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, tion, respect and commitment to our community with accountability.
- 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.
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
Minimal Experience and Skills:
- BS, MS in Biology or a related science with 3+ 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.
Reports to: Sr. Director of CMC
Resumes can be sent to: HR@markertherapeutics.com