Manufacturing Supervisor (Cell Therapy)-Full Time

Salary:

About TCRCure Biopharma Corp.:
TCRCure is a clinical-stage biotechnology startup that brings novel TCR-T and CAR-T cell therapies to patients. We focus on treating solid tumors in global patient populations with few treatment options. Over the past 3 years, we have launched our first 3 generations of T cell therapies, and we need YOUR help to launch the next one.
Job Description:
Currently, TCRCure is seeking a highly motivated cell therapy professional to lead our Los Angeles MFG team. Come lead our close-knit team as we manufacture our next-generation cell therapy products. You will perform daily manufacturing processes as well as lead the manufacturing group through our next stage of GMP production. Teamwork is key, and you will smoothly interact with quality and process development teams. This position will be based in Los Angeles, CA with 2-3 direct reports. The candidate will report to the Head of US Operations.

Essential Duties & Responsibilities:
• Lead cleanroom operations for the manufacture of T-cell/viral vector products in a cGMP environment, using proper aseptic technique, good documentation practices, and sound scientific methods.
• Ensure performance of all process steps specific to the phase or stage of operation
• Develop training plans for GMP plant operators and execute personnel training
• Participate in tech transfer from Process Development to clinical GMP manufacturing
• Assist with startup activities of flexible cGMP facility by collaborating with Process Development, Quality and Research departments
• Perform manufacturing processes on the floor, following batch records and standard operating procedures (SOPs) to ensure safe and compliant operations
• Review and author SOPs, MBRs and other controlled documents for equipment and procedures used in routine biologics manufacture
• Review of completed manufacturing documentation per compliance standards and established timelines
• Find opportunities for improvement in manufacturing. Assist with deviations and change controls
• Lead team and manage process planning/scheduling and resourcing of personnel

Qualifications and Skills:
• Minimum of bachelor’s degree in biology, biochemistry or other relevant life science
• 3-5 years GMP experience in regulated pharmaceutical/biotechnology lab environment
• Excellent aseptic/sterile techniques
• Prior experience with cell or gene therapy manufacturing is preferred
• Knowledgeable of the current Code of the Federal Regulations (CFR's) and Current Good Manufacturing Practices (cGMP's)
• Sufficient understanding of process, systems and equipment to troubleshoot problems and provide solutions to senior management
• Proven leadership experience in relevant projects such as leading technology transfers and/or process changes, overseeing lengthy and complicated processes, and managing risk assessment teams
• Excellent communication and interpersonal skills for working in a small-team collaborative environment
• Great time-management skills and flexibility to work in a fast-paced start-up environment
• Ability to work off-shift and extra hours as required
Physical Demands:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. These demands include but are not limited to:
• Frequently stand; walk; sit; bend; stretch; use hands to finger, handle or feel; reach with hands and arms; and talk or hear.
• Regularly required to climb or balance; stoop, kneel, or crouch.
• Frequently lift and/or move up to 30 pounds.
• Ability to don cleanroom gowning attire
• Wear appropriate PPE for potential aerosols and subfreezing materials
To Apply:
TCRCure Biopharma provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, marital status, amnesty, or status as a covered veteran in accordance with applicable federal, state, and local laws. TCRCure Biopharma complies with applicable state and local laws governing non-discrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including, but not limited to, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.
If you are interested in applying for this opportunity, please submit your resume and cover letter. All submissions will be evaluated, and interviews will be conducted for those applicants who most strongly fit our needs. If you are not contacted for an interview, your resume will remain on file and active for available positions for a period of one year.

Quality Control Associate

Salary:

TCRCure is a clinical-stage biotechnology startup that brings novel TCR-T and CAR-T cell therapies to patients. We focus on treating solid tumors in global patient populations with few treatment options. Over the past 3 years, we have launched our first 3 generations of T cell therapies, and we need YOUR help to launch the next one.
Summary
Currently, TCRCure is seeking a highly motivated Quality Control Associate to join our Los Angeles QC team. Come help establish our QC program as we launch our first wave of cell therapy trials. We are looking for someone who can be an integral part of our quality control program as we build protocols and procedures to support the transition into GMP clinical production. This position will be based in Los Angeles, CA and the candidate will report the Quality Control Manager.

Responsibilities and Duties
• Perform in-process and routine Environmental Monitoring in ISO 8, ISO 7 and ISO 5 environments.
• Perform cell-based assays for lot release and stability.
• Perform QC testing of raw materials.
• Participate in validation/qualification activities.
• Maintain reference cell lines.
• Initiate, perform, and document laboratory investigations and non-conformances.
• Review/analyze data with respect to specifications, validity criteria, alert limits.
• Share general laboratory responsibilities, including equipment maintenance and calibration, housekeeping, and other lab support functions.
• Maintain sample logs to ensure timely testing and tracking of all samples.
• Adhere to good documentation practices to ensure data integrity and traceability.
• Organize and manage data relating to environmental monitoring and product testing.
• Maintain, revise and initiate Standard Operation Procedures, study protocols and reports.
• Work cross-functionally with Research and Manufacturing teams.
• Other duties as assigned.

Qualifications
• BS/BA in Life Sciences or related field.
• 2+ years of relevant experience within a Quality Control setting.
• Experience in GMP manufacturing and aseptic processing.
• Proficient hands-on laboratory skills (pipetting, dilutions, titrations, etc.).
• Proficiency in Outlook, Excel and other required computer applications.
• Must be able to gown for an ISO 7 cleanroom environment and work under aseptic conditions in an ISO 5 environment.
• Strong communication and interpersonal skills.
• Excellent organizational and writing skills, with a dedication to quality and compliance.
• Comfortable with the fast-paced, diverse environment of a startup company
To Apply
If you are interested in applying for this opportunity, please submit your resume and cover letter. All submissions will be evaluated, and interviews will be conducted for those applicants who most strongly fit our needs. If you are not contacted for an interview, your resume will remain on file and active for available positions for a period of one year.
TCRCure Biopharma provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, marital status, amnesty, or status as a covered veteran in accordance with applicable federal, state, and local laws. TCRCure Biopharma complies with applicable state and local laws governing non-discrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including, but not limited to, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.

Scientist

Salary:

Our research team in Los Angeles is seeking a highly motivated individual to play a critical role in viral vector discovery and process development. Primarily, the role will execute viral vector production, purification, process characterization, production scale-up, and analytical testing. At the same time, your responsibilities and priorities are expected to evolve, so adaptability is a must. Execution of accurate, up-to-date records of experiments and prompt reporting of results will be required. Individuals must be proactive self-starters who adapt to both independent and team-based tasks. This position is laboratory-based with the possibility of direct reports.

To Apply:
TCRCure Biopharma provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, marital status, amnesty, or status as a covered veteran in accordance with applicable federal, state, and local laws. TCRCure Biopharma complies with applicable state and local laws governing non-discrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including, but not limited to, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.

If you are interested in applying for this opportunity, please submit your resume and cover letter. All submissions will be evaluated, and interviews will be conducted for those applicants who most strongly fit our needs. If you are not contacted for an interview, your resume will remain on file and active for available positions for a period of one year.

Qualifications and Skills:
Ph.D. with experience in immunology, molecular biology, or a related field
Demonstrated expertise in molecular biology, cloning, PCR, and genetic manipulation
Proficiency with mammalian cell transfection/transduction, and viral vector packaging.
Experience with flow cytometers, bioreactors, FPLC, TFF systems.
Hands-on experience with stable cell lines development for retro or lentiviral vectors is preferred.
Hands-on experience with T cell or other primary leukocyte culture. Previous experience with CAR-T or immunotherapy is preferred.
Strong record-keeping skills and attentional to detail in documentation
Excellent communication and interpersonal skills for working closely with a diverse array of team members

Sr. Research Associate

Salary:

Our research team in Los Angeles is seeking a highly motivated individual to perform hands-on laboratory work. The role will have rapidly evolving priorities and ever-changing workloads, so adaptability is a must. We value teamwork and collaboration, and effectively working with scientists and other associates in the group to help our product development succeed is expected. Responsibilities include but are not limited to designing and developing strategies for novel T cell therapies; planning, and executing in vitro functional assays with human T cells or NK cells; working cross-functionally with the in vivo development team to validate novel products; performing molecular biology experiments such as PCR, cloning, DNA preparations, etc.

To Apply:
TCRCure Biopharma provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, marital status, amnesty, or status as a covered veteran in accordance with applicable federal, state, and local laws. TCRCure Biopharma complies with applicable state and local laws governing non-discrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including, but not limited to, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.

If you are interested in applying for this opportunity, please submit your resume and cover letter. All submissions will be evaluated, and interviews will be conducted for those applicants who most strongly fit our needs. If you are not contacted for an interview, your resume will remain on file and active for available positions for a period of one year.

Qualifications and Skills:
B.S or M.S. (M.S. preferred) in Biological Sciences or a related scientific discipline
3+ years of industry experience
Working knowledge and broad understanding of immunology and adoptive cell therapy
Hands-on experience with T cell, NK cell, or other primary leukocyte culture. Previous experience with CAR-T or immunotherapy is preferred
Proficiency with mammalian cell transfection/transduction, preferably with viral vectors
Experience with multiparametric flow cytometry is strongly preferred
Demonstrated expertise in molecular biology, cloning, PCR, and genetic manipulation is preferred
Strong record-keeping skills and attentional to detail in documentation
Basic understanding of GLP, GDP and GMP requirements
Excellent communication and interpersonal skills for working closely with a diverse array of team members
Comfortable and efficient in a fast-paced, dynamic, and growing environment

Research Associate

Salary:

The Research Associate is to work as part of the research and development team. Main responsibilities include target cell line development, T Cell Receptors (TCRs) and Chimeric Antigen Receptors (CARs) engineered T cells production and performing functional assays to characterize lead TCR-/CAR-T cell products. Other tasks include, but are not limited to: PCR, DNA and RNA purification, cloning, and bacterial transformation. The Research Associate will prepare technical reports and presentations to illustrate and explain experiments, data, and conclusions.

To Apply:
TCRCure Biopharma provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, marital status, amnesty, or status as a covered veteran in accordance with applicable federal, state and local laws. TCRCure Biopharma complies with applicable state and local laws governing non-discrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including, but not limited to, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.

If you are interested in applying for this opportunity, please submit your resume and cover letter to lu.zhang@tcrcure.com & nc@tcrcure.com. Applications with cover letter will be reviewed first. All submissions will be evaluated, and interviews will be conducted for those applicants who most strongly fit our needs. If you are not contacted for an interview, your resume will remain on file and active for available positions for a period of one year.

Position Requirements:
- B.S. or M.S. (M.S. preferred) in Biological Sciences or a related scientific discipline, 1-year minimum experience, industry experience preferred.
- experience in retro-/lenti-virus transduction, primary T cell culture. Primary T cell culture experience preferred
- experience in ELISA, FACS and molecular biology techniques.
- Working knowledge of molecular biology equipment and software platforms, specifically DNA construct design and sequence analysis using Vector NTI.
- Proficiency with standard software and statistical analysis is required (e.g. Microsoft Office).
- Highly organized and detail-oriented.
-team player and able to communicate experimental procedure and result clearly