developing responses to audit observations and ensuring timely implementation of corrective actions.

V. Quality Oversight & Support:

• Manufacturing Support: Provide direct QA oversight and support to manufacturing operations, ensuring adherence to cGMPs, responding to real-time quality events, and making critical decisions impacting batch quality.

• Laboratory Support: Review and approve laboratory data, test methods, and OOS/OOT (Out-of-Specification/Out-of-Trend) investigations from Quality Control (QC) to ensure data integrity and compliance.

• Validation & Qualification: Review and approve validation and qualification protocols and reports (e.g., IQ, OQ, PQ for equipment; process validation; cleaning validation) to ensure they meet quality and regulatory requirements.

• Risk Management: Participate in quality risk management activities (e.g., FMEAs) to proactively identify, assess, and mitigate risks to product quality.

Qualifications:

• Education: Bachelor’s degree in a scientific discipline (e.g., Chemistry, Biology, Pharmacy, Engineering) or a related field.

• Experience: Typically 2-5+ years of experience in Quality Assurance within a regulated industry (e.g., pharmaceutical, biotechnology, medical device).

• Regulatory Knowledge: Strong understanding of relevant GxP regulations (e.g., cGMP, GLP, GCP), ISO standards (e.g., ISO 9001, ISO 13485), and other applicable industry guidelines.

• Technical Skills:

  • Familiarity with quality tools (e.g., root cause analysis, FMEA, statistical process control).

  • Experience with electronic QMS systems (e.g., Veeva, TrackWise, MasterControl) is often preferred.

  • Proficiency in reviewing technical documents and data.

• Soft Skills:

  • Exceptional attention to detail and strong analytical skills.

  • Excellent written and verbal communication skills.

  • Strong interpersonal skills and the ability to collaborate effectively with cross-functional teams.

  • Ability to work independently, prioritize tasks, and manage multiple projects in a dynamic environment.

  • A high degree of integrity and a commitment to quality.

Apply Now

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