Careers

Interested in bringing the promise of cell therapy to life for patients with cancer?

We’re seeking exceptional candidates who are passionate about changing the course of history for patients with cancer.

If that’s you, consider applying for our current openings. If there are currently no roles open, please feel free to email your interest to:
careers@chimerictherapeutics.com

Director/Senior Director of Process Development and Manufacturing Technology

Role Overview

The Director of Process Development and Manufacturing Technology reports to the VP, Technical Operations. This role will work closely with internal and external collaborators, lead the process development and technology transfer for current and future cell therapy assets from academic institutional partners to CDMO to ensure alignment with corporate and clinical timelines. The qualified candidate will have the expertise and deep knowledge of the scientific and technical approaches to genetically modify, characterize and scale up the production of such cell products. This role will lead process development, characterization, and validation studies to bring novel cell products to the clinic and commercialization. In addition, this role will establish the function of Process Development and Manufacturing Technology, supervise and coordinate internal and external engineers/scientists in the design and execution of activities related to immune cell process development, and manufacturing sciences and operations.

Key Responsibilities
  • Lead the technology transfer for current and future assets from academic institutional partners to CDMO manufacturing.
  • Oversee CDMO development operations and ensure effective development, tech transfer, and validation of processes.
  • Act as the primary CMC contact with internal and external functions for cell therapy assets.
  • Direct process development and optimization of manufacturing platform across multiple products.
  • Responsible for process characterization and validation strategy and execution.
  • Provide SME oversight through batch record review, deviation assessment, batch disposition.
  • Write study development reports, process characterization reports, transfer documents, and regulatory documents.
  • Assist in the generation of project and cost proposals, timelines, and work plans by applying scientific knowledge and project management experience.
  • Support regulatory submissions and support interactions with health authorities.
  • Continuously monitor, analyze, and optimize the end-to-end process and anticipate and resolve issues that may arise during production.
  • Support production-related investigations, ensuring compliance with internal standards and regulatory requirements.
  • Lead the development of the CMC databases and data mining initiatives.
  • Maintain current awareness of GMP and other regulations, guidance documents, industry standards, and trends that are applicable to current and future cell therapy operations and products.
  • Prepare, evaluate, and present data to internal and external stakeholders.
  • Hire and manage a team of scientists/engineers for process development & characterization, technology innovation.
Professional Experience/Qualifications
  • A MS/Ph.D. in Chemical Engineering, Biochemical Engineering, Biochemistry, or other relevant disciplines with experience in cell therapy/biologics process development.
  • Experience developing immunotherapy cell products and successful track record of taking cell therapy-based products to IND and early phase clinical trials. 
  • Experiences with cell therapy products, gene editing technologies, and viral vector process and production are preferred. 
  • Knowledge and experience with process development, characterization, and transfer are essential. Expertise in DOE and statistical analysis of data is a plus.
  • Experience working with and managing third-party contractors and vendors.
  • Experience with GMP manufacturing.
  • Demonstrated experience with scientific and technical writing in regulatory submissions.
  • Ability to foster a strong team-first environment with the ability to lead multiple projects. Self-motivation, excellent time management, organizational, written, and oral communication skills.
  • Demonstrated collaboration skills working cross-functionally, maintain strong stakeholder relationships, influencing direction, voicing opinion, and communicating effectively.
  • Ability to work with others to troubleshoot complex technical and scientific problems.
  • Demonstrated excellence in developing, mentoring, and managing staff.

Director/Senior Director CMC Project Leader

Chimeric Therapeutics is a clinical stage cell therapy company focused on bringing the promise cell therapy to life for more patients with cancer. We believe that cellular immunotherapies have the promise to cure cancer, not just delay disease progression.  To bring that promise to life for more patients, Chimeric’s world class team of cell therapy pioneers and experts is focused on the discovery, development, and commercialization of the most innovative and promising cell therapies.

We are currently seeking CMC Project Leader to join our growing dynamic team. This individual will be responsible for being the strategic and tactical leader that will establish and manage the CMC technology transfer and development plan for Chimeric assets.

This role reports to the VP, Technical Operations.

Key Responsibilities
  • Drive the CMC development of our assets by working cross functionally to navigate the team through the complexities of tech transfer and ensure all elements of development are advancing to meet project timelines and milestones.
  • Ensure overall program development in alignment with strategy and timelines by working in close collaboration with clinical project manager.
  • Assess needs and provide options for CMC development to align with the project objectives, with recommendations based on sound judgement on both short- and long-term implications (risks, costs, resources, and time).
  • Develop and execute project plans utilizing core PML methodologies, tools, and frameworks to operationalize the strategy and accomplish the project aligned objectives to time, budget and resource forecasts.
  • Optimize plans through constructive challenge and continuous dialog with the different functions to ensure all activities are aligned with team goals and objectives.
  • Drive insight generation, interpretation, and implementation to facilitate decision making and strategy refinement.
  • Operationalize, track, and manage project milestones, costs, resources, risks, quality, and timelines and detecting problems early throughout the lifespan of the project and implementing solutions.
Professional Experience/Qualifications
  • A MS/Ph.D. in Chemical Engineering, Biochemical Engineering, Biochemistry, or other relevant disciplines with experience in cell therapy/biologics process development.
  • In-depth technical understanding of drug development of gene or cell therapy products (preferred) or biologics, including Process/Analytical Development, and GMP Manufacturing, and CMC Regulatory.
  • Strong knowledge of current Good Manufacturing Practices (GMP), drug and biologics development regulations and guidelines including ICH, EMA, and FDA guidelines.
  • Experience with GMP manufacturing.
  • Deep experience in project management.
  • Excellent communication skills with the ability to influence across all functions and levels within the organization and with external stakeholders.
  • Excellent written and communication skills, strong technical knowledge, including CMC regulatory writing and ability to influence across multiple functions.
  • Demonstrated experience with scientific and technical writing in regulatory submissions.
  • Ability to foster a strong team-first environment with the ability to lead multiple projects. Self-motivation, excellent time management, organizational, written, and oral communication skills.
  • Demonstrated collaboration skills working cross-functionally, maintain strong stakeholder relationships, influencing direction, voicing opinion, and communicating effectively.
  • Ability to work with others to troubleshoot complex technical and scientific problems.

Vice President of Clinical Regulatory Affairs

Role Overview

Chimeric Therapeutics is a clinical stage cell therapy company focused on bringing the promise of cell therapy to life for more patients with cancer. We believe that cellular immunotherapies may be able to cure cancer, and not just delay its progression.  To bring that promise to life for more patients, Chimeric’s world class team of cell therapy experts is focused on the discovery, development, and commercialization of innovative cell therapies.

The Vice President of Clinical Regulatory Affairs reports to the Chief Medical Officer. The successful candidate will work closely with internal and external collaborators to shape and deliver on the regulatory strategy of Chimeric’s Clinical Programs while maintaining alignment with corporate and clinical timelines. These activities include leading interactions with health authorities, leading and contributing to submission management activities, and developing Chimeric’s regulatory function processes including appropriate build-out of the regulatory team.  The qualified candidate will have the regulatory expertise and knowledge necessary to advance Chimeric’s candidates from first-in-human clinical trials through global marketing authorizations and beyond.

Key Responsibilities – The successful candidate:
  • Is a key member of Chimeric Project Teams and regulatory subject matter expert engaging with cross-functional team members to deliver on the promise of Chimeric’s product candidates.
  • Works closely with the executive leadership team to develop and execute on regulatory plans that result in the successful registration and post-approval commercialization of Chimeric’s product candidates
  • Provides strategic and tactical direction to drive cross-discipline consistency in regulatory approach and planning.
  • Serves as primary regulatory agency contact (at the FDA and at other agencies) to achieve Chimeric’s regulatory objectives, by fostering strong relationships and acting as a credible, reputable, and effective advocate for our programs.
  • Serves as key point of contact for managing and directing regulatory inspections.
  • Develops and executes on strategies for ex-US marketing authorizations of Chimeric’s product candidates.
  • Develops and implements robust regulatory structures, processes, and procedures.
  • Provides guidance and critical evaluation of potential business development opportunities.
  • Provides regulatory review and approval of product labeling, promotional claims, and advertising to ensure compliance with corporate policy, and US and international laws and regulations.
  • Directs long and short-term departmental planning including structure, headcount, budgeting, training, and systems requirements.
  • Manages internal regulatory procedures to ensure compliance.
  • Manages external regulatory vendor and platform service team members and providers.
  • Hires, onboards, and manages regulatory professionals.
Professional Experience/Qualifications

Candidates for this position should hold the following qualifications, have the following experience, and be able to demonstrate the following abilities to be considered as a suitable applicant. Please note that except where specified as “preferred,” all points listed below are considered minimum requirements.

Performs responsibilities competently and with limited guidance.

  • Makes decisions based on impeccable ethics.
  • Demonstrates outstanding attention to detail.
  • Prioritizes multiple tasks and goals and delivers high-quality results on time, on-target and within budget guidance.
  • Communicates effectively:
    • Influences without authority and has proven experience building and cultivating relationships with key partners and stakeholders, both internally and externally.
    • Presents information and key considerations clearly and succinctly.
    • Interacts confidently and competently with internal/external stakeholders
    • Negotiates and works effectively with others internally and externally to drive toward desired results.
  • Approaches cross-functional problem-solving thoughtfully to effectively identify and address important factors affecting regulatory strategies.
  • Able to travel within North America (<25%.)
Education and Experience
  • Advanced clinical/science degree required (MD, PharmD, PhD, MSN, MPH, etc.).
  • Minimum 10 years in pharmaceutical / biopharmaceutical industry (ideally both small and large companies)
  • Extensive regulatory management experience and in developing innovative regulatory solutions.
  • Track record of success in gaining approval of original NDAs, MAAs and / or BLAs
  • Experience with cell and gene therapy products/ complex biological products
  • Experience with oncology products
  • Relevant knowledge in CMC, clinical and nonclinical science
  • Knowledge expert in global regulatory submission standards and publishing best practices.
  • Knowledge expert in global cell therapy product development guidelines