Accounting Assistant – PT – Santa Ana, CA

Job Summary

The Accounting Assistant will be responsible for working with the Controller to complete all necessary tasks as it relates to the finance of NKMax America.  The ideal candidate will be capable of quickly learning our method system with minimal supervisor. He/She is to possess high organization, understand core accounting principles and stellar in QuickBooks.

The Accounting Assistant will report to the Controller and work with the team to accomplish inter-departmental goals and needs.

General Accountabilities

  • Verify and input all invoices into QuickBooks
  • Provide weekly financial updates to our parent company
  • Prepare, fulfill and distribute any checks requested
  • Request and process W-9 forms via new vendors
  • Approve and process wire transfer requests
  • Scan, file and log accounting documents
  • Reconcile bank and credit card monthly statements

*The company reserves the right to add or change duties at any time.

Skills/Abilities

  • Proficient in QuickBooks
  • High school diploma/GED required
  • Accounting education background highly preferred
  • 2+ years in accounting/bookkeeping (accounts payable preferred)
  • Proficient in Microsoft Office suite and Google Docs
  • Proficient in Windows operating system
  • Advanced written and oral communication skills
  • Flexible schedule up to 20/25 hours per week.

Education/Experience Qualifications

  • Education:  B.S in Accounting or Finance

Cell Therapy Specialist I – FT – Santa Ana, CA

Job Summary

The Cell Therapy Specialist I is part of the NK cell therapy manufacturing team. The position will be expected to support the successful tech transfer and operational readiness process.  The CTS I will use knowledge of cGMP regulations and project management to ensure manufacturing readiness.  Responsibilities of primary importance are to ensure the successful time-sensitive GMP manufacture and release of cell therapy products and promote a culture of quality and compliance.  Ensure all processes and procedures related to operations are in full compliance with cGMP, CFR and site quality systems and company policies.  Upon start of clinical manufacturing the CTS I will be part of a cohesive team responsible for Deviations, CAPAs, Change Controls and is expected to be able to work independently with minimal supervision.

General Accountabilities

  • Performing patient process unit operations and support operations described in standard operating procedures and batch records
  • Accurate and timely completion of documentation required by protocols, standard operating procedures, and batch records.
  • Performing tasks in a manner consistent with safety policies, quality systems, and GMP requirements.
  • Timely completion of training assignments to ensure the necessary technical skills and knowledge
  • Assisting in setting up manufacturing areas and equipment.
  • Writing manufacturing operating procedures that are technically sound, promote effective and efficient operations, and comply with cGMP requirements
  • Routine monitoring of equipment
  • Maintain aseptic technique during processing of products to ensure the integrity, viability and sterility of cellular products until release
  • Must follow special cleaning and gowning procedures for the facility.  Required to work in cleanroom environment requiring specialized gowning such as double gloves, hair net, masks, safety glasses, sterile jumpsuit and shoe covers
  • Perform error free calculations of cell concentrations, dilutions, viabilities during production
  • Must maintain and apply knowledge regarding patient information, screening and testing, labeling and product acceptability and release criteria
  • Be flexible and adaptable to schedule and procedural changes to ensure timely preparation of products with highest quality
  • Maintains current inventory of supplies
  • Other duties as assigned

Job Qualifications

  • Education: Bachelors in relevant science or engineering discipline
  • 1-3 years of experience in a cGMP biologics or cell therapy manufacturing
  • Preferred record of leading and training manufacturing staff
  • Cell culture processing experience in handling and propagation of human primary cell
  • Aseptic processing in ISO 5 biosafety cabinets
  • Universal precautions for handling human derived materials in BSL-2 containment areas
  • Knowledge of cGMP regulations and FDA guidance applicable to biologics and cell therapy
  • Excellent interpersonal, oral and written communication skills. Strong technical writing ability required
  • Ability to work off-shift and long hours as required
  • Ability to lift over 30lbs

Cell Therapy Specialist II – FT – Santa Ana, CA

Job Summary

The Cell Therapy Specialist II is part of the NK cell therapy manufacturing team. The position will be expected to support the successful tech transfer and operational readiness process.  The CTS II will use knowledge of cGMP regulations and project management to ensure manufacturing readiness.  Responsibilities of primary importance are to ensure the successful time-sensitive GMP manufacture and release of cell therapy products and promote a culture of quality and compliance.  Ensure all processes and procedures related to operations are in full compliance with cGMP, CFR and site quality systems and company policies.  Upon start of clinical manufacturing the CTS II will be part of a cohesive team responsible for Deviations, CAPAs, Change Controls and is expected to be able to work independently with minimal supervision.

General Accountabilities

  • Performing patient process unit operations and support operations described in standard operating procedures and batch records
  • Accurate and timely completion of documentation required by protocols, standard operating procedures, and batch records.
  • Performing tasks in a manner consistent with safety policies, quality systems, and GMP requirements.
  • Timely completion of training assignments to ensure the necessary technical skills and knowledge
  • Assisting in setting up manufacturing areas and equipment.
  • Writing manufacturing operating procedures that are technically sound, promote effective and efficient operations, and comply with cGMP requirements
  • Routine monitoring of equipment

Job Qualifications and Skills

  • Education: Bachelors in relevant science or engineering discipline
  • 2-5 years of experience in a cGMP biologics or cell therapy manufacturing
  • Preferred record of leading and training manufacturing staff
  • Cell culture processing experience in handling and propagation of human primary cell
  • Aseptic processing in ISO 5 biosafety cabinets
  • Universal precautions for handling human derived materials in BSL-2 containment areas
  • Knowledge of cGMP regulations and FDA guidance applicable to biologics and cell therapy
  • Excellent interpersonal, oral and written communication skills. Strong technical writing ability required
  • Ability to work off-shift and long hours as required
  • Ability to lift over 30lbs

Cell Therapy Specialist III – FT – Santa Ana, CA

Job Summary

The Cell Therapy Specialist III is a manufacturing subject matter expert (SME) for the NK cell therapy manufacturing process.  The position will be expected to support the successful tech transfer and operational readiness process.  The CTS III will use expert knowledge of cGMP regulations and project management to ensure manufacturing readiness.  Responsibilities of primary importance are to ensure the successful time-sensitive GMP manufacture and release of cell therapy products and promote a culture of quality and compliance.  Ensure all processes and procedures related to operations are in full compliance with cGMP, CFR and site quality systems and company policies.  Upon start of clinical manufacturing the CTS III will be part of a cohesive team responsible for Deviations, CAPAs, Change Controls and is expected to be able to work independently with minimal supervision.

General Accountabilities

  • Performing patient process unit operations and support operations described in standard operating procedures and batch records
  • Accurate and timely completion of documentation required by protocols, standard operating procedures, and batch records.
  • Performing tasks in a manner consistent with safety policies, quality systems, and GMP requirements.
  • Timely completion of training assignments to ensure the necessary technical skills and knowledge
  • Assisting in setting up manufacturing areas and equipment.
  • Writing manufacturing operating procedures that are technically sound, promote effective and efficient operations, and comply with cGMP requirements
  • Work with management to establish and maintain daily unit operations schedule that includes people, product, and material flow across multiple shifts
  • Routine monitoring of equipment
  • Maintain aseptic technique during processing of products to ensure the integrity, viability and sterility of cellular products until release
  • Must follow special cleaning and gowning procedures for the facility.  Required to work in cleanroom environment requiring specialized gowning such as double gloves, hair net, masks, safety glasses, sterile jumpsuit and shoe covers
  • Perform error free calculations of cell concentrations, dilutions, viabilities during production
  • Must maintain and apply knowledge regarding patient information, screening and testing, labeling and product acceptability and release criteria
  • Be flexible and adaptable to schedule and procedural changes to ensure timely preparation of products with highest quality
  • Maintains current inventory of supplies
  • Other duties as assigned

Job Qualifications and Skills

  • Education: Bachelors in relevant science or engineering discipline
  • 5+ years of experience in a cGMP biologics or cell therapy manufacturing
  • Preferred record of leading and training manufacturing staff
  • Cell culture processing experience in handling and propagation of human primary cell
  • Aseptic processing in ISO 5 biosafety cabinets
  • Universal precautions for handling human derived materials in BSL-2 containment areas
  • Knowledge of cGMP regulations and FDA guidance applicable to biologics and cell therapy
  • Excellent interpersonal, oral and written communication skills. Strong technical writing ability required
  • Ability to work off-shift and long hours as required
  • Ability to lift over 30lbs

 

Clinical Laboratory Quality Assurance Manager – FT – Santa Ana, CA

Job Summary

Evaluate, design and implement the lab quality assurance program to ensure that the laboratory is compliant to the regulatory requirements for the continued accreditation and certification of CAP and CLIA.  The Clinical Laboratory Quality Assurance Manager will be responsible for monitoring the Lab Quality Management program, implement new plan for improvement and to meet with updated requirements. This individual will maintain all documents including SOP, policies and forms pertaining to the lab operations.

General Responsibilities

  • Manage the review and development of technical and SOPs, to ensure compliance with appropriate regulations.
  • Utilize root cause analysis to evaluate all systems for correction, recommend action and professionally communicate to management the analysis to continually improve quality.
  • Design, develop and implement new QC procedures.
  • Monitor implementation as designed.
  • Use of metrics, benchmarks and indicators for quality.
  • Responsible for Proficiency Testing scheduling and events.
  • Perform internal audits (CAP interim, competency assessments, quality indicators, periodic audit of QM Plan)
  • Ensure all laboratory activities are performed in accordance to CAP requirements.
  • Maintain all documentation required for licensure purposes.
  • Lead QC staff meetings and discuss findings and recommendations for resolving non-compliance.
  • Demonstrate continuous self-motivated quality development.
  • Proactively take steps to improve quality systems.

Job Qualifications & Skills

  • Education: Bachelor’s Degree required.
  • Experience: 7 years’ experience in quality assurance within CAP/CLIA laboratory environment required.
  • California Clinical Laboratory Scientist License and certified MT/MLS ASCP preferred.
  • Knowledge of word-processing, spreadsheet, and database applications.
  • Knowledge of document control in lab environment
  • Knowledge of CAP/CLIA regulations and guidelines
  • Strong interpersonal skills, verbal and written communication.
  • Effective organization and problem-solving skills.
  • Ability to initiate assigned tasks and to work independently.
  • Capability to manage multiple projects and train.
  • Ability to establish and maintain effective working relationships with coworkers, managers and clients.

Clinical Laboratory Scientist – FT – Santa Ana, CA

Job Summary

Under the direction of Director of Lab Operations, the Clinical Laboratory Scientist (CLS) utilizes professional knowledge, skills and judgment to perform a variety of technical, clerical, physical and quality assurance functions. The CLS provides laboratory specimen testing in compliance to quality requirement. Previous qPCR, molecular, ELISA and flow cytometry experience is highly preferred.

General Accountabilities, demonstrating the ability to perform the following capabilities:

  • Performs high complexity test according to validated protocols and produces accurate laboratory results
  • Performs and document quality control and results analysis
  • Performs proficiency testing accurately and timely
  • Performs and documents maintenance and calibration as scheduled or when needed
  • Follows protocol for testing and reporting controls. Takes appropriate action in out-of-control discrepant or unexpected test results
  • Utilizes Laboratory Information System, accessioning of test order and Specimen Processing
  • Participates in new validation and implementation
  • Performs DNA, RNA extraction, setup RT, qPCR test and results analysis
  • Processes clinical sample and prepare test setup for flow cytometry
  • Performs cell-based assay using various analytical methods
  • Recognizes and resolves problems, troubleshoots malfunctioning equipment
  • Ability to work in a biohazard environment, follows safety policies and standards outlined in the Safety Manual
  • Maintains a neat/clean organized work area and keeps working supplies and reagent inventories
  • Strong interpersonal skills to effectively communication with all employees and clients, while having attention to detail
  • Strong computer skills to accomplish tasks
  • Attentive to record keeping, documentation of work performed and required clerical tasks.
  • Demonstrates the flexibility to adjust schedule in response to test workflow, orders or fluctuations in the workload.
  • Follows up on conflicting or irregular test order problems.

Job Qualifications

Education:

  • BS / BA degree in Science required.

Experience:

  • Three (3) or more years clinical laboratory experience required.

License/Certification:

  • Current California State License for Clinical Laboratory Scientist required.
  • ASCP certification from the American Society for Clinical Pathology preferred.

Skills

  • Excellent skill in Microsoft word, Excel and data analysis
  • Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment

All qualified applicants will receive consideration for employment without regard to race, national origin, religion, age, color, sex, sexual orientation, gender identity, disability, or protected veteran status.

Clinical Laboratory Supervisor – FT – Santa Ana, CA

Job Summary

Under the direction of Director of Lab Operations, the lab supervisor would provide day-to-day supervision of testing schedule and reporting of test results. The clinical Laboratory Supervisor is also responsible for validating and implementing new developed assays according to clinical laboratory protocol. He/she would maintain clinical laboratory quality assurance protocol in compliance to CLIA and CAP regulation and accreditation requirements. In addition, the lab supervisor will assist in establishing new client’s facility setup and continue support to clinical trial projects within the company. The position is best suited for a candidate who can efficiently work in a diverse laboratory environment, goal-oriented laboratory services setting.

 

General Accountabilities, demonstrating the ability to perform the following capabilities:

  • Strong technical background on chemistry, immunophenotyping and molecular assays using various methods including flow cytometry, ELISA, qPCR in clinical laboratory settings.
  • Experience on validate and implement laboratory developed clinical test
  • Establish and maintain clinical laboratory quality assurance protocol
  • Ensure proper performance of laboratory procedures and quality assurance standards
  • Documentation of QA process in relate to all aspects within laboratory
  • Assessment of staff performance and ensure high quality test result with satisfaction turnaround time
  • Provide troubleshooting of laboratory instrumentation and methodologies concerns
  • Interact with vendors and manufacturers regarding technical assistance.
  • Monitor and maintain acceptable levels of analytic performance
  • Provide training and orientation for both licensed and unlicensed lab employees
  • Resolve problems and ensure remedial actions are taken whenever test systems deviate from the laboratory’s established performance specifications.
  • Ensures all procedures and practices of phlebotomy services compliance to blood draw requirements and regulations
  • Coordinates, setup and continue monitor for offsite specimen collection and training at clients’ facilities
  • Maintain satisfaction services to clients in relate to test results and promptly attends to clients concerns and questions.
  • Manage the logistic and pickup schedules for specimen shipping and transportations
  • Identify training needs and assures all lab personnel receive regular in-service training and education appropriate for the type and complexity of the laboratory services performed.
  • Evaluate the competency of all testing personnel and assures the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently.
  • Review worksheets, test results, quality control records, proficiency testing results, and preventive maintenance records.
  • Monitor performance of instrument maintenance and function checks.
  • Assess test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples.
  • Evaluate and document the performance of individuals responsible for high complexity testing at pre-determined interval.
  • Create, reviews and revises Standard Operating Procedures, with periodic updates, to ensure Lab Director review and approval for all new and/or revised procedures.
  • Ensure that QC is within appropriate limits and that all test results are accurate, performing weekly QC reviews as required.
  • Oversee the inventory and ordering of supplies process.
  • Maintain the performance and recording of Proficiency Testing.
  • Manage schedules and maintain complete coverage of all shifts in the laboratory.
  • Perform assessment of the operation of all instruments in areas of responsibility and assign maintenance procedures or repairs as needed.
  • Ensure all lab equipment is always calibrated and functioning effectively.
  • Ensure that the records are organized, neat and readily retrievable.
  • Ensure that all specimens are organized and readily retrievable.
  • Meet target dates and due dates for completion of tasks.
  • Ensure that the lab is organized, neat and clean.
  • Provide back up to any technical or clerical position as needed.
  • Thorough understanding and experience in managing CLIA and CAP laboratory in compliance to regulatory and accreditation requirements
  • Review, implement and monitor lab protocols to ensure continue laboratory operation of high-quality standards
  • Maintain a safe laboratory environment in compliance with OSHA and CLIA regulations
  • Assign priority and CLS functions in the laboratory, performing all analytical procedures, to include specifically:
  • Prepare all solutions, such as, calibrators, etc. either by automation or manual pipetting techniques.
  • Calibrations and Quality Controls
  • Specimen preparations that require dilutions and pipetting techniques
  • Loading samples onto all high complexity testing processes
  • Reviewing, approving and releasing all QC and patient results
  • Troubleshoots problems (client, instrument, computer) as needed.
  • Perform any other duties as assigned by the Director of Laboratory Operations
  • Excellent verbal and written communication skills.
  • Demonstrate critical analysis and complex problem-solving skills.
  • Demonstrate ability to manage highly confidential and proprietary information.
  • Excellent organizational skills
  • Proficient in computer skills that include spreadsheets and word processing software, and Microsoft Office required.
  • Ability to perform complex lab tasks and maintain patient confidentiality.
  • Complies with applicable legal requirements, standards, and procedures including, but not limited to, those within the Compliance Process, Code of Conduct, HIPAA, State, CAP and CLIA.
  • Provides leadership and support for the Compliance process within management area.
  • Ensures timely and accurate reporting and responses to compliance-related issues and assists with implementation of corrective action plans related to such issues.
  • Reports concerns and suspected incidences of non-compliance to Lab Director.
  • Provides open lines of communication regarding compliance issues within management areas and ensure that retaliation against staff who report suspected incidences of non-compliance does not occur.
  • Participates in monitoring and auditing activities and investigations, and implementing quality improvement processes, as required.

NOTE: The above statements are intended to describe the general nature and level of work performed by an employee in this position. They are not intended to be construed as an exhaustive list of all tasks and responsibilities required. All employees may be required to perform duties outside of their normal responsibilities from time-to-time, as needed.

Job Qualifications

  • Education:
    • BS / BA degree in Science required.

    Experience:

    • Minimum eight (8) years of clinical laboratory required.

    License/Certification:

    • Current California State License for Clinical Laboratory Scientist required.
    • ASCP certification from the American Society for Clinical Pathology preferred.

Skills

  • Proficient in Microsoft word and Excel
  • Excellent critical thinking and problem-solving skills
  • Excellent interpersonal, verbal and written communication skills
  • Excellent organizational skills

Clinical Research Associate – FT – Santa Ana, CA

Job Summary

Manages quality controls and the execution of clinical protocol and data management for a number of clinical trials at multiple sites, ensuring compliance with all regulatory and contractual requirements. Establishes and maintains sound clinical and data collection practices to ensure validity of studies. Monitors the conduct and progress of the studies to ensure compliance with established protocols, appropriate research methodology, and study timelines. Participates in protocol development, site/investigator selection, study initiation and termination activities. Develops and completes final study reports.

The ability to travel frequently both domestically and internationally is essential to the role.

General Responsibilities

  1. Participates in the development of the overall clinical plan, drafts protocols, collaborates on statistical analysis plans, and coordinates the protocol review and approval process, to include submissions to regulatory agencies.
  2. Participates in the identification of potential investigators and clinical sites, both nationally and internationally; conducts pre-study site visits, collects and reviews data, and prepares evaluative reports; participates in the final selection of investigators and study sites.
  3. Assists in the identification of contract research organizations and centralized services such as clinical laboratories; assesses qualifications and experience in relation to proposed research activities and participates in final selection.
  4. Oversees research technical and/or administrative staff, to include hiring, training, goal-setting, and distribution of workload.
  5. Assists with the development and implementation of study-specific monitoring and reporting procedures, methods, guidelines, and tools; participates in the establishment of baseline parameters and edit check specifications, and in the development of subject tracking systems.
  6. Conducts clinical trial site initiation visits; advises and trains site personnel on sponsor and regulatory requirements for study conduct; participates and/or conducts site meetings and multicenter investigator meetings and prepares reports.
  7. Conducts site monitoring visits and follow-up to identify significant problems and issues and to ensure that all clinical aspects of studies are being carried out in accordance with state and federal regulations, guidelines and policies.
  8. Reviews on-site files and records, case report forms, and source documents for completeness, accuracy, consistency, and compliance; identifies deficiencies and discrepancies, and provides remedial training and/or initiates corrective action as required.
  9. Ensures appropriate transmission of clinical case data to the data management centers; reviews case report queries and problems and clarifies and/or obtains changes to data as appropriate.
  10. Assists in the termination of clinical studies by identifying items and issues for review and/or follow-up; assembles necessary documents, conducts site termination visits to include test article reconciliation and disposition, review of completeness and accuracy of files, and retrieval of relevant codes and documents; prepares study termination reports.
  11. Performs miscellaneous job-related duties as assigned.

*The company reserves the right to add or change duties at any time.

Skills/Abilities

  • Knowledge of randomized controlled clinical trials principles, methodology, and procedures.
  • Knowledge of all federal and state regulations and guidelines pertaining to the conduct of clinical trials on human subjects.
  • Ability to independently develop novel concepts and techniques in clinical research monitoring.
  • Ability to develop and implement clinical research monitoring plans and standard operating procedures.
  • Knowledge of statistical data collection, editing, validation, and analysis techniques.
  • Knowledge of adverse medical event investigation, analysis, and reporting procedures and standards.
  • Knowledge of the infrastructure and operational characteristics of contract research organizations and centralized clinical laboratories
  • Ability to develop technical reports and manuscripts.
  • Knowledge of current and developing trends and standards in clinical trials monitoring.
  • Ability to make evaluative judgments.
  • Knowledge of industrial standards as applied to good clinical practices.
  • Knowledge of patient care charts and patient histories.
  • Ability to develop and deliver both oral and written presentations.
  • Ability to communicate and interact competently and professionally at all levels within a broad, complex clinical research environment.
  • Ability to establish data collection and management guidelines.
  • Ability to provide technical advice, guidance, and support to professional staff in area of specialty.
  • Ability to supervise and train employees, to include organizing, prioritizing, and scheduling work assignments.

 Education/Experience Qualifications

  • Education: Bachelor’s degree.
  • Experience: At least 2 years of experience directly related to the duties and responsibilities specified.

Document Control Specialist – FT – Santa Ana, CA

Job Summary

NKMax America is seeking a highly motivated individual to join us as a Sr. Document Control Specialist.  Implement quality systems associated with Document Management with a focus on batch record documentation issuance and process enhancements that ensure right first time. This position will report to the SVP Quality and Technical Operations.

General Accountabilities

  • Maintain a document management system compliant with GMP Quality Systems, ICHQ10, and NKMax America requirements.
  • Responsible for the management of all lot documentation and records issuance processes to support clinical and commercial manufacturing.
  • Provides guidance and advice on approved procedures, standardization and requirements associated with the lot document management system.
  • Responsible for enhancing and maintaining the document change control system for batch record issuance and label issuance.
  • Collaborates with cross-functional departments to ensure timely implementation of changes to the batch record and label issuance system.
  • Prints, compiles and issues all lot related documentation (batch records, labels, sample plans, specifications etc.)
  • Investigates deviations against the lot documentation and records issuance system and develops effective corrective action plans.
  • Develops or enhances training content for batch record and label issuance processes and procedures.
  • Provides training to new staff on batch record and label issuance processes and procedures.
  • Quality record owner (deviations, CAPA, CC) associated with batch record and label issuance processes and procedures.
  • Perform other duties as required.

Job Qualifications and Skills

  • Bachelor’s degree and a minimum of 4 years of experience OR Master’s degree and a minimum of 2 years of experience in a quality document management, quality engineering, validation, and quality assurance or quality systems.
  • Strong knowledge of GMP, SOPs and quality system processes.
  • Excellent organizational skills and ability to review processes or procedures.
  • Proficient in MS Word, Excel, Power Point, Adobe Pro, and electronic document management systems (Document Locator, Documentum, Veeva or equivalent).
  • Strong written and verbal communication skills.
  • Ability to communicate and work independently with scientific/technical personnel.
  • Experience in pharmaceutical or bio-pharmaceutical field.
  • Education or training in cell culture and gene therapy manufacturing environment a plus.
  • Quality systems demonstrated working knowledge in areas such as document management, document change control audits, batch record and label issuance.
  • Working knowledge of quality systems and regulatory requirements (21 CRF Part 11/210/211).
  • If required, may occasionally need to work on weekends

Manager, Process Development – FT – Santa Ana, CA

Job Summary

The Manager, Process Development will be responsible for executing a strategic vision to enable successful manufacturing processes and operations of NK cell therapies from early development through clinical and commercial marketing applications.  This position will execute a life cycle approach to Process Development that includes risk and quality-driven product and process understanding, QbD approaches to process design and characterization, and well-defined analytical control strategies.

This individual will be supporting Process Design, Analytical Development, Tech Transfer, Process Validation, Process Comparability, and MSAT. They will deliver on commitments, while maintaining a culture of teamwork, mentorship, scientific rigor, and serving the business needs. This person will be responsible for the PD project portfolio.

The person will be accountable for CMC deliverables including process changes, comparability, process validation, SME support of operations, regulatory submissions, and handoff to clinical and commercial manufacturing teams.

This individual will build strong relationships and interact extensively with Research, Manufacturing, Quality, and Regulatory functions to ensure project milestones and timelines are met.

General Responsibilities

  • Implement and support manufacturing processes that supply clinical trials
    • Receive and adapt early phase processes to accommodate scale, GMP and regulatory requirements, cost, and efficiencies necessary to implement a Phase 1 study
    • Develop and execute manufacturing strategies to meet business needs and project timelines
    • Provide development input to guide potential new pipeline product candidates towards GMP products
  • Update manufacturing processes towards commercial requirements and desired characteristics
    • Conceive, develop, and implement changes that improve cost, labor, or quality of the manufacturing process for products in development or commercial stages
    • Demonstrate appropriate fit for developed manufacturing technologies
    • Design and execute comparability packages supporting the implementation of process changes
  • Provide technical support (MSAT) to clinical manufacturing as well as technology transfer to clinical and commercial facilities including troubleshooting, training, and batch record writing
  • Generate the technical components of cellular immunotherapy process validation packages
    • Support the generation of process characterization data and understanding along with appropriate process control strategy
    • Support the process component of PPQ design and collaborate with manufacturing teams to ensure successful execution
  • Support development, data generation, writing, and editing of CMC sections of regulatory submissions
  • Support strategy and plans in discussion with Regulatory Authorities and consultants
  • Support the suitable study documentation and data verification
  • Supply product of appropriate quality for pre-clinical studies, analytical development, and any other non-clinical needs
  • Maintain and spread knowledge of current scientific literature and leverage key developments

Maintain a culture of mentorship, teamwork, passion for the patient, and scientific rigor

*The company reserves the right to add or change duties at any time.

Skills/Abilities

  • Strong technical qualifications including knowledge and application of process development fundamentals
  • Knowledge of regulatory standards applicable to cellular products, the developing cellular immunotherapy field, and GMPs
  • Extensive cell culture expertise as well as familiarity with underlying NK cell therapy immunobiology and common analytical methods
  • Excellent leadership, communication, writing, and presentation skills

Education/Experience Qualifications

  • Education:  B.S in Biology, Engineering or related discipline with 5+ yrs cell therapy / process development experience