Cytoimmune Therapeutics is hiring new team members who believe in the potential of engineered natural killer (NK)cells as off-the-shelf allogeneic cellular therapy products for the potential treatment of several diseases across multiple therapeutic areas. We are a fast growing, patient-focused team located in Toa Baja, Puerto Rico .
As a Scientist, Analytical Operations, you will help build the Analytical Operations team at Cytoimmune Therapeutics as follows:
· Join an innovative, multi-disciplinary team developing and implementing characterization strategies, analytical methods, and data analysis to support the advancement of Cytoimmune Therapeutics pipeline.
· Support the qualification and validation of analytical methods for identity, purity, strength,and potency, product characterization, and quality attribute assessment of Cytoimmune Therapeutics cell therapy programs.
· Work cross-functionally with scientists and engineers from Process Development, Manufacturing, and Quality Control to determine the appropriate methodologies to assess drug substances, drug products, intermediates, and critical reagents.
What you’ll do:
· Develop, improve robustness, qualify, and validate phase appropriate analytical methods for clinical stage cell therapy programs (60%)
· Understand and actively manage project timelines and deliverables and plan/coordinate project work accordingly with supervisor and functional stakeholders in Process Development, Manufacturing, and Quality Control.
· Contribute significantly to project work which may include multiple projects within Analytical Operations.
· Execution of laboratory experiments to support development and validation of analytical methods for cell therapy programs.
· Influence project strategy and communicates complex data/decisions within department and cross functionally as necessary.
· Planning, designing, and conducting experiments and data analysis to support the development and validation of analytical methods for cell therapy programs.
· Analyze experimental data and ensure timely documentation and record keeping in Electronic Notebook.
· Responsible for documentation of experimental data, generation of high-quality written study protocols, technical reports, and oral presentations.
· Ensures a productive and development rich environment, provides training/ mentoring for junior staff and leverages expertise in laboratory technology.
· Author, review and/or approve technical documents (protocols, reports, test methods, etc.) or content for regulatory filings ensuring high technical standards and compliance with applicable regulatory guidelines to support analytical methods (30%)
· Collaborate with Process Development, Manufacturing, and Quality Control to accelerate programs to IND and BLA.
· Design and participate in the validation and transfer strategy of analytical methods to support cell therapy product release.
· Responsible for execution and documentation of validation data, generation of high-quality written study protocols, validation reports, and leading cross functional meetings.
· Transfer methods to quality control and support their implementation and execution.
· Evaluation / Implementation of new technologies (10%)
· Participate or lead technology working groups to evaluate and implement new technologies related to analytical methods for cell therapy products.
· Identify, builds, and maintains relationships with vendors, and quality check study design, and gain access to technologies to deliver pipeline goals.
· Stay updated on new, relevant technologies and published literature to drive innovation within the group.
What we’re looking for
· Education and Behavioral Competencies
· PhD degree in biology, chemistry, immunology, pharmaceutical sciences, engineering, or related scientific discipline with 3+ years relevant experience in biopharmaceutical industry.
· Master’s in biology, chemistry, immunology, pharmaceutical sciences, engineering, or related scientific discipline with 9+years relevant experience in biopharmaceutical industry.
· BS in biology, chemistry, immunology, pharmaceutical sciences, engineering, or related scientific discipline with 12+ years industry experience.
· Extensive experience in CMC pharmaceutical development for active pharmaceutical ingredients and drug products under cGMP’s.
· Sound knowledge of current Good Manufacturing Practices (cGMP).
· Previous experience contributing to regulatory filing.
· Teamwork – Ability to work well in highly cross functional team environment and across functions.
· Knowledge Sharing – Ability to capture knowledge within the organization; improves solutions, processes, and deliverables through use of information; improves information capital by contributing experience, theories, deliverables, and models for others to use.
Knowledge and Skills
· Effective project and resource management skills.
· Excellent oral and written communication skills to present data and strategy.
· Deep expertise in analytical methods for biologics characterization and release.
· Analytical and Problem-Solving Skills – Able to troubleshoot critical issues or problems and determine causes and possible solutions.
· Resource Management -Ability to manage one’s time within individual and organization-wide goals and timelines.
What will separate you from the crowd
· Broad expertise in wide range of analytical methods including but not limited to cell-based potency assays, flow cytometry, ELISA multiplex and molecular assays to evaluated biological properties and process impurities.
· Deep experience of GMP manufacturing process, assay design and validation, cell therapy or biologics drug development.
· Strong understanding of tech transfer, product release & characterization testing, and vendor / CRO management is preferred.
· Extensive experience in CMC pharmaceutical development.
· Excellent organizational and communication skills.
· Able to work independently and function within a collaborative/team-oriented environment
· Innovative, critical, and creative thinker, unafraid to propose aggressive solutions to complex problems.
What you should know
· Working safely in person on a predictable and regular basis is an essential job function for this position and CytoImmune Therapeutics requires that all individuals, subject to certain exceptions, be fully vaccinated against COVID-19.
Job Type: Full-time
Pay: From $85,000.00 per year
- Dental insurance
- Employee assistance program
- Health insurance
- Vision insurance
- 8 hour shift
- Monday to Friday
- On call
- Bonus pay
Work Location: One location