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
    • 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
  • 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

 

Director of Manufacturing – FT – Santa Ana, CA

Job Summary

NKMax America is seeking an experienced leader responsible for managing NK cell therapy manufacturing in a pharmaceutical environment.  Also responsible for phase appropriate validation and maintenance of manufacturing equipment in GMP compliance, work with other NKMax sites for method transfers and be accountable for managing manufacturing projects and timelines.  This is a hands-on role responsible for developing, implementing and maintaining GMP systems for a clinical stage cell therapy company.

General Accountabilities

  • Provides functional leadership including hiring and managing a professional, high performing cell therapy manufacturing staff designed to meet the technical and compliance requirements of a growing company.
  • Develop, implement and maintain manufacturing systems.
  • Generate SOPs, batch records, and other manufacturing related documents
  • Manage, investigate, review and/or approve deviations, non-conformances, change controls and CAPAs as required.
  • Partner with Quality to support all quality activities related to the manufacturing and release of clinical product including resolution of investigations and quality issues.
  • Responsible for ensuring that all drug substance and drug product are manufactured in accordance with NKMax’s specifications, in compliance with cGMP and consistent with applicable regulatory filings.
  • Responsible for timely review and release/disposition of cell therapy product and clinical trial supplies.
  • Review and approve IQ/OQ/PQ and validation protocols, tech transfers and reports, as applicable.
  • Monitor the GMP systems currently in place to ensure compliance with documented policies.
  • Develop and implement annual manufacturing plans, departmental goals, action plans, and budgets.
  • Independently report metrics to executive management.
  • Drive continuous improvement utilizing quality tools such as lean, six sigma, and risk management.
  • Internally collaborates with research, clinical, process development, and quality groups.
  • Externally collaborates with contract service providers and corporate partners in support of supply chain objectives.
  • Other duties as assigned.

Job Qualifications and Skills

  • At least 15 years in a technical role manufacturing, QA or product development and at least 10 years in a related management role, leading technical staff.
  • Bachelor’s degree in biological sciences required. Advanced science or engineering degree highly preferred.
  • Education, training, or experience in cell therapy a plus.
  • Lean or Six Sigma certification preferred but not required.
  • Working knowledge of GMP quality systems, regulatory requirements, relevant pharmacopeia and guidance documents.
  • Demonstrated ability to successfully interact with regulatory health authorities at inspections (prior experiencing leading inspections is preferred).
  • Ability to effectively work in a fast-paced, start-up environment, while dealing with ambiguity.
  • Strong attention to detail with the ability to multi-task and handle multiple responsibilities simultaneously.
  • Excellent organizational skills and an ability to prioritize effectively to deliver results within reasonably established timelines.
  • Ability to work independently and as part of a team.
  • Strong interpersonal skills including relationship building, conflict resolution, and verbal and written communication are essential in this collaborative work environment.
  • Candidates must be authorized to work in the U.S.

Quality Control Analyst I – FT – Santa Ana, CA

Job Summary

NKMax America is seeking a Quality Control Analyst to perform analytical testing in a cGMP environment.

General Accountabilities

  • Conduct biological, chemical and physical analyses of raw materials, in-process and final product samples to support manufacturing, validation, process development and stability studies in a GMP environment.
  • Use sophisticated laboratory instrumentation and computer systems to collect and record data (such as LIMS system).
  • Perform assays requiring precise analytical skills and understanding of biology and chemistry principles.
  • Complete testing in a timely and appropriate manner.
  • May maintain inventory/supplies necessary to conduct routine testing
  • Performs equipment maintenance and calibrations as required.
  • Perform aseptic sampling, visual inspection, gowning and working in clean room areas.
  • Review, revise and write test methods, standard operating procedures. In addition to performing QC testing, the Analyst may support validation projects, investigations and method development projects.
  • Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, GLP, QSR and cGMP regulations. Perform release functions in LIMS or other computerized systems.
  • Investigate and write exception (e.g. deviations and OOS) documents.
  • May perform other duties as assigned.

Job Qualifications and Skills

  • Bachelors Degree in Chemistry, or Biological Sciences with Analytical Chemistry or Laboratory coursework, with 2-5 years experience, or Masters Degree in Chemistry, or Biological Sciences, with 0-3 years experience.
  • Working knowledge of GMP quality systems, regulatory requirements, relevant pharmacopeia and guidance documents.
  • Experience with FACS, ELISAs, PCR, FTIR, UV and Fluorescence spectroscopy, and other applicable methods to the testing of biopharmaceuticals.
  • Experience with setting up and successfully managing cell-based assays is highly preferred.
  • Education, training, or experience in cell therapy a plus.
  • Proficient in MS Office, Visio, Project, and statistical software.
  • Ability to effectively work in a fast-paced, start-up environment, while dealing with ambiguity.
  • Strong attention to detail with the ability to multi-task and handle multiple responsibilities simultaneously.
  • Excellent organizational skills and an ability to prioritize effectively to deliver results within reasonably established timelines.
  • Ability to work independently and as part of a team.
  • Strong interpersonal skills including relationship building, conflict resolution, and verbal and written communication are essential in this collaborative work environment.
  • Candidates must be authorized to work in the U.S. and must agree to a background check

Quality Control Analyst II – FT – Santa Ana, CA

Job Summary

NKMax America is seeking a Quality Control Analyst to perform analytical testing in a cGMP environment.

General Accountabilities

  • Conduct biological, chemical and physical analyses of raw materials, in-process and final product samples to support manufacturing, validation, process development and stability studies in a GMP environment.
  • Use sophisticated laboratory instrumentation and computer systems to collect and record data (such as LIMS system).
  • Perform assays requiring precise analytical skills and understanding of biology and chemistry principles.
  • Complete testing in a timely and appropriate manner.
  • May maintain inventory/supplies necessary to conduct routine testing
  • Performs equipment maintenance and calibrations as required.
  • Perform aseptic sampling, visual inspection, gowning and working in clean room areas.
  • Review, revise and write test methods, standard operating procedures. In addition to performing QC testing, the Analyst may support validation projects, investigations and method development projects.
  • Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, GLP, QSR and cGMP regulations. Perform release functions in LIMS or other computerized systems.
  • Investigate and write exception (e.g. deviations and OOS) documents.
  • Provide training to junior staff.
  • May perform other duties as assigned.

Job Qualifications and Skills

  • Bachelors Degree in Chemistry, or Biological Sciences with Analytical Chemistry or Laboratory coursework, with 3-6 years experience, or Masters Degree in Chemistry, or Biological Sciences, with 2-5 years experience.
  • Working knowledge of GMP quality systems, regulatory requirements, relevant pharmacopeia and guidance documents.
  • Experience with FACS, ELISAs, PCR, FTIR, UV and Fluorescence spectroscopy, and other applicable methods to the testing of biopharmaceuticals.
  • Experience with setting up and successfully managing cell-based assays is highly preferred.
  • Education, training, or experience in cell therapy a plus.
  • Proficient in MS Office, Visio, Project, and statistical software.
  • Ability to effectively work in a fast-paced, start-up environment, while dealing with ambiguity.
  • Strong attention to detail with the ability to multi-task and handle multiple responsibilities simultaneously.
  • Excellent organizational skills and an ability to prioritize effectively to deliver results within reasonably established timelines.
  • Ability to work independently and as part of a team.
  • Strong interpersonal skills including relationship building, conflict resolution, and verbal and written communication are essential in this collaborative work environment.
  • Candidates must be authorized to work in the U.S. and agree to a background check

Quality Control Analyst III – FT – Santa Ana, CA

Job Summary

NKMax America is seeking a Quality Control Analyst to perform analytical testing in a cGMP environment.

General Accountabilities

  • Function as lead analyst to assist management in coordination of day to day QC activities.
  • Conduct biological, chemical and physical analyses of raw materials, in-process and final product samples to support manufacturing, validation, process development and stability studies in a GMP environment.
  • Use sophisticated laboratory instrumentation and computer systems to collect and record data (such as LIMS system).
  • Perform assays requiring precise analytical skills and understanding of biology and chemistry principles.
  • Complete testing in a timely and appropriate manner.
  • May maintain inventory/supplies necessary to conduct routine testing
  • Performs equipment maintenance and calibrations as required.
  • Perform aseptic sampling, visual inspection, gowning and working in clean room areas.
  • Review, revise and write test methods, standard operating procedures. In addition to performing QC testing, the Analyst may support validation projects, investigations and method development projects.
  • Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, GLP, QSR and cGMP regulations. Perform release functions in LIMS or other computerized systems.
  • Investigate and write exception (e.g. deviations and OOS) documents.
  • Provide training to junior staff.
  • May perform other duties as assigned.

Job Qualifications and Skills

  • Bachelors Degree in Chemistry, or Biological Sciences with Analytical Chemistry or Laboratory coursework, with 6+ years experience, or Masters Degree in Chemistry, or Biological Sciences, with 5+ years experience.
  • Working knowledge of GMP quality systems, regulatory requirements, relevant pharmacopeia and guidance documents.
  • Experience with FACS, ELISAs, PCR, FTIR, UV and Fluorescence spectroscopy, and other applicable methods to the testing of biopharmaceuticals.
  • Experience with setting up and successfully managing cell-based assays is highly preferred.
  • Education, training, or experience in cell therapy a plus.
  • Proficient in MS Office, Visio, Project, and statistical software.
  • Ability to effectively work in a fast-paced, start-up environment, while dealing with ambiguity.
  • Strong attention to detail with the ability to multi-task and handle multiple responsibilities simultaneously.
  • Excellent organizational skills and an ability to prioritize effectively to deliver results within reasonably established timelines.
  • Ability to work independently and as part of a team.
  • Strong interpersonal skills including relationship building, conflict resolution, and verbal and written communication are essential in this collaborative work environment.
  • Candidates must be authorized to work in the U.S. and agree to a background check

Sales Representative – FT – San Diego, CA

Job Summary

Geographic area: Must reside in San Diego area

  • Actively seek out and engage customer prospects in assigned territory
  • Present, promote and sell NKMax products to new and existing customers
  • Establish, develop and maintain positive customer relationships to ensure future sales
  • Analyze territory market potential, develop sales plan, track sales, and achieve agreed upon sales goals
  • Consistently communicate updates to sales/marketing management regarding sales progress in the field and customer feedback

General Accountabilities

  • Develop and implement a sales plan for generating business and achieving sales goals selling our immune system wellness products
  • Identify leads and actively contact potential customers on a routine basis
  • Maintain consistent contact with potential and existing customers to strengthen relationships and ensure satisfaction with our products
  • Develop and maintain accurate customer and prospect files with complete up-to-date information
  • Analyze and assess customer and territory sales trends.
  • Plan sales activity to meet or exceed assigned monthly, quarterly, and annual sales goals
  • Monitor customer and competitor activity to find potential opportunities
  • Study and stay informed on our products, clinical studies, competitive activity, and other relevant topics that can be used to develop your commercial activity
  • Work closely with Marketing and provide field reports on a regular basis
  • Represent the company at relevant medical conferences and wellness fairs to promote NKMax products
  • Report to management about any product issues, loss or potential loss of key customers, or competitive sales strategies that negatively or positively affect local sales

Job Qualifications & Skills

  • Bachelor’s degree in business administration or related field
  • 2-3 years sales experience in medical offices or related industry required
  • Demonstrated ability to sell medical, diagnostic, laboratory, or health products to physicians or health care professionals
  • Successful track record of effective sales process and deal closures
  • Proficiency with MS Office Suite: Word, Excel, PowerPoint
  • Excellent English communication skills, both written and verbal
  • A proven track record of verifiable sales success driving growth
  • Outstanding influencing, interpersonal and networking skills to drive successful relationship building
  • Effective presentation skills; able to present products and key ideas to customers in a way that fosters understanding and impact
  • Must be willing to travel at least 75% within designated territory
  • Must be able to work independently and successfully manage time and territorory

Position Requirements

  • Creative, independent, strategic thinker capable of developing successful sales strategies
  • Experience in sales planning and execution with success in closing sales
  • Demonstrated ability to effectively communicate product features/benefits to key decision makers
  • Must be flexible, respectful and have a passion to help people obtain optimal health
  • High personal and professional standards of ethics and integrity and a positive “can-do” attitude.
  • Must be personable, friendly, and outgoing for successful relationship building
  • Work independently in the field but also be a team player in terms of consistent communication and collaboration with corporate marketing
  • Must be able roll up your sleeves and build your territory from the ground up within a start-up environment
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