Why Work Here?

About CTMC 

CTMC is a pioneering biotech joint venture, formed by National Resilience and MD Anderson Cancer Center, and located in the renowned Texas Medical Center. Our mission is to accelerate cell therapies from bench to bedside. We offer a wide range of cell therapy modalities, including CAR-T, TIL, ETC, and TCR-T. Our expert team collaborates closely with MD Anderson’s research and clinical faculty, bringing impactful cell therapies to cancer patients. 

In our first year alone, we have filed four INDs, each ahead of schedule, demonstrating our commitment to delivering innovative treatments to patients with speed and precision. Our alliance with National Resilience, an ambitious biomanufacturing organization that has raised $2 billion in two years, enables us to remain at the forefront of biomanufacturing practices, leveraging advanced technology and processes to deliver exceptional results. 

Our state-of-the-art, 60,000 sq. ft. facility in the Texas Medical Center is staffed by an integrated team of 75 industry veterans and scientists who are passionate about bringing life-saving cures to patients. Our unique joint venture structure, with two highly established partners, provides us with the financial stability and long-term horizon to achieve our mission. 

At CTMC, we value our employees and offer a variety of development opportunities within our novel corporate structure. We foster a team-first culture and a balanced work-life environment to ensure our staff is energized and engaged in our mission. If you share our passion for advancing the frontiers of medical science with innovative therapeutics and want to join a highly dedicated team committed to delivering novel cures to patients, we invite you to submit your application. We look forward to hearing from you and exploring how your skills and expertise can help us achieve our mission. 

Responsibilities 

CTMC is looking for a highly motivated Project Leader with exceptional scientific and communication skills to support our Houston, TX development and manufacturing site. This position will be responsible for managing execution of cell therapy projects including cross-functional planning and execution, aligning scientific and therapeutic strategy, early phase development, CMC, and regulatory filing to enable accelerated FDA approval and patient access to life saving therapies. Prior experience leading and managing complex and cross-functional projects is required, and a strong understanding of CMC and drug development is preferred, as well as a demonstrated mastery of scientific understanding of cell therapies.  This role will report to the Head of Project and Alliance Leadership. 

Directly manage multiple development projects, leading cross-functional teams through strategy, planning and execution of projects, and driving these projects to IND filing and first in human clinical trials.  

• Project leadership will encompass cell therapy programs that are developed in collaboration with MDACC faculty and with biotechnology companies.  
• Drive novel cell therapy projects through IND studies to first-in-human clinical trials; leading at least 2 programs to the clinic over the first 12 months.
• Coordinate development activities to assure a high-quality process and assays are ready for Manufacturing and QC on time. 
• Oversee the transition from Development into Manufacturing and the execution of supportive engineering runs. 
• Coordinate functional groups with Regulatory to generate pre-IND and IND submissions and those regulatory strategies are clearly communicated. 
• Manage the alliance with partners developing innovative, curative cell therapies. Use scientific knowledge and thinking to propel projects through execution. 

Prepare, track and report project scope of work, project plans and budgets.  

Monitor project progress and ensure execution and accountability within the team. 

Monitor and track grant and award progress setting targets for milestones, collaborating with other departments as needed. 

Participates in scientific writings including manuscripts, commentaries, short communications, and grant proposals. 

Proactively identify project issues, potential risks, and delays, and provide strategies for risk mitigation.  

Clearly and effectively communicate project progress and provide visibility to the project team, functional heads, senior management, and external partners.  

Contribute to the organizational and project governance structure: 

• Provide visibility across projects and departments. 
• Facilitate and support project transitions between departments to move projects from development space into the GMP environment and through IND submission. 

Other duties as required.

Qualifications/Skills 

• Bachelor’s degree or Master’s in engineering, science, or related field required, PhD preferred. 
• 15+ yr.’s. of relevant work experience, including 6+ yr.’s. of project leadership/ management in cell therapy or closely related field or equivalent combination of education and experience. 
• 5+ yr.’s experience with Cell Therapy manufacturing preferred. 
• Previous product development grant and award program experience preferred. 
• Demonstrate familiarity with Biologics development to IND, required. 
• High-level of communication skills required, both written and verbal. 
• Demonstrate organization, focus and diplomacy skills. 
• Demonstrate high level of emotional intelligence and the ability to create a collaborative trusting team. 
• Ability to work well under pressure, complete tasks to defined schedules, and effectively plan, organize, and coordinate multiple priorities. 
• Experience auditing, conducting management reviews, interpreting state laws, and policies and procedures pertaining to grant awards. 
• Ability to compose clear and concise written reports, to gather and analyze accurate and relevant audit and compliance information. 
• Possess mindset focus on strategic thinking, data-driven decision making and effective communication. 
• Proficient in Microsoft Outlook, Teams, Project, Excel, SharePoint, and PowerPoint. 
• Previous experience with matrix project management and/ or agile project management is beneficial. 
• Ability to work onsite as needed (remote candidates will be considered with some travel required 25% of the time), relocation preferred. 

Working Conditions, Equipment, Physical Demands  

The incumbent in this position works in an office environment. The incumbent in this position will use the following equipment and shall have the following physical demands:  

Equipment- Computer, printer, fax, and telephone. 

Physical Demands- Prolonged periods of sitting at a desk and working on a computer and must be able to lift up to 15 pounds at times. In addition, ability to sterile-gown and perform activities in the manufacturing suite as well as raw material area when applicable. 

The physical demands and work environment that have been described are representative of those an employee encounters while performing the essential functions of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions in accordance with the Americans with Disabilities Act.  

The above job description is an overview of the functions and requirements for this position.  This document is not intended to be an exhaustive list encompassing every duty and requirement of this position; your supervisor may assign other duties as considered necessary.  

About CTMC 

     CTMC is a pioneering biotech joint venture, formed by National Resilience and MD Anderson Cancer Center, and located in the renowned Texas Medical Center. Our mission is to accelerate cell therapies from bench to bedside. We offer a wide range of cell therapy modalities, including CAR-T, TIL, ETC, and TCR-T. Our expert team collaborates closely with MD Anderson’s research and clinical faculty, bringing impactful cell therapies to cancer patients.

 In our first year alone, we have filed four INDs, each ahead of schedule, demonstrating our commitment to delivering innovative treatments to patients with speed and precision. Our alliance with National Resilience, an ambitious biomanufacturing organization that has raised $2 billion in two years, enables us to remain at the forefront of biomanufacturing practices, leveraging advanced technology and processes to deliver exceptional results. 

Our state-of-the-art, 60,000 sq. ft. facility in the Texas Medical Center is staffed by an integrated team of 75 industry veterans and scientists who are passionate about bringing life-saving cures to patients. Our unique joint venture structure, with two highly established partners, provides us with the financial stability and long-term horizon to achieve our mission. 

At CTMC, we value our employees and offer a variety of development opportunities within our novel corporate structure. We foster a team-first culture and a balanced work-life environment to ensure our staff is energized and engaged in our mission. If you share our passion for advancing the frontiers of medical science with innovative therapeutics and want to join a highly dedicated team committed to delivering novel cures to patients, we invite you to submit your application. We look forward to hearing from you and exploring how your skills and expertise can help us achieve our mission.

Summary: 

Reporting to the Head of Regulatory Affairs, the Manager, Regulatory Affairs CMC will provide support for the regulatory affairs department with a primary focus on driving cell and gene therapy projects that are developed in collaboration with MD Anderson Cancer Center and with biotechnology companies to IND filing and first-in-human clinical studies. The Manager, Regulatory Affairs CMC is responsible for supporting multiple projects per year as they progress from preclinical POC to clinical POC .

CTMC has a unique, flexible and value-added partnership model with biotech companies and MD Anderson Cancer Center. The role will be a central player in this nexus and ensure clear communication of roles and responsibilities across the partners to enable efficient execution of IND-enabling activities, IND submissions and lifecycle management. 

 Responsibilities

• Support assigned projects by providing minimal regulatory filing requirements, submission strategy, and regulatory risk assessments in support of CMC development of early-stage cell and gene therapy products.
• Work closely with various functions to coordinate preparation of regulatory filings, identification of issues and factors that may impact a regulatory strategy or activity.
• Support development of high quality, compliant and timely regulatory submissions that require extensive interaction with departments outside of Regulatory Affairs and outside of CTMC.
• Ensure submission readiness at the document-level, including document formatting and PDF generation, bookmarking, and hyperlinking. 
• Compile, publish and submit in eCTD via the Electronic Submissions Gateway using Veeva Vault RIM.
• Monitor and, as necessary, provide data to be entered into tracking systems for department deliverables and ensure information is current.
• Contribute to process improvements (e.g., policies, SOPs, work instructions) which have a significant impact on business.
• Evaluate change proposals for regulatory impact and support CMC information amendments.
• Other duties as required.

Qualifications:

• Master’s degree in a relevant science discipline, or PhD preferred, minimum Bachelor’s degree required.
• 7 yr.’s relevant experience including 5+ yr.’s working within the biotech/pharmaceutical industry and 3+ yr.’s of biotech/pharmaceutical Regulatory Affairs CMC experience or equivalent combination of education and experience.
• Prior experience with cell and/or gene therapy products strongly preferred.
• Strong attention to detail and an ability to prioritize effectively.
• Strong analytical and problem-solving skills.
• Excellent written and verbal communication skills.
• Proficient in various computer applications such as Office suite, Veeva, Smartsheet, etc.

Working Conditions, Equipment, Physical Demands 

The incumbent in this position works in an office environment. The incumbent in this position will use the following equipment and shall have the following physical demands:

Equipment- Computer, printer, fax, and telephone

Physical Demands- 

• Prolonged periods of sitting at a desk and working on a computer

The physical demands and work environment that have been described are representative of those an employee encounters while performing the essential functions of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions in accordance with the Americans with Disabilities Act. 

The above job description is an overview of the functions and requirements for this position.   This document is not intended to be an exhaustive list encompassing every duty and requirement of this position; your supervisor may assign other duties as considered necessary. 

About CTMC

CTMC is a pioneering biotech joint venture, formed by National Resilience and MD Anderson Cancer Center, and located in the renowned Texas Medical Center. Our mission is to accelerate cell therapies from bench to bedside. We offer a wide range of cell therapy modalities, including CAR-T, TIL, ETC, and TCR-T. Our expert team collaborates closely with MD Anderson’s research and clinical faculty, bringing impactful cell therapies to cancer patients.

In our first year alone, we have filed four INDs, each ahead of schedule, demonstrating our commitment to delivering innovative treatments to patients with speed and precision. Our alliance with National Resilience, an ambitious biomanufacturing organization that has raised $2 billion in two years, enables us to remain at the forefront of biomanufacturing practices, leveraging advanced technology and processes to deliver exceptional results.

Our state-of-the-art, 60,000 sq. ft. facility in the Texas Medical Center is staffed by an integrated team of 75 industry veterans and scientists who are passionate about bringing life-saving cures to patients. Our unique joint venture structure, with two highly established partners, provides us with the financial stability and long-term horizon to achieve our mission.

At CTMC, we value our employees and offer a variety of development opportunities within our novel corporate structure. We foster a team-first culture and a balanced work-life environment to ensure our staff is energized and engaged in our mission. If you share our passion for advancing the frontiers of medical science with innovative therapeutics and want to join a highly dedicated team committed to delivering novel cures to patients, we invite you to submit your application. We look forward to hearing from you and exploring how your skills and expertise can help us achieve our mission.

Responsibilities (The responsibilities listed are specified as but not limited to):

• Perform line-clearance/ change-over activities.
• Support disposition/ Hold/ Rejection of raw materials, starting material, in-house prepared materials, intermediates, and drug product.
• Generate and reconcile in-process and Drug Product labels.
• Review and approve executed documents related to manufacturing operations, QC, and other departments.
• Initiate, author, review and approve deviations, CAPAs and Change Controls associated with Quality Operations practices.
• Create, review, and approve procedures and practices within Quality Operations to implement company quality standards.
• Partner with other departments to implement, optimize, review, and approve batch records, practices, and procedures.
• Train and motivate employees to Quality Operations procedures and practices to ensure that quality standards are met.
• Participate in recruitment efforts.
• Other duties as required.

Qualifications/Skills

• Bachelor’s degree in a scientific field required.
• 5+ yrs in Quality Assurance within the field or an equivalent combination of education and experience.
• Understanding of Cell and Gene Therapies.
• Understanding of cGMPs, GLPs and GXPs.
• Knowledge of local and global regulations.
• Verbal and written communication skills.
• Interpersonal and customer service skills.
• Organizational skills and attention to detail.
• Time management skills with a proven ability to meet deadlines.
• Analytical and problem-solving skills.
• Supervisory skills.
• Able to work late nights, weekends, and holidays with very short advance notice.
• Proficient with Microsoft Office Suite or related software.

Working Conditions, Equipment, Physical Demands

The incumbent in this position works in an office environment. The incumbent in this position will use the following equipment and shall have the following physical demands:

Equipment- Computer, printer, fax, and telephone.

Physical Demands- Prolonged periods of sitting at a desk and working on a computer and must be able to lift up to 15 pounds at times. In addition, ability to sterile-gown and perform activities in the manufacturing suite as well as raw material area when applicable.

The physical demands and work environment that have been described are representative of those an employee encounters while performing the essential functions of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions in accordance with the Americans with Disabilities Act.

The above job description is an overview of the functions and requirements for this position.  This document is not intended to be an exhaustive list encompassing every duty and requirement of this position; your supervisor may assign other duties as considered necessary.

About CTMC

CTMC is a pioneering biotech joint venture, formed by National Resilience and MD Anderson Cancer Center, and located in the renowned Texas Medical Center. Our mission is to accelerate cell therapies from bench to bedside. We offer a wide range of cell therapy modalities, including CAR-T, TIL, ETC, and TCR-T. Our expert team collaborates closely with MD Anderson’s research and clinical faculty, bringing impactful cell therapies to cancer patients.  

In our first year alone, we have filed four INDs, each ahead of schedule, demonstrating our commitment to delivering innovative treatments to patients with speed and precision. Our alliance with National Resilience, an ambitious biomanufacturing organization that has raised $2 billion in two years, enables us to remain at the forefront of biomanufacturing practices, leveraging advanced technology and processes to deliver exceptional results.  

Our state-of-the-art, 60,000 sq. ft. facility in the Texas Medical Center is staffed by an integrated team of over 80 industry veterans and scientists who are passionate about bringing life-saving cures to patients. Our unique joint venture structure, with two highly established partners, provides us with the financial stability and long-term horizon to achieve our mission.

At CTMC, we value our employees and offer a variety of development opportunities within our organization. We foster a team-first culture and a balanced work-life environment to ensure our staff is energized and engaged in our mission. If you share our passion for advancing the frontiers of medical science with innovative therapeutics and want to join a highly dedicated team committed to delivering novel cures to patients, we invite you to submit your application. We look forward to hearing from you and exploring how your skills and expertise can help us achieve our mission. 

Responsibilities

• Support all day-to-day functions and perform routine analysis of in-process, finished product and stability samples as outlined in laboratory procedures.
• Demonstrate aseptic processing capability of samples for relevant tests.
• Participate in assay transfer and qualification studies.
• Perform microbiological media qualification, sterility, growth promotion and pH testing.
• Perform Environmental Monitoring (air, surface, and personnel) for the GMP controlled areas.
• Generate trend analysis for environmental monitoring.
• Demonstrate technical proficiency in analytical procedures including but not limited to thaw and culture of cryopreserved cells/cell lines, DNA isolation, cell counting, flow cytometry, etc.
• Author and revise Standard Operating Protocols (SOPs) for test methods, OMC protocols for equipment, and other documents requested by the supervisor.
• Assist supervisor in performing laboratory investigation procedures and interpreting OOS and OOT test results.
• Plan and coordinate with other departments to ensure continuous and timely testing of clinical and stability samples.
• Oversee shipment and testing of analytical samples at contract testing organizations.
• Take ownership responsibility of one of the Quality Control Laboratory functions to maintain, track and update QC management.
• Maintain and care of the laboratory equipment and perform good housekeeping activities.
• Complete all training requirements in a timely manner.
• Work with other departments providing applicable assistance and/or serving as a subject matter expert.
• Other duties as assigned.

Qualifications/Skills

• Bachelor’s degree in Biological Sciences, Biotechnology or a related field required.
• 1+ yr.’s experience in an aseptic manufacturing environment (cell and gene therapy), preferably with experience in a Quality organization preferred, 0+ yr.’s required or equivalent combination of education and experience.
• Knowledge of cGMP and FDA regulations.
• Experience working with non-conformances and/or laboratory investigations.
• Experience in cell therapy analytical methods (biological and microbiological) is preferred.
• Ability to work both independently without supervision as well as be part of a team; excellent communication and interpersonal skills, is required.
• Ability to effectively plan and organize activities and prioritize task completion to meet assigned schedule and deadlines.
• Capable of working in a fast-paced environment and communicating effectively with a diverse work group.

Working Conditions, Equipment, Physical Demands

The incumbent in this position works in an office environment. The incumbent in this position will use the following equipment and shall have the following physical demands:

Equipment- Computer, printer, fax, telephone, and laboratory testing equipment

Physical Demands-

• Occasional standing and walking required
• Frequent sitting, reaching, and computer/keyboard usage
• Occasional lifting, pushing, and pulling up to 10 lbs. required.

The physical demands and work environment that have been described are representative of those an employee encounters while performing the essential functions of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions in accordance with the Americans with Disabilities Act.

The above job description is an overview of the functions and requirements for this position.  This document is not intended to be an exhaustive list encompassing every duty and requirement of this position; your supervisor may assign other duties as considered necessary.

About CTMC 

CTMC is a pioneering biotech joint venture, formed by National Resilience and MD Anderson Cancer Center, and located in the renowned Texas Medical Center. Our mission is to accelerate cell therapies from bench to bedside. We offer a wide range of cell therapy modalities, including CAR-T, TIL, ETC, and TCR-T. Our expert team collaborates closely with MD Anderson’s research and clinical faculty, bringing impactful cell therapies to cancer patients.  

 In our first year alone, we have filed four INDs, each ahead of schedule, demonstrating our commitment to delivering innovative treatments to patients with speed and precision. Our alliance with National Resilience, an ambitious biomanufacturing organization that has raised $2 billion in two years, enables us to remain at the forefront of biomanufacturing practices, leveraging advanced technology and processes to deliver exceptional results.  

 Our state-of-the-art, 60,000 sq. ft. facility in the Texas Medical Center is staffed by an integrated team of over 80 industry veterans and scientists who are passionate about bringing life-saving cures to patients. Our unique joint venture structure, with two highly established partners, provides us with the financial stability and long-term horizon to achieve our mission.

  At CTMC, we value our employees and offer a variety of development opportunities within our organization. We foster a team-first culture and a balanced work-life environment to ensure our staff is energized and engaged in our mission. If you share our passion for advancing the frontiers of medical science with innovative therapeutics and want to join a highly dedicated team committed to delivering novel cures to patients, we invite you to submit your application. We look forward to hearing from you and exploring how your skills and expertise can help us achieve our mission. 

Responsibilities

• Performs analytical testing on cell and viral therapy products, to verify product quality, purity, and safety. 
• Accurately perform, analyze, and demonstrate proficiency on the following tests:

1. Molecular PCR assays; Vector Copy Number (VCN), Replication Competent Retrovirus (RCR), and Mycoplasma testing using qPCR and ddPCR technology.
2. Automated and manual cell counts and viability.
3. Flow cytometry analysis

• Demonstrate aseptic processing of samples for relevant tests.
• Follows laboratory’s quality control policies and procedures. 
• Documents all quality control activities according to SOPs.  
• Performs and documents equipment maintenance and calibration activities according to SOPs.  
• Assists in writing new SOPs, and revising SOPs for test methods, equipment maintenance, and general laboratory practices. 
• Execute daily lab responsibilities and tasks to meet assigned schedule and deadlines. 
• Perform stability testing as scheduled and specified in the stability studies or protocol for cell therapy and viral supernatant products. 
• Assist in performing laboratory investigations and OOS and OOT analysis. 
• Assist in the execution of validation/qualification programs per ICH guidelines, cGMP and cGTP and other applicable standards. 
• Assist with equipment qualification, validation programs and/or performance qualification programs. 
• Reference material/standards characterization and trending. 
• Assist with technology transfer activities. 
• Assist area management to ensure that the lab is always in a state of readiness for a given area of relevant standards and regulations. 
• Ship and receive materials and samples to support QC testing and release. 
• Support inventory management for all QC lab activities. 
• Review and release raw materials to be used in GMP manufacturing. 
• Maintain laboratory upkeep and organization.
• Other duties as required. 

Qualifications/Skills

• Bachelor’s degree in science field required or equivalent combination of education and experience.
• 3 yr.’s analytical testing in a quality control laboratory including molecular assays, automated and manual cell counts and viability, flow cytometry analysis and ELISA.
• Demonstrate expertise for one or more assay categories.
• Experience with accurate laboratory calculations and conversions.
• Previous experience with writing SOPs preferred. 
• Demonstrated ability to collaborate effectively in a multi-disciplinary team. 
• Able to carry out planned laboratory activities with minimal supervision.
• Shows initiative to take on additional responsibility.
• Proficient with Microsoft Office (Excel, Outlook, etc.).
• Able to work flexible work hours to maintain critical testing during manufacturing runs.
• Capable of working in a fast-paced environment and communicating effectively with a diverse work group.

Working Conditions, Equipment, Physical Demands 

The incumbent in this position works in an office environment. The incumbent in this position will use the following equipment and shall have the following physical demands:

Equipment-

• Computer
• Printer
• Scanner
• Telephone
• Lab Equipment

Physical Demands-  

• Frequent sitting, standing, walking.
• Carrying packages and moving bins and boxes, lifting up to 10 lbs.

The physical demands and work environment that have been described are representative of those an employee encounters while performing the essential functions of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions in accordance with the Americans with Disabilities Act. 

The above job description is an overview of the functions and requirements for this position.  This document is not intended to be an exhaustive list encompassing every duty and requirement of this position; your supervisor may assign other duties as considered necessary. 

About CTMC

   CTMC is a pioneering biotech joint venture, formed by National Resilience and MD Anderson Cancer Center, and located in the renowned Texas Medical Center. Our mission is to accelerate cell therapies from bench to bedside. We offer a wide range of cell therapy modalities, including CAR-T, TIL, ETC, and TCR-T. Our expert team collaborates closely with MD Anderson’s research and clinical faculty, bringing impactful cell therapies to cancer patients.

In our first year alone, we have filed four INDs, each ahead of schedule, demonstrating our commitment to delivering innovative treatments to patients with speed and precision. Our alliance with National Resilience, an ambitious biomanufacturing organization that has raised $2 billion in two years, enables us to remain at the forefront of biomanufacturing practices, leveraging advanced technology and processes to deliver exceptional results.

Our state-of-the-art, 60,000 sq. ft. facility in the Texas Medical Center is staffed by an integrated team of 75 industry veterans and scientists who are passionate about bringing life-saving cures to patients. Our unique joint venture structure, with two highly established partners, provides us with the financial stability and long-term horizon to achieve our mission.

At CTMC, we value our employees and offer a variety of development opportunities within our novel corporate structure. We foster a team-first culture and a balanced work-life environment to ensure our staff is energized and engaged in our mission. If you share our passion for advancing the frontiers of medical science with innovative therapeutics and want to join a highly dedicated team committed to delivering novel cures to patients, we invite you to submit your application. We look forward to hearing from you and exploring how your skills and expertise can help us achieve our mission.

Responsibilities

• Develop robust processes of formulation, fill and finish, and cryopreservation for chimeric antigen receptor T (CAR T) and Tumor-Infiltrating Lymphocytes (TIL) cell products.
• Design and execute studies on formulation, fill/finish, and cryopreservation of candidate cell therapy product.
• Evaluate new cryobiological technologies. 
• Implement process advancements for scaling-up and introduction into a GMP manufacturing environment.
• Lead technology transfer activities and training manufacturing staff on new processes and equipment,
• Monitor process performance during clinical manufacturing via data tracking, trending, and analysis.
• Design and conduct experiments in development laboratory to support process changes, generate process robustness data, and/or resolve manufacturing non-conformances.
• Draft technical documents including development reports, process descriptions, risk assessments, SOPs, MBRs, and regulatory filing sections.
• Act as internal expert and maintain state-of-the-art knowledge in the field of cellular cryopreservation and cryobiology.
• Other duties as assigned.

Qualifications/Skills

• Ph.D. in a related scientific/engineering field preferred, or Master’s degree with 5+ years’ experience in a related field, preferably in the biotech industry or equivalent combination of education and experience.
• Strong knowledge and hands-on experience with cell therapy process development and cryopreservation.
•  Highly desired experience:

Formulation science experience with cryoprotectant additives.

Demonstrated aseptic cell handling skills.

Experience working in or supporting a cGMP-regulated environment.

Hands-on experience with common cell therapy laboratory equipment and technology platforms

• Familiarity with the following is a plus:

solid background in cell therapy manufacturing processes

• Proficient with MS Office (Excel, Outlook, etc.) and statistical software (Prism, JMP).
• Strong scientific understanding of the fundamental principles of cryopreservation and cell therapy.
• Demonstrated ability to collaborate effectively in a multi-disciplinary team.
• Demonstrated strong communication skills, interpersonal skills, and a superior drive for results.
• Excellent written, oral, interpersonal and presentation skills and the ability to effectively interface with senior management and staff.
• Excellent judgment and creative problem-solving skills, including negotiation and conflict resolution skills.

Working Conditions, Equipment, Physical Demands 

The incumbent in this position works in a lab and office environment. The incumbent in this position will use the following equipment and shall have the following physical demands:

Equipment-

Computer, printer, fax, telephone, and laboratory testing equipment

Physical Demands- 

• Occasional standing and walking required.
• Frequent sitting, reaching, and computer/keyboard usage.
• Occasional lifting, pushing, and pulling up to 10 lbs. required.

The physical demands and work environment that have been described are representative of those an employee encounters while performing the essential functions of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions in accordance with the Americans with Disabilities Act. 

The above job description is an overview of the functions and requirements for this position.  This document is not intended to be an exhaustive list encompassing every duty and requirement of this position; your supervisor may assign other duties as considered necessary.