Marker Therapeutics, Inc.

Careers

Available Positions

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Clinical Quality Assurance Manager / Director

The Clinical Quality Assurance Manager / Director will join a newly formed Quality team and report directly to VP of Quality. This person is responsible for assuring the quality of clinical development systems, processes and related activities. This position plays a lead role within Marker’s GCP QA process, works closely across Marker Quality, Regulatory and Clinical teams to ensure that ongoing clinical trials meet global regulatory and business requirements. This position represents the company both internally and externally. Lastly, the position helps to drive a ‘culture of quality’ at Marker.

Position Responsibilities

  • Develop, lead, implement and maintain Marker’s GCP QA audit program to support aspects of Phase I-IV US-based clinical trial.
  • Lead qualification, routine and for-cause audits of Clinical Research Organizations (CRO), investigator sites, laboratory and data management vendors as well as other clinical vendors to assess effectiveness of their QMS and compliance to approved clinical study protocols and contracts.
  • Conduct Clinical Study Report (CSR) and Trial Master File (TMF) audits.
  • Maintain the approved supplier list (ASL) for Clinical suppliers.
  • Ensure timely issuance of audit reports, audit observations, oversee audit response process and drive audits to closure. Evaluate audit observation trends and escalate as required to Quality, Regulatory and Clinical Departments Heads.
  • Prepare and lead the cross functional site Quality Management Review (QMR) meetings
  • Prepare Quality Agreements for review and approval by Quality, Clinical and Regulatory Departments Heads.
  • Ensures all CRO’s operate in a state of quality compliance.
  • Ensures Deviation and Change Management Processes are utilized to manage quality events that impact on delivery of accurate and consistent Dossiers and submissions.
  • Quality approval of Clinical Research Organizations and supporting suppliers for the delivery of Clinical Trial activities.
  • Management of documentation flow for Clinical QA activities with above providers including change management, deviations and non-conformance.
  • Lead/support continuous improvement activities and conduct internal training on Clinical Quality standards and regulations.
  • Ensure quality incidents are fully investigated, root cause analysis is defined and that CAPA has been implemented and monitored for effectiveness. Provide data to assess risks, quality metrics and CAPA learnings at applicable QMR.
  • Perform Quality Documents Review (e. g SOPs, instructions).
  • Maintaining current working knowledge of regulations that may have impact on role.
  • Other duties as assigned.

Skills, Education and Experience Required

  • Minimum BA/BS degree in, preferably, biological sciences, or related field
  • Seven or more years of industry (Pharmaceutical, Cell and Gene Therapy, Medical Devices) experience and strong experience in Clinical Quality auditing.
  • Thorough understanding of international guidelines (ICH, cGCP) including study conduct, statistics and data management.
  • Demonstrated ability to analyze laws, regulations, and guidelines and apply them in practice.
  • Demonstrated ability in using continuous improvement techniques to contribute to a pharmaceutical QMS (e.g. Root Cause Analysis, etc.)
  • Excellent verbal and written communication skills and the ability to interact professionally with a diverse group of stakeholders, senior managers, and subject matter experts.
  • Strong analytical, project management skills.
  • Experience with eDocument Management, Training, CAPA’s, Audit systems and tools.

To apply, please submit your CV to HR@markertherapeutics.com.

Consultant Medical Monitor

Marker Therapeutics is seeking a consultant medical monitor. Qualified candidates must have a medical doctorate (MD) with a background in oncology (board eligibility in oncology and/or hematology preferred). Please contact Mythili Koneru at mkoneru@markertherapeutics.com with CV or for further information.

Manufacturing Technician

Marker Therapeutics is seeking a technician for its manufacturing group to support its ongoing efforts to develop immunotherapies for the benefit of patients with cancer. This position will work under the guidance of the Senior Director of CMC and perform assigned responsibilities to support the company’s product manufacturing process and process improvement initiatives.

Depending on previous experience and qualifications, this individual will be expected to either lead or support the manufacturing process and process characterization of scale-up/scale-down cell manufacturing processes, including optimizing process parameters, cell concentrations and therapeutic product fill and finish technologies to advance our therapeutic programs. The successful candidate must be a team player with strong expertise in GMP manufacturing and must have the ability to communicate and collaborate within an interdisciplinary environment.

To support the company’s vision, mission and values by demonstrating: excellence, competence, collaboration, respect and commitment to our community with accountability.

General and Technical:

  • Demonstrated ability to work collaboratively as a member of a project team and to communicate effectively with colleagues.
  • Strong working knowledge of GTP, GMP, and GLP guidelines, including direct experience in GMP manufacturing and/or process improvement in the Biotech/Pharmaceutical industries.
  • Strong working knowledge of aseptic techniques, cell culture techniques, bioanalytical assays, and an understanding of basic cellular biology
  • Working knowledge of the scientific and technical aspects of T-cell culture is desirable
  • Effective oral and written communication skills.
  • Ability to work well under pressure and meet critical timelines.
  • Demonstrated knowledge and application of pertinent or comparable computer programs, as well as working knowledge of MS Office programs (e.g. Excel, Word).Must be able to remain in a stationary position 50% of the time
  • The person in this position will often need to move about inside the laboratory and office to access machinery, equipment and files
  • Needs to operate a computer and other laboratory equipment with dexterity
  • Must be able to exchange accurate information with colleagues as much teamwork is required
  • Must be able to observe and assess assay results

Responsibilities:

  • Perform aseptic cell growth and manipulation procedures, such as cell isolation or enrichment, culture, cryopreservation and cell product thaw/wash.
  • Perform error-free calculations to determine cell viability, dilutions, and cell concentrations.
  • Demonstrate ability to identify issues, offer alternatives, and implement newly recognized courses of action as determined by the team.
  • Implement and maintain procedures to ensure compliance with company quality systems, safety systems and technical excellence.
  • Maintain comprehensive records of all work.
  • Provide regular updates, data, and applicable documentation to the project team.
  • Perform procedures and maintain accurate documentation in compliance with FDA’s Good Laboratory Practices as well as familiarity with Good Manufacturing Practices.
  • Prepare and participate in technology transfers to CMOs and contract testing laboratories.
  • Works under minimal supervision. Needs to attend to details and be able to work independently after the initial training.
  • Oversees the maintenance of lab equipment and environment, orders laboratory supplies and equipment as needed.
  • Participate in the preparation of CMC sections for regulatory submissions (IND, Annual Reports, and BLA), invention disclosures, progress reports, and publications.
  • Communicate research and development findings with internal and external partners.
  • Other related duties may be assigned to meet business/corporate needs.

Minimal Experience and Skills:

  • BS, MS in Biology or a related science with 5+ years of relevant industry/academia experience.
  • Ph.D. in Biology or a related science with 2+ years of relevant industry/academia experience.
  • Expertise in process development and process characterization of scale-up/scale-down cell manufacturing processes, including optimizing process parameters, cell concentrations and therapeutic product fill and finish required.
  • Experience with T cell-based therapies preferred.
  • Cell culture experience is essential.
  • Specific experience working with T cells/ immunology would be highly beneficial.
  • Attention to detail, ability to problem-solve, manage workflow, meet deadlines, communicate and work in a fast-paced team environment required.

To apply, please submit your CV to HR@markertherapeutics.com

Quality Assurance Specialist – Validation

As Quality Assurance Validation Specialist you will be joining a newly formed team where working together focused on saving lives by finding the cure for cancer is a daily activity.

This position will provide QA support and technical review of protocols/reports related to qualification and validation of facilities, equipment, analytical methods, manufacturing process, etc., to ensure compliance with applicable cGMP regulations, corporate policies and site SOPs. This position reports to the Senior Manager of  Quality Assurance.

You will work closely with various departments in the design and development of validation protocols to ensure the purpose, testing and intended outcomes are defined and are in compliance with the Validation Master Plan, applicable GMP and regulatory requirements.

The candidate is proficient in communication (written and verbal), multitasks across multiple functional areas, is timeline focused and flexible in in their work scheduling to meet the demands of a multi-product clinical phase gene therapy company.

Position Responsibilities

  • Participate in validation activities to ensure protocols, qualifications and reports meet industry best practices and are archived and retrievable.
  • Provide QA support in the development, review and execution of internal validation / qualification documentation.
  • Ensure equipment, analytical methods and manufacturing processes are qualified/validated to required standards through review of qualification documents / protocols.
  • Actively assist in the development of validation file structure, documents and records as required by relevant regulatory guidance’s.
  • Ability to walk down and verify system drawings (i.e., P&IDs, as-builts, etc)
  • Ability to interpret and relate validation standards for implementation and review to functional areas.
  • Ability to support the implementation of new policies and procedures issued by Quality Systems.
  • Duties and responsibilities may include providing QA validation oversight of facilities (Internal/External), utilities, laboratory and manufacturing equipment as applicable.
  • Participate in continuous quality system improvement.
  • Support other duties as requested by management.
  • Availability to work on weekends or in rotating shifts.
  • Perform other duties as assigned.

Skills, Education and Experience Required

  • Bachelor’s Degree in biological sciences, or related discipline
  • Minimum of 2 to 3 years within Quality Assurance in a cGMP regulated Biologics or Pharmaceutical environment with direct experience in process, equipment, analytical method, utilities and facility validation.
  • General knowledge and understanding of pharmaceutical Design/Build/Commission/Validation processes and how they relate to US regulatory requirements and cGMP regulations.
  • Experience in writing and execution of IQ, OQ and PQ protocols and reports for GMP Facilities, Equipment, Systems and Software.
  • Previous validation protocol technical review experience.
  • Working knowledge of lab equipment, test method, process, and facility validation in a regulated environment.
  • Ability to review and interpret scientific data and ability to apply statistical tools (Grubbs, Student Test, Chi-Square).
  • Knowledge of Validation Lifecycle Approach.
  • Demonstrated ability to manage multiple activities while maintaining a high level of organization.
  • Demonstrated strong problem solving and analytical skills.
  • Excellent communicator, both verbal and written
  • Ability to read and interpret validation/engineering documents (protocols and reports).
  • Ability to work both independently without supervision and be a part of a team, demonstrating excellent communication and interpersonal skills.
  • Ability to effectively plan and organize work activities and prioritize task completion to meet schedules and deadlines.
  • Strong problem solving and analytical skills with demonstrated ability to be detail oriented; while managing multiple projects simultaneously.
  • Ability to gown and gain entry to manufacturing areas

To apply, please submit your CV to HR@markertherapeutics.com.

Quality Control Manager

The Quality Control Manager will join a newly formed Quality team and report directly to VP of Quality. This position would give you the opportunity to help shape a whole quality function from the ground up as well as being a key figure in day-to-day operations. The QC Manager would be a key member of the site quality team. This person will be responsible for the set-up of a brand-new Quality Control (QC) Cell Therapy laboratory and its management. Also, the manager will collaborate with R&D on a successful transfer of analytical methods to QC. The QC Manager will be performing Cell Biology, Biochemistry, and Safety assays in support of the production, product release, and distribution of Cell Therapy products.

This position plays a lead role within Marker’s GMP process, works closely across Marker Quality, Manufacturing, Research and Development and Regulatory teams to ensure that ongoing clinical trials meet global regulatory and business requirements. This position represents the company both internally and externally. Lastly, the position helps to drive a ‘culture of quality’ at Marker.

Position Responsibilities

  • Assists in the start-up of the QC laboratory by authoring/approving User Required Specifications, Standard Operating Procedures (SOPs), Validation and Qualification Protocols, equipment purchasing, and Laboratory Process Flow
  • Manages QC Department, including staffing and laboratory activities
  • Provides training and leadership to the QC personnel
  • Develops QC department protocols and procedures for operation (analytical, equipment, risk management, OOS investigations, etc.)
  • Manages all day-to-day functions and initiatives regarding final drug product testing, release testing of raw materials, stability program and equipment PM, ensuring that Standard Operating Procedures (SOPs), current Good Manufacturing Practices (GMPs) and all other regulatory requirements are followed
  • Manages and executes analytical method validation and equipment and software qualification
  • Executes and approves laboratory investigations, deviations, and resolves discrepancies in product testing
  • Develops and conducts departmental cGMP and SOP training program in coordination with QA Manager
  • Demonstrates technical proficiency in analytical methodology (flow cytometry, ELISA, ELISpot, cell counting, PCR-based assays), microbiological methods and adherence to GMP and ICH compliance and/or conformance
  • Represents QC on cross-functional project teams
  • Ensures that team objectives align with key Company strategic goals and programs
  • Successfully manages and meets agreed upon milestones for key Company projects
  • Oversees the completion of projects through the development and approval of schedules, project plans, master plans, protocols and reports
  • Oversees shipment and testing of analytical samples contracted to CTOs
  • Responsible for transferring new product support methods/instrumentation and procedures from research-oriented departments to the compliance environment
  • Maintains current working knowledge of regulations that may have impact on role
  • Other duties as assigned

Skills, Education and Experience Required

  • Minimum Bachelor’s degree in Biological Sciences, Biotechnology or a related field (Master’s degree is preferred)
  • Minimum of 5 years of experience in an aseptic manufacturing environment (cell and gene therapy), preferably with experience in a Quality organization (e.g. Quality Lead or Manager)
  • Proven ability to lead, coach, and motivate employees, clearly communicate job requirements and effectively manage performance of assigned staff
  • Strong knowledge of cell therapy analytical methods (flow cytometry is a must)
  • Previous experience working with non-conformances, and corrective action and preventive action processes
  • Experience writing and reviewing technical documentation
  • Ability to work both independently without supervision and be a part of a team, demonstrating excellent communication skills
  • Strong problem solving and analytical skills with demonstrated ability to manage a number of projects simultaneously is a must
  • Knowledge of Six Sigma Lean principles and continuous improvement
  • Must have excellent oral, written and interpersonal skills, are required
  • Ability to effectively plan and organize work activities and prioritize task completion to adhere to schedules and deadlines
  • Extensive knowledge of cGMP, ICH and FDA compliance

To apply, please submit your CV to HR@markertherapeutics.com.

Scientist/Research Associate – Assay Development

Marker Therapeutics is seeking a Scientist or Research Associate in its Assay Development group to support its ongoing efforts to develop immunotherapies for the benefit of patients with cancer. Depending on previous experience and qualifications, this individual will be expected to either lead or support the identification, development and optimization of cell-based assays to advance our therapeutic programs. The successful candidate must be able to work independently but also be a team player with strong expertise in assay development and must have the ability to communicate and collaborate within an interdisciplinary environment. Expertise in immunology/cancer biology/molecular biology preferred.

Responsibilities:

  • Develop cell-based methods for characterization of specific relevant end-points for therapeutic programs.
  • Possess strong experience with immunological techniques, including multi-parameter flow cytometry and ELISpot.
  • Perform initial reagent validation in relevant cell-based assays.
  • Design, implement and troubleshoot experiments, both independently and in collaboration with colleagues, to reach desired goals.
  • Develop SOPs and worksheets
  • Write reports for regulatory bodies
  • Interact with vendors and other biotechnology companies
  • Communicate with group leaders and other technologists
  • Read and stay current with pertinent scientific literature
  • Prepare and facilitate the transfer of the above assays to internal and/or external groups.
  • Communicate research and development findings to internal and external partners.

Minimal Experience and Skills:

  • BS, MS in Biology or a related science with 5+ years of relevant industry/academia experience.
  • Ph.D. in Biology or a related science with 2+ years of relevant industry/academia experience.
  • Expertise in assay and reagent development, optimization, validation and standardization required.
  • Experience with T cell-based therapies preferred.
  • Experience in tissue culture and propagation of primary human cells
  • Attention to detail, ability to problem-solve, manage workflow, meet deadlines, communicate and work in a fast-paced team environment required.

To apply, please submit your CV to HR@markertherapeutics.com.

Scientist/Research Associate – Immune Monitoring

Marker Therapeutics is seeking a Scientist or Research Associate in its Immune Monitoring group to support its ongoing efforts to develop immunotherapies for the benefit of patients with cancer. Depending on previous experience and qualifications, this individual will be expected to either lead or support the development of immune monitoring assays to advance our therapeutic programs. The successful candidate must be a team player with strong expertise in immune monitoring and must have the ability to communicate and collaborate within an interdisciplinary environment.

Responsibilities:

  • Process and store blood and plasma/serum samples
  • Design and perform Immune monitoring assays (e.g. multi-parameter flow cytometry, ELISpot, ELISAs, Luminex array).
  • Purify and characterize peripheral blood mononuclear cells (PBMCs) and/or tumor-infiltrating lymphocytes (TILs).
  • Evaluate T cell receptor sequences in PBMCs and/or TILs.
  • Implement bioinformatic strategies for data analysis
  • Design, implement and troubleshoot experiments, both independently and in collaboration with colleagues, to reach desired goals.
  • Develop SOPs and worksheets
  • Communicate research and development findings with internal and external partners

Minimal Experience and Skills:

  • BS, MS in Biology or a related science with 5+ years of relevant industry/academia experience.
  • Ph.D. in Biology or a related science with 2+ years of relevant industry/academia experience.
  • Expertise in Immune monitoring assays development, validation and standardization required.
  • Experience in tissue culture and propagation of primary human cells
  • Experience with T cell-based therapies preferred.
  • Attention to detail, ability to problem-solve, manage workflow, meet deadlines, communicate and work in a fast-paced team environment required.

To apply, please submit your CV to HR@markertherapeutics.com.

Scientist/Research Associate – Process Development

Marker Therapeutics is seeking a Scientist or Research Associate in its Process Development group to support its ongoing efforts to develop immunotherapies for the benefit of patients with cancer. Depending on previous experience and qualifications, this individual will be expected to either lead or support the process development and process characterization of scale-up/scale-down cell manufacturing processes, including optimizing process parameters, cell concentrations and therapeutic product fill and finish technologies to advance our therapeutic programs. The successful candidate must be a team player with strong expertise in process development and must have the ability to communicate and collaborate within an interdisciplinary environment.

Responsibilities:

  • Perform aseptic cell growth and manipulation procedures, such as cell isolation or enrichment, culture, cryopreservation and cell product thaw/wash.
  • Perform error-free calculations to determine cell viability, dilutions, and cell concentrations.
  • Possess strong experience with immunological techniques, including multi-parameter flow cytometry and ELISpot.
  • Perform procedures and maintain accurate documentation in compliance with FDA’s Good Laboratory Practices as well as familiarity with Good Manufacturing Practices.
  • Prepare and participate in technology transfers to CMOs and contract testing laboratories.
  • Participate in the preparation of CMC sections for regulatory submissions (IND, Annual Reports, and BLA), invention disclosures, progress reports, and publications.
  • Communicate research and development findings with internal and external partners

Minimal Experience and Skills:

  • BS, MS in Biology or a related science with 5+ years of relevant industry/academia experience.
  • Ph.D. in Biology or a related science with 2+ years of relevant industry/academia experience.
  • Expertise in process development and process characterization of scale-up/scale-down cell manufacturing processes, including optimizing process parameters, cell concentrations and therapeutic product fill and finish required.
  • Experience with T cell-based therapies preferred.
  • Attention to detail, ability to problem-solve, manage workflow, meet deadlines, communicate and work in a fast-paced team environment required.

To apply, please submit your CV to HR@markertherapeutics.com.

Sterility Assurance Director

The Sterility Assurance Director will join a newly formed Quality team and report directly to VP of Quality. This person is responsible for governance of sterility assurance and contamination control program including set-up of QC microbiology laboratory, GMP facility qualification, aseptic process simulation, disinfection procedures / practices, disinfectants qualification, cleaning validation, environmental monitoring program and microbiological testing of cell therapy product. The Sterility Assurance Director is also responsible for the development, implementation and compliance of activities in the microbiology laboratory area to meet production goals, quality, and cost objectives. The Sterility Assurance Director will be expected to have extensive knowledge and experience in developing and implementing contamination control methodologies in pharmaceutical or biological industries.

This position plays a lead role within Marker’s GMP process, works closely across Marker Quality, Manufacturing and Regulatory teams to ensure that ongoing clinical trials meet global regulatory and business requirements. This position represents the company both internally and externally. Lastly, the position helps to drive a ‘culture of quality’ at Marker.
Position Responsibilities

  • Understands and effectively communicates to team members about the contemporary Sterility Assurance practice
  • Ensures that team objectives align with key Company strategic goals and programs
  • Successfully manages and meets agreed upon milestones for key Company projects
  • Develops and implements appropriate systems to achieve a level recognized as aseptic excellence
  • Serves as the primary subject matter expert in Microbiology, aseptic processing and Contamination Control risk assessment and mitigation strategies
  • Interacts with operations support teams who are responsible for disinfection procedure/practices, aseptic manufacturing, and Facilities
  • Oversees the completion of projects through the development and approval of schedules, project plans, master plans, protocols and reports for systems to support laboratory and contamination control plan
  • Oversees the Aseptic Gowning and Training Program
  • Coordinates activities of QC personnel engaged in environmental samples collection, processing and data evaluation
  • Oversees shipment and testing of microbial samples contracted to CTOs
  • Assigns analysts to specific testing functions and executes tests when needed
  • Supports, mentors, trains and educates sterility assurance owners in planning and executing the contamination control processes, best practices, and record / documentation content
  • Provides leadership and direction for laboratory test-method validation, media qualification, and disinfectants qualification; support for validation protocol development and execution including bioburden recovery efficiency studies, mycoplasma, endotoxin and sterility
  • Supports day-to-day functions and initiatives regarding contamination control, including staffing, sample collection, processing and quality control of test methods
  • Leads investigations to environmental excursions and assists with CAPAs
  • Ensures the proper investigation into the root cause of product and/or process failures and assists in determining appropriate product disposition and/or process improvements
  • Develops, writes and revise SOP’s
  • Recommends implementation of new laboratory equipment
  • Maintains thorough documentation of environmental monitoring studies; performs data trending
  • Maintaining current working knowledge of regulations that may have impact on role.
  • Other duties as assigned.

Skills, Education and Experience Required

  • Master’s degree in Microbiology, Biological Sciences or a related field
  • Minimum of 10 years of experience in an aseptic manufacturing environment (cell and gene therapy) in an influential role, preferably with experience in a Quality organization (e.g. Quality Manager, Director or Senior Technical Consultant)
  • Proven ability to lead, coach, and motivate employees, clearly communicate job requirements and effectively manage performance of assigned staff with a minimum of three years in a management position
  • Strong knowledge of pharmaceutical microbiology and contamination control
  • Sound knowledge of aseptic processing and supporting technologies
  • A minimum of 5 years of cleanroom facility and microbial rapid test methods validation experience
  • Previous experience working with non-conformances, and corrective action and preventive action processes
  • Experience writing and reviewing technical documentation
  • Ability to work both independently without supervision and be a part of a team, demonstrating excellent communication skills
  • Strong problem solving and analytical skills with demonstrated ability to manage a number of projects simultaneously is a must
  • Must have excellent oral, written and interpersonal skills, are required
  • Ability to effectively plan and organize work activities and prioritize task completion to adhere to schedules and deadlines
  • Extensive knowledge of cGMP, ICH and FDA compliance

To apply, please submit your CV to HR@markertherapeutics.com.